Global

Hygienic Design
Infrastructure
Technical Standard
Volume II

Classified as GeneralP Business

a g e 1 | 74
Vol-1 Confidential and Proprietary — Kerry
 Global Sanitation Infrastructure Technical Standard

1. Contents
Table of Contents

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 Global Sanitation Infrastructure Technical Standard

2. Introduction
Effective Hygienic Design is based on sound scientific principles, excellent communication, common sense, and dedicated
personnel.
If you can’t see it and you can’t reach it, you can’t clean it, inspect it,
or swab it.
This Technical Standard is not intended to address every hygienic design specification, rather, it must be used in conjunction
with the Kerry Hygienic Design Principles to facilitate the identification of hygienic design flaws
and to enable mitigation strategies. This is to ensure both, the Food Manufacturing Equipment and the
Infrastructure are designed, fabricated, constructed, installed, and tested according to Regulatory and

KERRY’s requirements. Adherence to the “Principles Compliance — Hygienic Design Technical Standards” &
the information in this Technical Standard should provide assistance for effective building infrastructure design.

2.1. The Principles of Hygienic Infrastructure Design

Kerry utilizes a principles-based approach to hygienic design, all designs for manufacturing facility infrastructure and equipment
must adhere to these principles.
2.1.1. Importance of Hygienic Design Principles
 Provide an opportunity for OEM and equipment users to work together on identifying design issues of common
industry concern.
 Encourages cross-functional team participation during ideation and problem solving. There may be many ways
to achieve the desired results.
 Provide a forum to enable the hygienic design conversation to happen ahead of time rather than when
equipment reaches the plant floor.
 Create a standardized food safety focus for equipment evaluation.
 Because they are Principles, not Standards, they do not limit how the need is to be met, unlike Standards,
Principles do not need to be adjusted or bypassed constantly due to many different reasons, e.g. geographic
location of plant and surrounding areas, climate differences, country regulations, etc.
 Principles encourages/allows innovation and drives continuous improvement.
2.1.2. Infrastructure Design Principles
Introduction

Table 1 - Summary of Infrastructure Design Principles and cross references to Technical Standard section by principle.

Infrastructure Design Principle Reference

sections in this
standard
Distinct Hygienic Zones Established in The Facility 4.1, 4.2, 4.3, 4.4,

1 Maintain strict physical separations that reduce the likelihood of microbiological cross-
contamination between hygienic zones. Facilitate necessary storage and management of
4.5, 4.6, 4.7, 5.15,
6.1
equipment, waste and temporary clothing to reduce the likelihood of transfer of hazards.
Segregation of Areas for Food Safety Hazards Mitigation 4.1, 4.3, 4.4, 4.5,

2 Establish traffic and process controls for the movement of personnel, products, ingredients,
rework, waste and packaging materials to reduce the potential of food safety hazards, such as
4.6, 5.10, 5.14,

Allergen cross-contact.
Room Temperature, Air Quality, Air Flow and Ventilation 4, 6.4, 6.5, 6.7

3 Design, install and maintain HVAC/refrigeration systems for process areas to, deliver
temperature and humidity levels appropriate to the product, Hygienic Zone and process needs,
ensuring adequate air flow, air pressures, air quality
Facility Surface Drainage & Floor Design 5, 5.6, 5.7, 5.8,

4 Design and construct floors and drainage systems that are conducive to effective & efficient
cleaning/sanitation, to prevent the development of microorganisms and minimize the risk of
5.13

allergen cross-contact.
Interior Spatial Design Promotes Sanitation 2, 5.10
5 Provide accessibility to enable cleaning, sanitation, inspection and maintenance of building
components and processing equipment.
Building Components & Construction Facilitates Sanitary Conditions 5.5, 5.7, 5.8, 5.9,

6 Design building components to prevent harborage points, ensuring sealed joints and the
absence of voids. Facilitate sanitation by using durable materials and isolating utilities with
5.10, 5.11, 5.12,
5.13,
interstitial spaces and stand offs for easy cleaning, inspection and maintenance.
Utility Systems Design Prevents Contamination 5.6, 6.1, 6.2,
Design and install utility systems to prevent the introduction of food safety hazards by providing 6.3,6.4, 6.5, 6.6,
7 surfaces that are cleanable to a microbiological level, using appropriate construction materials,
providing access for cleaning , inspection and maintenance, preventing water collection points,
6.8, 6.9

and preventing niches and harborage points.

Envelope Designs Facilitates Sanitary Conditions 5.1, 5.2, 5.3, 5.4,
Design and construct all openings in the building envelope (doors, fans, louvers and utility 5.7, 5.9, 5.11,
8 penetrations) so that insects and rodents have no harborage around the building perimeter,
easy route into the facility, or harborage inside the building. Design and construct envelope
5.12, 5.14, 6.1,

components to enable easy cleaning and inspection.

Exterior Facility Elements Facilitate Sanitary Condition 3.1, 3.2, 3.3, 3.4,
9 Provide site elements such as exterior grounds, lighting, grading and water management
systems to facilitate sanitary conditions for the site. Control access to and from the site.
5.2, 5.14

Adequate Sanitation Systems 6.1, 6.9, 6.10,

Provide sanitation systems adequate to each Hygienic Zone that enable the consistent 6.11
10 execution of Wet, Controlled Wet or Dry-cleaning methods to ensure cleaning verifications and
validations can be met. This includes, washrooms, water temperature and pressure, vacuums,
COP, CIP, ACS systems.

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2.2. Scope
This document applies to all Kerry Pilot Sites, Kerry Foods, Primary Dairy, Taste and Nutrition, Joint Ventures
Manufacturing Facilities including but not limited to: Central Services, Sweet, Cereal, Savory, Liquid Beverage, Taste
Flavors, D&C, Dry Beverage, Applied Health & Nutrition (AH&N), Site Proteins & Smoke.

Engineering, maintenance, operations, safety, innovation, and continuous improvements (CI) activities involving New
Acquisitions, Food Safety improvements, Personnel Safety, Capital, Expansion that will directly or indirectly impact new
equipment or infrastructure installations, relocation, modifications, retrofitting or repairs, which may affect the food safety
of the product, the process (whole or partial), the equipment (processing or packaging), the facility (internal and external
structures, floor plans, and utilities) and/or yards and grounds.

This Technical Standard is to be followed as defined by Kerry unless applicable laws and regulations have more stringent
requirements.

2.3. Responsibilities
Regional Sanitation resource ensures that this Technical Standard is communicated and provides assistance to sites
upon request for the interpretation of the requirements and their implementation. Reviews corrective action plans based
on gaps identified by the sites. Reviews and approves proposals, risk assessments, baseline data, controls, validation
data, and review steps in dependence on process and product being validated as appropriate and upon request

Engineering ensures projects are designed according to KERRY Hygienic Design Principles by facilitating the
completion of the appropriate Hygienic Design Review Process and Principles Compliance — Hygienic Design Technical
Standards. Engineering is responsible for scheduling the reviews and providing technical resources at the necessary
gates to complete and document the design review.

Facility management or The Cross-Functional Team (for Green Field Projects) is accountable for ensuring that all the
requirements specified in this Technical Standard are implemented at the manufacturing facility. A qualified individual
who has the education, training, or experience (or a combination of these) necessary to read, understand, develop,
implement and manage the requirements included in this Technical Standard, including but not limited to:
Scope & Responsibilities

 Ensure that site-specific instructions and practices are developed, documented and followed accordingly.
 Initiate and lead verification and validation processes which includes, the proposal, risk assessment, data
collection, coordinating, and communicating activities between stakeholders.

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3. How to Use This Technical Standard”

Disclaimer: Before using this Technical Standard, is highly recommended that users read and understand the “Hygienic
Design Approval Process” standard and the “Principles Compliance — Hygienic Design Technical Standards”. Using this
Technical Standard without following the proper process sequence, may not deliver the most suitable design solution.

Provisions for mechanical and electrical safety have not been included in this Technical Standard because governmental
agencies or other standards-setting organizations provide safety requirements.

The illustrations, if provided, are intended to assist in understanding their adjacent requirements. However, the illustrations may
not include all requirements for a specific process, nor do they show the only method of fabricating such arrangements. Such
partial drawings shall not be used to justify improper or incomplete design and construction.

When specific minimum requirements must be adhered to, such requirements will be specified with the words Must, Shall, or
Will.
There are several factors that determine the requirements for fit and finish within a food
manufacturing environment, among the most critical are:
 The Cleaning Method (Wet, Controlled Wet, Dry) which is established based on the targeted
level of cleaning e.g. microbiologically, allergen, organic, religious types of cleaning.
 The product characteristics or attributes, such as acidity/alkalinity (pH), water activity (aw).
 Facility restrictions, e.g. No allergens or allergen dedicated areas/equipment only.
 Hygienic Zones
 Level of product
exposure to the environment
 Cleaning mechanisms e.g. automated systems, such as Clean In Place (CIP) Assisted Cleaning
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Systems (ACS) or Clean Out Place (COP tanks).

This Technical Standard outlines the likely design options based on the Cleaning Method. When practical and
appropriate, this Technical Standard is divided into three columns, with one column for each cleaning method; Wet, Controlled
Wet, and Dry. The “Principles Compliance — Hygienic Design Technical Standards” must be used to ensure that you have
selected the correct cleaning method and therefore the most suitable hygienic design (see Error! Not a valid bookmark self-
reference.).

Table 2 - Example of three column layouts for cleaning method specific design requirements.

Wet Controlled Wet Dry

Floors must be free draining and Floors in wet areas must be free Floors must be free draining and
appropriately sloped to drains. draining and appropriately sloped to appropriately sloped to drains.
drains.
1.5% Slope (15 mm/m or 3/16”/ft) is For completely dry areas floors
generally sufficient to provide free draining. 1.5% Slope (15 mm/m or 3/8”/ft) is must generally be flat <1% (<
generally sufficient to provide free 10mm/m or 1/8”/ft)
For consistently wet areas slope must be draining.
up to 2% (20 mm/m or ¼”/ft).
For chronically wet area’s slope must
In especially greasy areas floors with be up to 2% (20 mm/m or ¼”/ft).
steeper slopes will require more slip
resistance to ensure worker safety. In especially greasy areas floors with
steeper slopes will require more slip
resistance to ensure worker safety.

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4. Cleaning Method Selection

The “infrastructure hygienic design assistant’ worksheet located in the “Infrastructure Principles Compliance — Hygienic
Design Technical Standard” must be utilized to determine the most suitable cleaning
method.
Table 3 - Descriptions of different cleaning methods

Wet Controlled Wet Dry

This applies to areas where the Applies where manual techniques using Dry cleaning is cleaning where no aqueous
entire room or zone is always a minimum controlled amount of water is cleaning liquids are used, and cleaning is by
cleaned wet. The contents applied. Unlike WET cleaning, water but not limited to vacuum cleaners, dusting
(equipment, cable trays, ceilings, spraying devices (e.g. water hoses) are cloths, brooms, and brushes. Dry cleaning is
walls etc.) are wet washed without not used, in their place damp cloth, applicable for dry food material contact
restrictions on the amount of microfiber towels or single use wipes are surfaces where:
cleaning and rinsing liquid used. used to remove product residue. A  Dry material remaining in the equipment
combination of wiping, scrubbing, as loose layers or dust covering does not
scraping, vacuuming, brushing are present any risk of degrading the quality of
commonly used techniques. Normally the dry material subsequently produced.
recommended in areas in which the  Possible cross-contamination of dry
product/soil cannot be removed by the material during a production change to
application of Dry-Cleaning techniques another material presents no problem to
only, or in areas in which proper the quality or safety of the dry material
drainage is not available and in which full subsequently produced or the carryover of
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WET methods would create a potential allergens into subsequent

microbiological risk to the environment production.
and/or the equipment.  Dry material remaining in the equipment
does not present any risk of microbial
growth occurring due to the prevailing
Note: Controlled wet cleaning may not moisture content, temperature and
be efficient, is very labor intensive humidity conditions.
and may have some challenges with  Dry material is non-hygroscopic and non-
validation. sticky.

Note: Dry cleaning methods may be

challenging to validate.

Must be used when the Not recommended when the Must NOT be used when the
targeted level of targeted level of cleaning is targeted level of cleaning is
cleaning is microbiological or allergens allergen clean.
microbiological or clean
allergens clean

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Table 4 – Example Products and processes for different cleaning methods.

Wet Controlled Wet Dry

 RTE Micro-sensitive products  Some Confectionary equipment  Dry ingredients bulk
 Infant formula such as refining and conveying unloading for flour, rice,
 Meat (beef, pork, poultry) or generally after tempering. sugar, salt, oats, etc.
 Sea food  Baking equipment, generally  Packaging equipment for dry
 Produce after ovens and/or dryers and products
 Some confectionary equipment, such as before packaging, such as  Conveying for dry ingredients
depositors, coating pans, conveying and molding. conveying (belts or bucket or products, belts (cloth or
elevators).
 Some cereal equipment, generally cooking and vinyl).
 Cereal equipment after ovens
drying equipment before ovens, such as cookers,  Baggers and scales
and before packaging.
multizone dryers, coating drums, etc.  Electronic components not
 Artificial Sweeteners
 Some Baking equipment such as upright mixers;  Baking Powder / Cream of >IP 67
generally, before ovens or dryers. Tartar  Baler compactors
 Washrooms  Biscuit / cookies / crackers /  Case packing
 Weighting rooms (allergens) wafers / fillings / with and  Some Chocolate processing
 Wet blending without sensitive dry ingredients (no allergen cleaning)
 CCP equipment such as metal detectors or x rays  Candy, Hard & Soft  Dry batters/breaders
located in a wet cleaning environment.  Some weighting rooms with no  Bagging of dry powder
 Allergen dry blending allergens or allergen dedicated. ingredients (non-micro
 Spray dry premix  Some electronic components or sensitive)
 CIP/ACS/COP Rooms equipment such as PLC  Warehouses
 Dairy - Butter/Margarine, Cheese Products, Cold screens and metal detectors or  Maintenance Shops
filled RTE; Cheese Products, Hot filled RTE x ray machines.
 Cultured Products: Yogurt, Sour Cream and sour
cream products, Cottage Cheese, RTE Yogurt
Drink
How to Use This Manual

 Desserts – RTE Refrigerated Pudding Snacks.

 Beverages, RTD (Liquid, includes acidified Shelf-
stable, high acid, and shelf stable no juice
formulations).
 Dressings & Sauces (BBQ Sauce, Steak sauce and
Marinades, Ketchup, Mustard, Red Sauces,
Pourable dressing, Viscous dressing, etc.)
 Hummus Spreads and Cold Pack Cheese Spreads
 Ice Cream Toppings (Liquid topping such as
caramel syrup)
 Peanut Butter
 Spray Dried Powdered Products: Cheese, Milk,
Whey, Creamer; Dream Whip, NFDM, etc.
 Sicky, fatty, oily products, with medium to high
volumes that need quick removal and can’t be
cleaned by Controlled Wet or Dry methods.

Ribbon
Blender
Powder &
Liquid Mixer

WET cleaned

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Chocolate
Molding Line
How to Use This Manual

Chocolate
Refiners

Rollers are generally

controlled WET
cleaned. The top and
sides of the refiner
(electronic
components) are DRY
cleaned.

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5. Site Requirements, Yards, and Grounds

5.1. Site Selection – (Infrastructure Principal 9)

Food factories should be sited to provide ready access to services necessary for producing safe food, most significantly potable
water. Additionally, sites should contribute to minimizing risk of contamination from businesses, buildings, and other adjacent
land use. Factory buildings and the surrounding area must be designed and maintained in a way the prevents conditions that
may put food at risk.
Wherever possible factory sites should be located away from the following:
 Environmentally contaminated or otherwise polluted areas.
 Geological faults or other natural hazards.
 Rivers, marshes, canals, ponds
 Areas subject to flooding. Note: flooding is a major food safety risk and must be considered. A thorough
flood risk assessment must be performed, particularly for micro-sensitive products.
 Industrial or waste handling areas that may create objectionable odors, dust or smoke, and other
contaminants such as: landfills, recycling facilities, incinerators, slaughterhouses, rendering operations,
chemical treatment plants/refineries, paper mills, or waste treatment facilities.
 Operations not under the plant’s control that may promote harborage of rodents, insects, birds, and other
pests. Examples may include junk yards, brush, abandoned or unmaintained properties.
 Areas where wastes (solid or liquid) cannot be effectively removed or otherwise managed.
 Residential Areas
 Local requirements for air emissions, e.g. odor, particulate, etc.
Site Requirements, Yards, And Grounds

Sites must comply with existing environmental regulations as appropriate for the region.
Impact of raw material, finished product, and waste handling must be considered with regard to product food safety and the
neighboring environment.
After site selection any hazards from neighboring facilities and environment should be accounted for and the factory must be
designed to mitigate those risks.

5.2. Site Plan – (Infrastructure Principal 9)

A site plan provides a framework for risk assessment and control and HACCP planning related to new factories, or significant
additions to external facilities. A site plan should consider the management of hazards as part of the HACCP study as well as
being the basis for any specific discussions on engineering projects.
Site plans may contain:
 A building layout locating production areas, Service areas, storage areas (e.g. chemicals), surrounding areas
and main air intake/outlet locations.
 The relevant hazards established from HACCP or equivalent hazards studies including possible cross flow
between sensitive and potentially contaminated material.
 Access for personnel and traffic (for incoming and outgoing material).
 Location of nearby rivers, canals or other water catchments areas (e.g. ponds, lakes, marshes).
 Site terrain elevation indicating slopes for natural drainage.
 Neighboring non-industrial sites e.g. commercial buildings, food outlets, housing etc.
 Waste collection areas.
 General direction of the wind with reference to odor and airborne contaminants, such that factory design can
mitigate these risks.
 Main plant areas defined in terms of a hygienic zone classification, their functions and planned cleaning
practices in these areas.
 Movement of personnel, vehicles and materials including raw materials, packaging materials, intermediate
products and waste. The impact of trafficking of materials in and out of the site should be considered, both to
food safety issues for the product (e.g. microbiological risks from the transport and lairage of animals) and to
the surrounding community (e.g. the noise generated from vehicle refrigeration units).
 Location of utilities including the wastewater treatment plant.

5.3. Site Requirements – (Infrastructure Principal 9)

5.3.1. General
The Site Should:
 Have clearly defined boundaries e.g., a perimeter fence or wall, with controlled access to the factory grounds
to keep out animals, pests, or unauthorized persons.
 Have a high quality and constant water supply available
 Control the risks of open water ways that attracts birds, insects, vermin, etc.
 Have separate utility buildings, trailers, garages, wastewater treatment facilities, storage sheds, guard
shacks, and well houses generally designed to meet security and pest control strategies.
 Ensure the building has adequate freeboard over site water levels assumed in flood risk assessment design
storm events.
 Finished floor elevation/grade is higher than adjacent grades to prevent storm water ingress.
 External operations (e.g., trailer cleaning, bulk storage, waste/trash & waste management) are designed &
positioned to prevent unsanitary impact on the facility
 Roadways, parking areas, yards and grounds should be designed and maintained in a manner that will
prevent the possible adulteration of food.
 Have adequately draining areas or installed external drainage. All areas should be graded to storm sewers.
External and storm drainage should not pass under food processing areas
 Have proper facilities for discharging waste streams.

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Figure 1 - Example Site Plan

5.3.2. Yards, Grounds and Landscaping

 Yards and grounds should be sealed or otherwise surface, drained and graded. Appropriately maintained
lawns and landscaping is effective for sealing large non-traffic areas.
 Roadways and parking areas should be of dense, hard, compacted and dust sealed material (e.g. concrete,
asphalt or other paving) suitable for wheeled traffic. Adequate paved parking shall be provided for all
personnel and visitors.
 Paved walkways shall be provided for all exterior walkways. Trees shall not be located where branches can
hang over the walkways to minimize foot contamination from bird droppings as a result of birds roosting in the
trees.
 All paved areas should have suitable slopes to prevent accumulation of water.
 Detention and retention basins should not be located on factory grounds. When required they must be
properly designed, maintained and operating to eliminate unnecessary standing water.
 Rain water drain pipes and manholes should have screens of 6mm / ¼ inch stainless steel mesh to prevent
rodent harborage.

Figure 2 - Screened manhole grating (Source - Nantong Phase 3)

 All outbuildings shall be constructed to prevent harborage of snakes, rodents, birds and/or insects.
 Garbage receptacles are avoided, if needed, adequate waste/trash receptacles are provided in pedestrian
areas and designed not be a source of contamination.
 Concrete pads pitched to a drain to accomplish cleanup shall be provided for dumpsters and other outside
disposal devices to prevent pest attraction.
 Grounds should minimal vegetation and foliage. When present, shrubs and plants should be located at least
3 m / 10 feet and trees located at least 9 m / 30 feet from buildings. Any unpaved roads must be at least 6 m
/ 20 feet from the building. (Figure 3- Gravel Strip and Landscape Distance
 To reduce rodent infestation and facilitate building inspection a gravel strip at least 90 cm / 36 inches by 10
cm / 4 inches of asphalt, concrete, or pebbles (6mm / ¼ inch) shall be provided adjacent to the facility.
Plastic sheeting may be used below the gravel for weed control. (Figure 3- Gravel Strip and Landscape
Distance

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Figure 3- Gravel Strip and Landscape Distance

Site Requirements, Yards, And Grounds

Figure 4- Factory with gravel rodent control strip

 Buildings should be free of vegetation.

 Grounds should have weed control to reduce harborage for insects and rodents and to prevent air-borne
seeds.
 Wherever possible outside equipment and equipment storage should be elevated above a concrete pad to
prevent rodent harborage. Mounting shall be designed to be cleanable and inspectable.
 All open pipe ends shall be screened with a ¼-inch (6 mm) mesh to prevent rodent harborage. It is illegal to
restrict vent pipes from pressure relief valves for steam, ammonia, compressed air, process vessels, etc.;
however, these can become harborage areas especially when equipment is left idle for a period of time. To
avoid restricting them, provide cylindrical or other shaped screens with an open area equal to at least twice
the cross-sectional area of the pipe, unless specifically forbidden by local ordinance or code.
5.3.3. Site Lighting
Adequate lighting of the factory grounds shall be provided for security, including illumination of car parks, facility entrances, and
all access points for storage of food ingredients or products. Lighting should be placed/mounted away from the building to
prevent the attraction of insects to the building. External lights should be angled downward or towards the buildings, never
upwards or away from the buildings. For external applications high pressure sodium lights or equivalent lights that emit low
Ultraviolet (UV) are preferred. Mercury vapor lights or other lighting that emits high UV rays should be avoided, if they must be
used they should be mounted at least 10m / 35 feet from doors.

Figure 5 - Location of external site lighting. Incorrect (left) and correct (right).

5.4. Site Boundary and Access Control – (Infrastructure Principal 9)

5.4.1. Controlled Site Access
The site and production/storage areas of the factory buildings must be effectively secured by controlled access in order to
prevent unauthorized entry. Site security should be reviewed, and the need for close circuit television (CCTV), and/or security
guards should be considered as part of a food defense program.
In particularly, material storage tanks, silos, and line hook ups must be provided with adequate enclosure, security, drainage,
space, and spill control.

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5.4.2. Fencing and Walls

 Fencing around the site should be 250 – 300 cm (8’ – 10’) high, preferably of climb and cut-resistant wire
mesh, and/or an intrusion detection device should be installed. Block, brick, or concrete walls with
appropriate climbing prevention are also acceptable.
 A concrete or brick wall base below wire fencing approximately 50 cm (20 inches) may be used to provide
addition rodent control where required.
 Fencing must be of sufficient height to effectively filter pieces of paper and other debris.
 Fencing must form a barrier to cats, dogs, and other domestic animals.
 Where necessary to prevent standing water a drainage channel or a border of pebble/concrete should be
provided.
 An area minimum of 50 cm (20 inches) on both sides of the fence should be clear of trees, bushes, plants
waste and structures.
 There should be no buildings against the wall (or fence) – unless a 1 meter / 36 inch space between the two
is provided for cleaning and inspection. Exceptions being the case when the building is providing the
boundary wall.
 Breaks in the wall or fence must only be provided for personnel and goods entry/exit. Breaks must be
provided with appropriate security barriers. Ideally, access should be limited to a single entrance with a gate
house.
Site Requirements, Yards, And Grounds

Figure 6 - Example barrier fence (Nantong CN)

Figure 7 - Example barrier fencing. (Nantong CN)

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6. Building Layout and Hygienic Zoning

All food processing operations must be carried out in a way in which the risk
of contamination of the food
product or packaging materials by any hazard1 (including other food
ingredients/products) is avoided. Such hazards may include:
 Microorganisms (e.g. Listeria spp., Salmonella, [Link], etc.)
 Allergens
 Foreign bodies (e.g. metal, glass, plastic, insects)
 Chemicals (e.g. cleaning chemicals, lubricants, allergens)

Segregation of ingredients is required with respect to handling, labelling or brand protection issues, including:
 Wet and dry storage and production areas
 Vegetarian product claims (in a factory handling meat ingredients)
 Organic product claims (in a factory handling non-organic ingredients)
 GMO free claims (in a factory handling GMO ingredients)
 Halal or Kosher claims (in a factory handling non-Halal or Kosher ingredients)
 Meat species claims (in a factory handling mixed meat species - pork, beef, chicken, lamb etc.)
Building Layout and Hygienic Zoning

Manufacturing facilities must be designed to minimize the risk of contamination from one product to another. The contamination
risk may be reduced by:
 Manufacturing in separate locations/factories
 Separation of operations within the same factory
 Enclosed systems, partitions, or airflow
 Time with effective intermediate cleaning and sanitation

6.1. General Requirements – (Infrastructure Principal 1,2)

Buildings must be located, designed, constructed, adapted, and maintained to suit the operations carried out in the
facility, for the placement of equipment and storage of materials, to provide adequate space to allow the
hygienic performance of all operations and to facilitate cleaning and maintenance.
Access of personnel and visitors must be controlled. Designated walkways must be provided and marked in internal and
externa areas such that by simple logical routes, the traffic pattern of personnel (and vehicles) must prevent cross-
contamination or cross-contact.

Good hygienic operations must:

 Have the least possible number of personnel entries or opening to the exterior, while ensuring security and
safety, e.g. fire escape requirements.
 Provide main exterior employee entrances located away from waste and refuse
areas.
 Provides all openings to the outside (if not permanently closed) with solid doors or glazed windows, insect
proof screens, and/or self-closing mechanisms.
 Provides physical internal separation by walls between departments in which edible
(e.g. food products, food packaging and other food ingredients) and non-edible materials (e.g.
boiler rooms, workshops, machinery rooms, living accommodations) are handled.
 Provides physical internal separation by walls between departments in which edible
materials (e.g. food products, food packaging and other food ingredients) are processed and with any
area in which gas, fumes, dust, soot deposits, offensive odors, or any other
impurity is present.
 Reduce cross-contamination2 by segregation that considers the flow of product, nature of
materials (e.g. raw vs cooked, allergen vs non-allergen), equipment, personnel, waste, airflow, air quality and
utilities.
 Provides separate storage areas for raw materials, final products, chilled or
frozen products, packing materials, cleaning supplies and equipment, and any other equipment.
 Minimizes “crisscrossing” of products, raw materials, services, personnel, and wastes.
 Provide suitable temperatures-controlled building and storage conditions.
 Permits segregation of non-conforming facilities and materials.
 Provides separate routes of entry and movement for vehicles and personnel.

1 Hazards, identified in the hazard analysis, that are of sufficient severity and likelihood of occurrence that one or more preventive controls are needed to significantly minimize or prevent the
food from becoming contaminated or produced under conditions that could cause contamination.
2 Cross-contamination refers to the transfer of microorganisms to food products from other sources such as raw materials, equipment surfaces, utensils, etc. as a result of improper handling,
which renders the food unsafe.

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6.2. Zone assignment– (Infrastructure Principal 1, 2)

Risk assessments must be performed for each room or area within a factory and used to
assign an appropriate hygienic zone. The “Kerry Hygienic Zoning Global Standard” outlines 7 different hygienic
zones (listed below). A general decision tree for required hygienic zone is provided in the “Principles Compliance — Hygienic
Design Technical Standards” and the zoning standard. further guidance please refer to the “Global Hygienic Zoning standard,
and Zoning standard appendix 1”

6.2.1. Non-GMP Zone

Areas that are part of the manufacturing site, but not associated with food production or storage.
Ingredients, WIP or finished goods are never taken to these areas.

Example areas: reception area, administrative offices, cafeteria/canteen, laundries, smoking areas, boiler rooms, electrical
rooms, plant grounds.

6.2.2. Basic Care Zone

Areas where ingredients, WIP3 or finished goods are handled or stored while fully protected by primary
and/or secondary packaging.
Areas where ingredients or WIP are sealed within processing equipment or piping and
cannot be exposed to the manufacturing environment during production may also be included in this zone.
Building Layout and Hygienic Zoning

Areas where food contact equipment, tools or part are handled or stored may also be included in this
zone. There is no direct exposure of ingredients, WIP or finished goods to the manufacturing environment minimizing the
potential risk of cross-contamination.

Example areas: ingredient storage, finished product storage, liquids full enclosed in pipes, milk pasteurizer, retort loading,
case packing, palletizing, maintenance shop, office in production areas

6.2.3. Medium Care Zone

Areas where NRTE or RTC ingredients, WIP or finished goods are handled.
Areas where ingredients or WIP are handled prior to a controlled pathogen lethality step.
Areas where Non-Sensitive RTE ingredients, WIP or finished goods are handled.
Ingredients, WIP or finished goods are exposed to the manufacturing environment in these areas.
The risk posed by potential cross-contamination is minimized by a down-stream process (i.e.
lethality step, hot filling or consumer cook). OR It has been established that the inherent characteristics of the ingredients, WIP
or finished goods minimize the risk.

Example areas: NRTE dry blending, RTC meal assembly, hot filling above 71C (160F), filling liquid flavor with >12.5%
alcohol

6.2.4. High Care Zone

Areas where Microbiologically Sensitive RTE ingredients, WIP or finished goods intended to be consumed by
the general populations are handled.
It is expected that these ingredients, WIP or finished goods could be safely consumed without any
further treatment.
Ingredients, WIP or finished goods are exposed to the manufacturing environment in these areas.
The risk posed by potential cross-contamination is minimized by control of the manufacturing environment including materials,
equipment, tools, and people entering these areas.

Example areas: RTE dry blending, chocolate molding, peanut butter filling, cereal pouching, RTE meat slicing, RTE meal
assembly

6.2.5. Critical Care Zone

Areas where Microbiologically Sensitive RTE ingredients, WIP or finished goods intended to
be consumed by infants or other susceptible populations are handled.
It is expected that these ingredients, WIP or finished goods could be safely consumed without any further treatment.
Ingredients, WIP or finished goods are exposed to the manufacturing environment in these areas.
The risk posed by potential cross-contamination is minimized by control of the manufacturing environment including air,
materials, equipment, tools, and people entering these areas.

Example Areas: Filling powdered infant formula

6.2.6. Restricted Zone

Areas that are part of the manufacturing site and are known to have, or likely to have contaminants present.
These areas must be completely contained with access restricted to designated personnel to minimize the potential risk of
cross-contamination of other hygienic zones.

Example Areas: microbiology laboratory, chemical storage, wastewater treatment plant

3 WIP refers to the raw materials, labor, and overhead costs incurred for products that are at various stages of the production process.

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Building Layout and Hygienic Zoning

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6.2.7. Transition Zone

Areas where the different hygienic zones intersect. These are areas where control measures are taken to minimize the
potential risk of cross-contamination between adjoining hygienic zones.
Building Layout and Hygienic Zoning

Figure 8 - Example of Transition Zone

6.3. Flow Requirements – (Principle 1, 2, 3)

The cross-functional team must inquire the following details:
 Product
 Processes and materials flows, some of which are likely to be available from the product specification and
business plan.
As a minimum, the following information is required. If not readily to hand, some information can be found by
observing and recording current operations of existing products. In the absence of key information, estimates can be made to
quickly build up a general plan.

6.3.1. Raw materials

Define the raw materials to be used, in terms of type and quantity.
 How much storage space is required and how is ingredient storage to be segregated (e.g.
vegetables from meat)? Is there the requirement for a separate dry goods store?
 What are the ingredients to be stored in (bag, box, tray, bins, silo, etc.) and at
what temperature? How much room is required for initial de-boxing?
 What is the number of days’ storage required per ingredient? Is a ‘just-in-time’
operation envisaged, or will deliveries be once per week/month, etc.?
 What is the ideal ‘goods in’ arrangement? Will deliveries be by van or large lorry? How
much space is needed on site for the safe maneuvering of delivery and dispatch vehicles? How will
ingredients be transferred to a (preferred) receiving dock – is there a need for forklift truck storage/
recharging?
 W here and how will incoming ingredient pallet separation be controlled? Will internal plastic/aluminum, etc.,
pallets be used? Where will they be stored?
6.3.2. Process
 For each intended product, define the processes required through preparation, processing,
portioning and packaging.
 Are there any requirements for the segregation of ingredients, components or finished
products based on e.g. microbiological status, allergenic status, presence of genetically modified organisms
(GMOs), suitability for vegetarians, suitability for religious groups (Halal, Kosher), suitability for ‘organic’
labelling or meat species?
 Where is there likely to be the requirement
to store work in progress?
 What is the required storage temperature and tolerances?
 Are specific processes required, e.g. cooking, steaming, baking, frying, chilling, freezing?
 Are there any particularly large pieces of equipment required that might determine the building size (e.g.
ceiling height)?
 Are there any items of equipment that might require special installation requirements e.g. substantial floor
slabs, fire protection, noise suppression, specialist services?
 What are the cooking and cooling throughput per product and the cook/cool residence
times?
 What is the general process plant type and location?
 How many product flow streams are required, i.e. how can process lines be optimized to accept the maximum
number of intended products with the fewest lines?

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 What are the requirements for forklift/ hand pallet movement and charging (if
required)?

6.3.3. Finished goods

 What are the finishproduct packaging dimensions and print requirements?
 What are the requirements for final product storage and the number per
crate/pallet?
 What are the final product pack size, dimensions and weight?

6.3.4. Storage and distribution

 Define the finalproduct storage temperature and tolerances.
 Define the number of intended days of storage prior to distribution. Will the product be
positively released based on microbiological and/or quality testing?
 Consider the optimum design of the dispatch area. Is there the need for temperature-
controlled docking?
 Will trays/bins, etc., be returned that need cleaning before re-packing?
 Will the transport vehicles be company-owned or contracted? Is there the requirement for vehicle
garaging/cleaning/servicing?
Building Layout and Hygienic Zoning

6.3.5. Environment
 For each storage and processing area, define the required room temperatures and
tolerances.
 Will there be the requirement to remove condensation or dust particles?
 What are the required levels of air filtration, air changes/hour and air pressures?
 Is there a requirement for controlled relative humidity air control?
 Has the runoff of fire-fighting water been considered?

6.3.6. People
 What is the number of people required, both administrative and food operatives (including
nightshift/cleaners), to staff the operation?
 What shift patterns are envisaged and what is the number per shift, i.e. what is the maximum
number of people on site at any one time?
 Are separate entrances required for food operatives, office staff, visitors?
 Is there the need for high risk/low risk entrance barriers?
 Will the company supply catering services or provide a canteen/restroom area?
 Define the company smoking policy, including the provision of any (external) smoking areas .
 Will the company provide a medical room?
 What is the requirement for disabled access in all processing areas?
 What are the management and administration requirements?

6.3.7. Waste
 How will ingredient packaging waste be handled?
 How will solid process waste be handled?
 How will packaging waste be handled?
 Will wastes be stored outside in covered containers or within the buildings?
 Will liquid wastes require screening within the factory (e.g. drain baskets) or externally?
 Will liquid wastes be discharged directly to the municipal sewer or be fi rst treated on-site?
 What type of wastewater discharge consent can be obtained? Does this consent require waste-
water treatment to meet any imposed effluent parameters?

6.3.8. Cleaning
 How many washrooms/cleaning rooms will be required, including equipment dirty storage
and cleaned and drying storage areas?
 Where will cleaning equipment
and chemicals be stored?
 How will cleaning chemicals be delivered and in what volumes – 25-liter drums or larger
transport tanks?
 How will cleaning fluids be distributed around the processing areas – manually or via cleaning ring mains?

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6.3.9. Service
 What is the requirement for power (for process steps, heating, ventilation, etc.) consumption? Is a
back-up electricity supply necessary?
 What is the requirement for water? As far as possible, the main cold water feed to the factory must
be installed underground and not within the building as this would cause the water temperature to rise and
increase the chance of Legionella bacteria.
 What is the requirement for gas?
 What is the requirement for compressed air?
 What is the requirement for hot water?
 What is the requirement for steam?
 Does the company have a refrigeration policy?
 What is the requirement for storm water?
 Define the drainage layout including segregation of any low and high-risk drains?
 What building management systems will be required?
 What is the requirement for fire control (sprinkler systems, fi re alarms, fi re hydrants)?
 How will services be incorporated into processing areas (e.g. services supplied via service corridors, false
ceilings or basement/underground tunnels)?

Facility must be designed to provide a flow pattern for food products, personnel, equipment, and process waste to prevent
contact of the finished product with raw materials. Flow
must be in one direction and follow a logical
Building Layout and Hygienic Zoning

sequence from raw material handling to finished product storage. Within this flow must
be the concept of hygienic zoning.

In addition to the cleaning methods employed, the degree of hygienic design applied to the high hygiene area will depend on
the degree of microbial decontamination undertaken, the likelihood of spoilage and pathogenic microorganism growth or
survival in the product, and the risk of cross-contamination from the external environment.

When laying out process and support areas the following must be considered:

 Where practical and possible flow and layout must provide for complete segregation between
Raw and RTE product, preferably with dedicated personnel and dividing walls.
 Where possible hygienic zones must not be skipped (e.g. travel from Non-GMP zones
Directly to High Care zones)
 Space may need to be dedicated to transition zones (see Section 0)
 Different Hygienic Zones may require designated washrooms / cleaning rooms, trash areas, and personnel
hygiene controls.

Figure 9 - Example factory schematic representing food manufacturing zones showing potential routes of product flow
dependent on the product’s need for microbiological protection.

Figure 10 - Example factory schematic showing separation of non-microbiological hazards via horizontal segregation.

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6.4. Segregation/Specifically Dedicated Spaces – (Infrastructure Principal 1,2)

Facilities must provide segregation for high risk processes such as Microbiology Labs. Other areas
requiring segregation include

 Waste and animal feed loadout

 Personnel Hygiene and Welfare
 COP/CIP Rooms and washrooms/cleaning rooms
 Wastewater Treatment

6.5. Engineering Control Measures – (Infrastructure Principal 1,2)

Transition areas must be provided when people, products, materials, waste, or
equipment are moving from one hygienic zone to another. The complexity and hygienic design
requirements for a given transition area will vary depending on the zone’s being transferred between.

Appropriate levels of air filtration and pressure differentials must be maintained between adjacent zones to
reduce the risk of microbial contamination and allergen cross-contact. Further information on HVAC and airflow/quality is
provided in (see 6.4 - HVAC).

Physical barriers must be provided between different hygienic zones. The level of physical
barrier required will vary based on difference between the hygienic zones. Further information on transition zones is provided in
Building Layout and Hygienic Zoning

(5.10 - Airlock and Transition Rooms). Physical barriers may include:

 Transition zones / Vestibule
 Hygiene junctions / Transition Zone
 Material pass boxes / rooms
 Doors
 Material pass-thru windows
 Floor demarcation lines (not tapes or adhesives)
 Benches

Transition to Critical High Care and High Care zones must be through transition zones
with door interlocks. Visual instructions for proper compliance to hygienic practices must be available and provisions
for the required garments, cleaning/sanitizing and trash disposal must be available and maintained on an ongoing basis.

6.6. Room Book Sheet – (Infrastructure Principal 1)

A room book sheet identifying all rooms in the facility/design must be provided. At minimum, a Room Book Sheet must contain
the following elements in the Manufacturing Facility drawings (not an exhaustive list):
 Building structure such as roof access, door access and window distribution
 Employee entrances, visitor, contractor entrances
 Materials storage/warehouse
 Employee welfare facilities (locker room, changing area, rest rooms, laundry, etc.)
Personnel Hygiene junction
 Drain including placement, design, position and flow
 Production entrances
 Raw Materials preparation area (including packaging)
 Finished goods filling and packing area
 Waste handling and traffic
 Waste and waste/trash Rooms/compactors
 Raw Materials/Finished goods loading/receiving area
 Equipment
 Product flow and nature of the materials
 Maintenance workshops
 Utility rooms such as air filter room, water treatment room, boiler house, compressed air room and utilities
distribution
 Washrooms (cleaning rooms)
 Cleaned equipment storage
 Cleaning tools, utensils and supplies storage
 Flow of air and air quality
 Quality Laboratories
 Hygienic Zoning Map showing flows (Detailed Example as Supplemental Document)

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7. Requirements for Building Fabric

7.1. General Criteria and Materials of Construction – (Infrastructure Principal 8)
Building fabric must be designed installed and finished in a manner that supports the overall hygienic quality of the facility.
Design must avoid creating pits, voids, cracks, or other areas where water, soil, dust,
food residue, or other debris may collect, or pests may harbor.
Surfaces of materials, coatings, and surface treatments shall be smooth, hard, durable, cleanable, and if necessary, capable of
being sanitized without breaking, cracking, chipping, flaking, delamination, erosion, corrosion, abrasion, and shall be resistant to
the penetration of unwanted matter under intended use (non-absorbent).
Paint and painted surfaces create an ongoing maintenance challenge and product contamination risk and must be
avoided wherever possible, particularly in any food processing areas or in areas that are wet or controlled wet cleaned.
Where paint must be used it must be selected for maximum durability under the harshest expected conditions.

7.1.1. Materials of Construction

Table 5 - Acceptable materials for infrastructure construction by cleaning method

Wet Controlled Wet Dry

Stainless steel 304-316 or similar Stainless steel Stainless steel
corrosion resistant alloys suitable for Galvanized Mild Steel Galvanized Mild Steel
the conditions of use. Carbon Steel
Class 1 (highly durable) Class 1 + Class 2 (moderate, Class 1 + Class 2 + Class 3
Requirements for Building Fabric

acceptable durability) (corrosion & chemical sensitive)

Stainless steel AISI 304(L), AISI 316(L) Hard chromium plated steel Galvanized, carbon and painted steel
Hastelloy B &amp; C Nickel-plated steel Cast iron
Titanium Nickel-plated brass Bronze and Brass
Polyvinyl chloride (PVC) Nickel-plated Copper
Teflon (PTFE) Anodised aluminium Zinc
Polypropylene (PP) Nickel Polycarbonate
Polyethylene (LDPE, HDPE) Acrylonitrile butadiene styrene (ABS)
Polyvinylidene fluoride (PVDF) Polyamide (PA)
Polysulfone (PES) Polyacetal plastics (POM)
Polyetheretherketone (PEEK) Phenolic resins (PF)
Polystyrene (PS) Ureum and melamine resins (UF, MF)
Polymethylmetacrylate (PMMA) Polyurethane rubber (PU)
Epoxy resin Nitrile rubber (NBR)
Neoprene rubber
Ethylene propylene diene monomer
(EPDM)-rubber

7.1.2. Unacceptable materials

The following materials are not acceptable:
 Materials containing antimony, arsenic, cadmium, lead, or mercury
 Materials classified as hazardous substances (such as carcinogens, mutagens and teratogens)
 Asbestos and asbestos containing materials
 Wood
 Enamelware
 Porcelain
 Leather
 Uncoated aluminum and aluminum alloys
 Uncoated anodized aluminum and aluminum alloys

7.2. Foundations – (Infrastructure Principal 8,9)

After selecting the site location, the second consideration of sanitary design is the foundation and the supporting structure. Some
food processes are better housed in multi-storied buildings, others in
single-storied buildings. Deciding which building type to use must consider the product to be processed, amount of land available and local
codes.
Some processes that have many components to the process, or a sensitive product, may be better suited to a multi-story plant so that
product can be transferred by gravity rather than conveyors, elevators or other powered mechanical transport systems that have inherent
sanitation problems.

Factory foundations shall structurally stable and be concrete based (avoid wood, brick,
and block foundations.)
Foundation design must account for variable loads during the life of the factory including:
 Equipment vibration
 Large variable loads e.g., silos filling/emptying.

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Foundations must be at least 60

cm / 24 inches below grade and must be coated with an
appropriate waterproofing (e.g., asphalt). Adequate planning for storm water management must be considered as
part of design and site preparation including installation of drain tiles around the foundation perimeter.
The outer walls of a food processing facility must be constructed to be rodent
proof.
To prevent pest ingress, for a slab floor, the footers should be constructed with a rodent flange 24 inches (61 cm) below grade
level extending 12 inches (30.5 cm) at right angles to the foundation. This flange will prevent rats from burrowing under the floor
slab and chewing their way through vulnerable places into the plant. Vulnerable places include:
 Expansion joints and drain lines.
 If the building is to have a basement or cellar, its floor should be tied directly to the solid wall foundation. This
will create a solid box effect that will be an effective pest barrier. The basement walls should be waterproofed
prior to backfilling. In clay-type soils where drainage is poor drain, tiles should be placed around the entire
foundation to handle any anticipated ground water problems. Sloping the flat surface of the footing on the
exterior side of the wall will prevent water from accumulating on the footing.
Foundations must be designed to prevent the access of pests into the building. To prevent rodents entering
the building foundation must include an L-shaped foundations 60-90 cm / 24-36 inches below grade with a horizontal slip
extending 30 cm / 12 inches away from the base, or with a curtain wall of concrete or galvanized sheet metal of similar
dimensions (See Figure 9 - Foundation designed to prevent pest entry).
Requirements for Building Fabric

Figure 11 - Foundation designed to prevent pest entry

7.3. Superstructure – (Infrastructure Principal 8)

7.3.1. General Requirements
Structural elements shall be designed to minimize accumulation of dirt and debris, and minimize
opportunities for pest harborage.
Structural members shall provide a minimum amount of flat horizontal surfaces to avoid ledges.
Columns shall be of tubular steel, structural shapes encased in concrete or reinforced concrete construction. If concrete or
concrete encasement is used, corners shall be beveled or rounded and the intersection at the floor shall be coved to eliminate
soil collection from a right-angle joint.
Tubular steel or box sections shall be used where possible for beams. Tubular or box sections must have sealed ends. All
connections to such beams must be welded. No drilling of hollow sections is allowed. If other structural shapes (I-beams,
channels, etc.) must be used, fill all webs and voids with an inert material such as concrete, grout, or encase in concrete.
Exposed steel structures must only be used for processes with lower hygienic requirements. Exposed steel must be protected
by galvanizing or plating (e.g. zinc).
Alternative shapes such as I-beams or joists must are acceptable only in basic hygiene
zones. A risk assessment must be performed to identify effective controls for any soil accumulation that may occur.
Vertical elements must be:
 Of steel or reinforced concrete without accessible routs for passage of contaminants or pests, and oriented
to minimize accumulation of dirt and debris.
 Built flush with or encased in adjacent walls to reduce residue collection. If not built into the walls a gap
of at least 20 cm / 8 inches must be provided between framing and walls to allow for access and inspection.
 Freestanding vertical members in medium and high hygiene areas must be encased in reinforced concrete to a
height of at least 60 cm / 24 inches. The tops must be sloped to minimize dust collections (see Figure 13 -
Vertical Columns for Medium and High Hygiene Areas.

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Figure 12 - Unhygienic and hygienic steel structures.

Requirements for Building Fabric

Figure 13 - Vertical Columns for Medium and High Hygiene Areas.

7.4. Roofs (Principle 8)

7.4.1. General Requirements
Roof must provide a barrier
against infiltration of water, pests, and any other contaminates, be
waterproof and easily cleanable. Too that end roofs must:
 Be designed to be freely draining including emergency drains and drain heating
elements when necessary for cold climates. See BS EN12056 part 3
 Be hermetically sealed under all weather conditions. Formation of condensate on the
inside of the roof must be prevented by adequate ventilation.
 Be designed with a minimum number of roof openings (vents, air intakes, exhausts). Intakes must be properly
sealed/flashed against the elements (rain), debris and pets.

Figure 14 - Example detail for well flashed roof opening

 Provide for sanitary access for inspection, cleaning and maintenance. Access to
the roof must be from the outside of the building. If it is necessary to access the roof from the inside of the
buildings appropriate hygienic transition areas must be provided.
 Allow for uncluttered installations of utilities external to the building envelop
 Not include protruding ledges or architectural elements which may attract birds.
 Minimize overhang. Where necessary roof overhangs must be sealed to prevent roosting and nesting of birds.
 Roof membranes must be white, smooth and easily cleanable. Membranes must be
thick enough to prevent cuts and tears from normal use. Load spreading covers must be applied to common
rooftop walkways.
 Gravel or rock ballast roofs are prohibited.

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Figure 15 - Easily cleanable white roof membrane (left) and properly installed roof hatch (right)

7.4.2. Roof Drainage

 Roofs must be sloped a minimum of 1-2% (10mm/m | ¼” / ft) to ensure positive drainage.
 For flat roofs, water must be transported by channels on the roof over the hygienic areas and then lead
into a gravity or siphon drainage system outside the hygienic area.
 For flat roofs downspouts must be present. Downspouts must be equipped with bullet-nosed grates to
Requirements for Building Fabric

prevent blocking and fitted with means to prevent rodent intrusion (e.g. drain traps, expansion sections or
screens/grates)
 Downspouts must run external to the building envelope, if not possible they must run outside the
hygienic areas. If run internally downspouts must include methods to prevent condensation from forming.
 Horizontal roof drainage piping must be kept away from food processing areas.

Figure 16 - Hygienic Roof Drainage of a ridge and valley roof utilizing external downspouts

Figure 17 - 'Rat stop' device for preventing rodent roof access through downspouts

7.4.3. External Canopies

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Any external canopies or overhangs must be completely enclosed to prevent bird access
for roosting.

Figure 18 - Hygienic canopy design.

7.5. Floors - (Infrastructure Principle 4)

7.5.1. General Requirements
Floor surfaces must be designed to meet the specific hygienic zone, method of cleaning and type of product
Requirements for Building Fabric

manufactured, packed or stored in each area, room or section of the room.

Floors must be solid and smooth.
Floors and floor coatings must be free from loose scale, pits, cracks, crevices, erosions, voids or other imperfections.
Floors shall be free from deep stamping or embossing that could harbor dust, debris, insects, microbes.
Floors must be capable of being easily cleaned via methods appropriate for the area’s hygienic designation.
Exposed edges of floors must be supported by stainless steel angles.
Where possible floors must be light in color to facilitate ease of cleaning and inspection.
Bituminous (asphalt) flooring shall not be used.

7.5.2. Floor Coatings and Materials

Floor coatings must be durable under conditions of use including:
 Mechanical abrasion and impact (e.g. forklift and pallet jack traffic)
 Chemical hazards (e.g. strong acids or alkali, fats/oils, sugar solutions)
 Thermal shock
 pH tolerance
 Expected soil types and cleaning chemistry must also be considered:
 Oils and fats: vegetable oils for example can degrade some resin systems. When vegetable oils and animal
fats oxidize, they can form organic acids.
 Organic acids: many animal and vegetable products are naturally acid. Spirit vinegar is widely used in
cleaning and is very aggressive.
 Mineral acids: nitric acid and phosphoric acid are widely used for cleaning purposes.
 Alkalis: sodium hydroxide (caustic soda) is widely used for cleaning. In CIP areas it can be particularly
aggressive due to the strength and temperature of the solutions employed.
 Solvents: alcohol is also used for disinfecting. Some essences, for example peppermint oil, can behave
like solvents and be very aggressive.
 Disinfectants: sodium hypochlorite, peracetic acid, hydrogen peroxide as well as organic disinfectants can be
very aggressive, particularly undiluted solutions.
 Salts: salt solutions do not normally damage floors unless at high temperatures.
 Sugars: strong solutions at high temperatures can be very aggressive due to their high specific heat
capacity resulting in extreme thermal shock.

Vitrified Tiles and Acid Brick Systems

Where vitrified tile or brick systems are installed tiles/bricks must:
 Have sufficient thickness to resist applied loads (i.e. forklift traffic)
 Be installed in a way that minimizes edge lipping
 Be installed using a grout material suitable for the processing environment, typically epoxy resins or
vinyl esters. Grout must be installed level with the top of the tiles.
 Joints between tiles must be as small as possible (<3mm / 0.1”) preferably using vibrational installation with
butt joints.

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Figure 19 - Hexagon Acid Tiles Under Valve Cluster - From Kagetec-Industrial Flooring (link)
Requirements for Building Fabric

Figure 20 - Installation of Vitrified Ceramic or Acid Brick Tiles – From Kagetec-Industrial Flooring

Monolithic Resinous Flooring Systems

Epoxy systems – have limited chemical and thermal resistance but reasonable mechanical strength. Generally
appropriate in environments that are completely dry with light or medium duty loads,
including some warehouse activity.

Figure 21 - Epoxy flooring system (from Stonhard)

Polyurethane systems – durability varies substantially with thickness. Thicker layers are generally stronger. Polyurethane floor
has significant flexibility, good thermal shock resistance, and good resistance to common food manufacturing chemistry.

Generally, work well in permanently wet environments. Suitable for use as process
floors in medium and heavy-duty environments.

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Figure 22 - Urethane mortar system (from StonHard).

Requirements for Building Fabric

Figure 23 - Well installed resinous monolithic floor

Figure 24 - Resinous Monolithic Floor

7.5.3. – Resinous Flooring System Pitfalls

Resinous flooring
Must be apply must be installed at thicknesses of 0.375 inches (375 mils or 3/8”) or greater. .
systems will rapidly fail in areas subjected to thermal shock. Sugar acid damage to
floors.

Delaminating Floor 1

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Table 6 - A guide to the physical properties of some common floor finishes. Adapted from EHEDG Guideline 44 – Hygienic Principles for Food Factories. This table is a guide only. Within each resin system the properties
can vary significantly according to the formulation. Some epoxy and polyurethane floors may require extended curing times before entering service. The floor performance in resin systems generally depends on total floor
buildup. The performance of tile floors in wet areas is highly dependent upon joint width. Compressive strength given here is only an indication of resilience under heavy static loads, but is a poor indicator of durability of
composite materials under dynamic loads, e.g. forklift traffic

Polymer
modified Polymethyl-
Powerfloated cementitious Epoxy resin Polyurethane methacrylate
Concrete floors floors floors floors Heavy duty Polyurethane floors floors Tile floors
Requirements for Building Fabric

Dry pressed Fully vitrified Fully vitrified

<4 mm 4-6 mm 9-12 mm Extruded tile clinker tile porcelain tile porcelain tile
thickness thickness thickness floors floors floors floors

18-22 mm 15-20 mm 12-15 mm 18 mm

thickness thickness thickness thickness
Compressive
40 30-70 50-100 30-55 30-55 30-55 30-90 >100 250 >150 >150
Strength N/mm

Flexibility Low Low Low High Medium Medium Medium Low Low Low Low

Acid resistance Low Low Medium/Low Medium High High Medium High High High High

Alkali resistance Low Medium Medium Medium High High Medium High High High High

Solvent Resistance Medium Medium Medium Medium High High Low High High High High

Wet environment Intermittent Intermittent

Poor Poor Moderate Good Poor Poor Moderate Good Good
suitability only. only
Depends on
Yes Yes Medium Yellowing Yellowing Yes Yes Yes Yes Yes
UV Color Stability specification
Application
>5°C >5°C >5°C 0-30°C 0-30°C 0-30°C >-30°C >5°C >5°C >5°C >5°C
temperature
Maximum Service
>90°C <70°C <70°C <60°C <70°C 90-130°C <60°C >90°C >90°C >90°C >90°C
Temperature
Time to put into
28 days 3-21 days 6-48 hours 8-24 hours 8-24 hours 8-24 hours 1 hour 24 hours 24 hours 24 hours 24 hours
service (at 20°C)
Typical Uses Areas Basic Hygiene Basic and 6-10 mm for dry Basic and Dry Basic, medium, Medium and Medium and Dry medium Dry medium Medium and Medium and
Areas, medium medium medium/high and high high hygiene, high hygiene hygiene areas, hygiene areas, high hygiene high hygiene,
Mechanical/plant hygiene areas, hygiene areas, hygiene areas hygiene areas, wet or dry, dry areas cooking, heavy cooking, heavy areas, low thermal shock /
rooms, storage, 2-4 mm for light with light to <70°C, light to heavy duty <60°C. Making traffic. traffic. duty. chemical
workshops, oven engineering duty finished medium duty. medium duty. areas. repairs. attack, CIP
plinths workshops product areas rooms, heavy
traffic areas.

Classified as General Business

 Global Sanitation Hygienic Design Handbook — Infrastructure

7.5.4. Slope/Fall
Wet Controlled Wet Dry

 Floors must be free draining and  Floors in wet areas must be free  Floors must be
appropriately sloped to drains. draining and appropriately sloped to free draining and
 1.5% Slope (15 mm/m or 3/16”/ft) drains. appropriately
is generally sufficient to provide  1.5% Slope (15 mm/m or 3/8”/ft) is sloped to drains.
free draining. generally sufficient to provide free  For completely dry
 For consistently wet areas slope draining. areas floors must
must be up to 2% (20 mm/m or  For chronically wet area’s slope generally be flat
¼”/ft). must be up to 2% (20 mm/m or <1% (< 10mm/m
 In especially greasy areas floors ¼”/ft). or 1/8”/ft)
with steeper slopes will require  In especially greasy areas floors
more slip resistance to ensure with steeper slopes will require
worker safety. more slip resistance to ensure
worker safety.

7.5.5. Flooring Joints

Joins must be positioned away from areas
All Joints are weak points and will become maintenance items.
subject to regular discharge of liquids and in locations where they are accessible for
inspection and maintenance.
Joints must be designed to accommodate expected movements, with width and depth of the joint designed accordingly.
Requirements for Building Fabric

Figure 25 - Good movement joint detail without edge protection – appropriate for light traffic areas

Figure 26 - Good movement joint detail with steel edge protection – appropriate for normal traffic areas

7.6. Process Drains - (Infrastructure Principle 4 and 7)

7.6.1. General Requirements
 Sewage and waste disposal system must be design and constructed to prevent cross-contamination to he
potable water [Link] or sewage pipes must not be located or pass
directly above product contact surfaces.
 Drains must be provided in sufficient number, and correctly located, to prevent
standing water, generally 1 drain for every 1,000 ft2 or 92 m2. Floors must slope to
the drain - either across whole area or as 'diamond' around the drain. Areas to be drained must not exceed
35 m2 / 400 ft2 per drain.
 Facility design must prevent water migration/intrusion between wet and dry areas,
and different hygienic zones.
 Drain flow must be from the Highest
Hygienic Zone to the Lowes Hygienic Zone, or
from RTE to RAW. Critical Care Zones drainage must be separated from
other drain systems whenever possible.

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 Drains must be located as close as possible to the sources of the effluents. Direct equipment
discharge to the floors must be avoided. Where drainage is required from machinery
splashing can be minimized using funnels or tundish drains above the drain body which provide an air gap
between the drain and the machine water outlet. Air gap must be at least 1.5 x the ID of the drainage pipe
(See Figure 27).
 Water drainage path must avoid crossing traffic ways of personnel and goods.
 In processing area, where large amounts of solid material is on the floor (ie. in vegetable processing areas) -
the particles must be retained by the removable grating/ strainer before passing the siphon.
 Drains must be easily accessible (not under equipment). In wet processing areas,
drain lines can be at right angles to the process/product flow - which allows for flexibility of change of
equipment position, whilst keeping accessibility.
 Trench/Channel drains must be avoided wherever possible. See trench section of this chapter
 Drains must be designed to prevent backflow of any drained liquids and
odors or gasses from entering process.
 Traps/Siphons must be maintained full of water (or water and disinfectant) - to prevent backflow of
aerosols and odors into processing and/or packaging areas.
 Design of the drain must be chosen as a direct function of the amount of
liquid to be evacuated. Drain diameter must be dimensioned according to the amount of water being
drained, but not be less than 100mm.
 Washrooms / Cleaning Rooms, (COP rooms/Cleaning rooms) must have at least one floor drain
with the floor sloped to the drain.
 A detailed floorplan drawing of the facility showing the location of drains and the routing of drain lines must be
provided.
Requirements for Building Fabric

Figure 27 - Equipment Drain with and Without Adequate Air Gap

 It is possible to design the air gap into the funnel mechanism to minimize splashing (see Figure 28 - Drain
funnel with overflow prevention slot.

Figure 28 - Drain funnel with overflow prevention slot.

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7.6.2. Sizing and Location

The number and location of drains are based on the configuration of the floor plan, type of
operation and location of equipment. Location and number of floor drains required can be determined only after careful review
of the plans and anticipated building
use. Floor drains or area drains, when used to drain exterior areas, must have an open area equal to twice the transverse area
of the connecting pipe.

Table 7 - Recommended Grate Free Areas for Various Outlet Pipe Sizes

Nominal Transverse Area Minimum Floor Minimum Floor Requirements

Size Pipe of Pipe Requirements (interior areas) (Exterior areas)
Measure
Square Inch 1.50 2.04 3.06 4.08
Square centimeter 9.68 13.16 19.74 26.32
Square Inch 2.00 3.14 4.71 6.28
Square centimeter 12.90 20.26 30.39 40.52
Square Inch 3.00 7.06 10.59 14.12
Square centimeter 19.35 45.55 68.32 91.10
Square Inch 4.00 12.60 18.90 25.20
Square centimeter 25.81 81.29 121.94 162.58
Square Inch 5.00 19.60 29.40 39.20
Square centimeter 32.26 126.45 189.68 252.90
Square Inch 6.00 28.30 42.45 56.60
Square centimeter 38.71 182.58 273.87 365.16
Requirements for Building Fabric

Square Inch 8.00 50.25 75.38 100.50

Square centimeter 51.61 324.19 486.32 648.39

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7.6.3. Trench Drains

Trench drains must not be used unless no other options exist. When trench drains must be used the sanitary conditions
of a trench drain system must be evaluated at every location to minimize bacterial growth and cross-contamination. Trench
drain systems must be used only when no other alternative is available for your type of process. E.g., heavy soils and high
volumes of water need to be evacuated fast. Like in a slaughter live dock evisceration processes or brewery.
 The bottom of each trench drain must slope at least one eight inch per foot or .3cm per every 30cm.
 Cover plates must be cleanable and fitted over the trenches and remain in place during operations.
Trench drains must be eliminated in areas where RF-RTE foods are processed or
exposed, or when this is not possible, equipped for automatic flushing.
Must be:
 PRINCIPLE #1 - CLEANABLE TO A MICROBIOLOGICAL LEVEL
 PRINCIPLE #2 - MADE OF COMPATIBLE MATERIALS
 PRINCIPLE #3 - ACCESSIBLE FOR INSPECTION, MAINTENANCE, & CLEANING/SANITATION
 PRINCIPLE #4 - NO LIQUID OR PRODUCT COLLECTION
 PRINCIPLE #5 - HOLLOW AREAS HERMETICALLY SEALED
 PRINCIPLE #6 - NO NICHES
 PRINCIPLE #7 - SANITARY OPERATIONAL PERFORMANCE
 PRINCIPLE #8 - HYGIENIC DESIGN OF MAINTENANCE ENCLOSURES
 PRINCIPLE #9 - HYGIENIC COMPATIBILITY WITH OTHER SYSTEMS
 PRINCIPLE #10 - VALIDATED SSOP & PROCESS CONTROLS VALIDATION
See also section 5.6.6. for more information about trench drains

Slopped with no liquid

Cleanable cover collection
Requirements for Building Fabric

Edge filled

INTERNAL RADI
larger than 3mm

One piece
hygienically design

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Traditional trench drains also require more work when it comes to cleaning and
sanitation. After removing and cleaning the grate, the channel needs to be taken out to be thoroughly scrubbed and
sanitized at the end of each day (only in the food industry). As an alternative, and based on risk
assessment, Slot Drain may be considered, since they can be self-cleaning or manually
cleaned, simply needs a special paddle to push waste through the channel before
sanitizing it.

Slot Drain Easy cleaning

with specialized
tools

Easy cleaning with specialized

tools
Requirements for Building Fabric

7.6.4. Requirements by cleaning method.

Table 8 - Requirements for drains by cleaning method.

Wet Controlled Wet Dry

 Channels and gullies must have  In controlled wet cleaning areas  In dry cleaned areas gullies and
gratings of a high hygienic standard. channels must be avoided. channels must be avoided. If drainage is
 The floor must have an adequate  Gullies must be sealed and gas tight unavoidable, it must be a sealed, gas
slope towards drain. with a smooth surface which can be tight system with a smooth surface which
 Drains must be placed away from opened by a vacuum handle for can be opened by a vacuum handle for
hygienic production areas but close access and disinfection. access or disinfection.
enough to allow efficient drainage of  For additional protection against  For additional protection against possible
liquids. possible aerosols release from the aerosol release from drains, a special
 Drain body (pan) must be of one piece drain a special trap preventing trap preventing overpressure in the
or connected via sanitary welding, overpressure in the connected connected drainage piping can be
with rounded corners easy to clean, drainage piping can be installed. installed. Drains that are used only
inspect and swab.  Be vented to the exterior of the occasionally must be placed as far away
 Must be of high retention and high premises. from hygienic production as possible.
flow rate.  Ensure waste trap or screening
 Linear channels must preferably be systems are located away from any
kept shallow and ideally placed along food handling area or entrance to the
a wall. premises.
 Approximately one 4” or 10 cm drain
outlet with deep seal trap vented to
prevent sewer gases from entering the
facility.
 Removable and flush fitting grating.
 Able to handle high flows.
 Be vented to the exterior of the
premises.
 Ensure waste trap or screening
systems are located away from any
food handling area or entrance to the
premises.

7.6.5. Drain Routing

 Sanitary/Foul Sewers must not be routed through food processing or storage areas.
 Sanitary/Foul Sewers must not be cross connected within the building.
 Where possible stormwater and/or roof drainage must not be routed through or under process areas.
 Process drains must not be connected to storm water system.
 Drainage must flow from High to Medium Hygienic zones. Where possible High hygiene areas must be run
separately until external connection with the sewer.
 Where possible, drains in critical areas must be run to remote sumps to avoid the need for p-traps.
 Where possible drain cleanouts for rodding/jetting must be located outside of food processing areas (see
Figure 29).
 Smooth turns and swept bends must be used whenever possible to simplify drain cleaning (see Figure 30).
 Air (gas) discharges from sewage lines, drain lines, and raw process areas are not vented in a manner that
may contaminate air intakes.

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 Sewage, drain lines, and air discharges from raw process areas are vented at least twelve inches below the
level of fresh air intakes when located within 50 feet of each other (as these gases are typically heavier than
air)

Figure 29 - Ideal Layout of drainage flow

Requirements for Building Fabric

Figure 30 - Example drain installation with swept bends and connections. Note that collection area is located outside of the
hygienic area.

7.6.6. Drain Design and Installation

Drains must be made of materials resistant to corrosion under conditions of use.
Stainless must be used for drains construction.
 Drain piping must have smooth interior surface and be adequate to resist expected discharge temperature,
pH, or corrosivity. Stainless steel must always be used in critical applications.
 Where possible drains must be installed in areas that eliminate the need for traffic over drains. Where drains
are in areas with access to production traffic (i.e. forklifts), the drains must be able to resist applied loads and
turning stresses. Fastening the drain gully or channel to the floor will be especially critical to prevent cracking
and subsequent microbial harborage.
 Drains must be designed with an easily removable sediment basket to prevent solids from entering the drain
and possibly causing blockage.

Figure 31- Sanitary Drain Baskets

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Figure 32 - Hygienic round drain with locakble secondary strainer to prevent solids from entering drain lines.
[Link]

 Drain gullies must have a round body, must be completely able to drain and designed without lips or crevices
that will allow soil to accumulate. Frame must be designed to fit specific flooring material used in the area,
e.g. tile or resin monolithic system.
Requirements for Building Fabric

Figure 33 - Hygienic square and round spot/gully drains

 Drains must have perforated covers, which can easily be removed for cleaning.
 Contact of the drain element to the floors needs special attention to avoid a residue collecting point and sub-
floor seepage.
 Condensate drain lines are insulated & jacketed in areas where surface condensation may form on the
piping, & are heated in areas subject to freezing
 Trench or channel drains must be avoided whenever possible. When channel drains are necessary
(e.g. high discharge flow from CIP cleaning cycles), they must:
o Be present a maximum of 6 m / 20 ft from the wall, the distance between two trench drains is
maximum 12 m / 40 ft. The slope of the floor must be in the direction of the drains.
o Be covered with a strong, open, and removable metal grating rugged enough to withstand heavy
forklift traffic. Grating sections must be no longer than 100 cm / 36” and preferably no longer than
50 cm / 18”. Design of the grating and grating support must be easily cleaned.
o The grating must rest on ridges or buttons fixed to the grating to allow quick draining of liquids, the
rods must not be fixed in the drain wall.
o The gratings must be set 3 mm above the surrounding floor level to minimize damage to the edges
of the gutter
o Have a lateral slope towards the outlet of the channel. Slope must be a minimum of 1%, preferably
more.

Figure 34 - Channel drain showing slope to outlet.

o Have a “V” or “U” shape to facilitate cleaning and prevent areas of soil accumulation.

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Figure 35 - Channel drain showing 'V' and 'U' cross sections.

o Must be installed so that visible joints with the floor are rigid and adequately sealed to the surrounding floor to
prevent water intrusion and harborage. Special care must be given when attaching drain channels to resin
flooring systems.
o Must have access for manual cleaning and allow for complete visible inspection. Narrow slot drains must be
avoided.
Requirements for Building Fabric

Figure 36 - Well installed channel drain

 Trench or channel drains must not be formed using flooring materials. Such designs are not long-lasting
hygienic solutions.

Figure 37 - Channel formed using flooring material showing degradation of tiles.

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7.7. Walls - (Infrastructure Principle 4 and 8)

7.7.1. General Requirements
Walls must be impervious, smooth, cleanable, durable under conditions of use, have
minimal joints and no cavities.
When walls must be insulated, insulation material must not deteriorate, retain or absorb moisture such as closed cell or
encapsulated foams.
Fiberglass or rock wool insulation must not be used in food processing, storage or
handing environments.
Walls for refrigerated areas must have a vapor barrier to prevent migration of moisture into the insulation.
Walls must not have cold bridges/thermal shorts.

7.7.2. External Walls

 Exterior walls must be weather, water, insect, and rodent proof.
 Exterior walls must not have horizontal surfaces (gradients ≥ 45°) to prevent soil accumulation and pest
harborage (see Figure 38).
Requirements for Building Fabric

Figure 38 - Horizontal ledges on exterior walls

 Exterior walls shall be insulated or otherwise constructed to prevent

condensation on interior surfaces. Insulation, if used on interior surfaces must be impervious
and inert material which will not support microbial growth.
 Joints in exterior walls must be adequately sealed from roof to footing.
 Precast and/or tilt up concrete exterior wall panels with pocket beam construction are considered sanitary
These panels shall be ordered with no foam insulation exposed.
construction.
These wall and ceiling panels, double tee ceiling panels and any columns
must be sealed to prevent dusting and the absorption of moisture.
 Preferred walls are either cement block, tilt up, precast or poured concrete. Cement in any of the four forms
mentioned is preferred. The cement block wall is erected by courses inside a steel framework. These must be
waterproofed and made of dense concrete. Never use cinder block as it is porous and will allow moisture to
seep in. Tilt up, precast or poured walls are used for many of the larger plants being built today. Poured
concrete walls should be troweled smooth to a standard of no more than one inch (3 mm) hole per square
foot (.09 sq.m).8
 Poured concrete walls do not have the seams that require caulking that are found in precast or tilt up
construction. However, poured concrete is more expensive and requires on-site construction of forms and
finishing. Precast or tilt up walls have proven to be a rapid and economical way of
erecting a food processing plant. Their main disadvantages are the time and
expense necessary to adequately caulk all the joints and seams between
panels. The caulking must be periodically maintained. Precast walls are now successfully using notched
beams, notched precast wall panels and double-tee precast roof panels for food processing plants. The
technique entails pre-casting the wall panels and the roof support beams complete with notches large enough
to accommodate the precast double tees on the roof panels. When lifted into place the double tee fits into the
notches rather than resting on top of the beams or walls. By fitting inside the notch, the dust-collecting fl at
surfaces on top of the beams or wall panels that are usually associated with this type of construction are
eliminated. It is then a simple matter to fill and caulk the spaces around the double tees creating a
commercially sanitary structure.
7.7.3. Interior walls
 Interior wall must be:
o Light colored, dense, tough, impact resistant, durable, rust proof and dust proof, impervious, non-
absorbent, washable, water repellent and constructed of non-hazardous materials.
o Resistant to microorganism (particularly mould growth), rodents and insects
o Smooth and cleanable, free from cracks and cavities, and have minimal joints. Any joints must be
sealed with an impermeable sealant unable to absorb grease or food particles or provide harborage
for pests
 Concrete surfaces are free of pits, erosions & voids, solid & smooth
 Caulking must be minimized & done in a quality manner.

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 Walls or applied wall coatings must be able to withstand cleaning chemicals and methods used. Wherever
possible the use of paint must be avoided in processing areas.
 In WET areas walls must not be painted
 All vertical surface to floor junctions must be free of pits, erosion & voids.
 Joints at the wall to wall and wall to ceiling junctions and corners must be rounded or coved and all Joints and
edges must be sealed, tight fitting and waterproof with no cracks or crevices that may provide access for
pests and vermin.

Figure 39 - Wall coving and connection joints.

Requirements for Building Fabric

 Control and expansion joints in concrete walls or concrete stub walls must be aligned with similar joints in
floors and foundations where possible.
 Prefabricated Insulated Metal Panel (IMP) walls must be placed on a curb or stub wall to protect them from
impact, stub walls must be chamfered to prevent dust accumulation and be properly sealed to the panel (see
section 7.9.2).

Figure 40 - Insulated Metal Panel Wall Cross Section

 The use of gypsum ( soft sulfate mineral composed of calcium sulfate dihydrate) material is not acceptable for
process areas.
 The use of hollow walls is prohibited in food processing, packaging, and storage areas.
 Openings to over-pressured high hygiene areas must be closed

7.8. Penetrations
Plant walls will, at one time or another, require penetrations for access by utilities or for other reasons. These penetrations must
be planned well ahead of time and the timing coordinated with the utility or other services being taken through the
wall. Once the penetration is made, it must be used and sealed the same day. Leaving it open overnight may result in
microbiological, physical, or chemical contamination introduction, such as pests invading the wall, which, if it has an exposed
insulated or hollow core, will provide them an excellent home.

7.8.1. Penetration Components

BARRIER
A structural barrier of some type through which a hole is cut to allow a penetrant (such as a pipe or tube) to pass through. Some
common examples in the processing environment: Walls, Ceilings, Floors, Electrical panels and enclosures, Mechanical control
panels, Jacketed tanks, or vessels.

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PENETRANT
The object that runs uninterrupted through the hole in the barrier, from one side to the other. This includes
 Process piping and tubing
 Electrical conduit
 Tube-in-tube floor transitions
 Electrical wire and cable
 Hydraulic hoses
 Refrigeration pipe and tubing
 Structural supports and plastic drains or vents
Requirements for Building Fabric

EALING DEVICE
The element that blocks the open area around the penetrant to seal off one side of the barrier from the other. Examples include:

 Temporary seals like putties, sealants or caulks

 Older, more traditional solutions like metal escutcheon wall plates
 Modular mechanical systems
 Newer technologies such as flexible boots

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7.9. Coving, Curbs, Posts/Bollards, and Other barriers - (Infrastructure Principle

4 and 6)
7.9.1. Coving
Floor to wall junctions must be coved to minimize soil accumulation and simplify
cleaning. Cove must be at least 100 mm / 4 inch radius or 50 mm / 2” chamfer (see Figure 41). Coving can be
formed using:
 Resin floor finish
 Polymer composite
 Prefabricated skirtings
 Coving tiles (offices and restrooms only)
 Stainless steel (not preferred for cost/maintenance reasons).

Floor covings must:

 Prevent accumulation of soil and promote easy cleaning
 Prevent water ingress into the wall
 Ensure effective separation of adjacent processing areas.
Requirements for Building Fabric

Figure 41 - Coved floor to wall junctions

Figure 42 – Coved polyurethane floor to wall junction (left) and stainless-steel cove and curb cladding (right).

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7.9.2. Curbs
Walls and doors must be protected from impact and damage from mobile equipment, e.g. forklifts, pallet jacks, carts, trolleys,
bines, etc. A
traffic pattern analysis must be performed to identify the level of protection
required; higher traffic areas will require more protection than lower traffic areas.
 When curbs are used to protect walls, they must be high enough to prevent damage by heavy transport e.g.
from palette or forklift traffic. Curb walls must be at least 45cm / 18” high.
 Curb walls 60cm / 24” high are recommended in most cases, with taller stub walls used as necessary in high
impact or heavy wet wash areas.
 Curb walls must have a coved base (see above)
 Curb walls must have a chamfered to prevent dust and soil accumulation.
 Curb walls must be smooth, easy to clean, and resistant to corrosion and chemical resistant. If a protective
coating is applied, it must adhere well to the substrate. Curb and floor must be compatible or identical when
appropriate.
Requirements for Building Fabric

Figure 43 – Installation detail of pour in place concrete curb wall (left) and closeup of urethane coated stub wall with properly
chamfered top (right).

Figure 44 - Reinforced concrete curb for floor openings without stainless steel sleeve (left) and with stainless steel sleeve and
handrail (right).

7.9.3. Posts, bollards, and similar barriers

Walls, doors and other structures such as columns, external wall corners, and machinery must be protected from impact
damage, e.g. forklift traffic, carts, etc.
Bollards and crash bars must be large enough to resist expected impact loads. Minimum recommended size is 100mm / 4”
diameter.
Bollards must be impervious and corrosion resistant under conditions of use. Stainless steel must be used in any wet or
controlled wet cleaning environments. Galvanized or painted mild steel must only be used in completely dry areas (e.g.
warehouses).
It is recommended that bollards be filled with concrete or resin for increased strength and to prevent pest harborage.
Wherever possible bollards must be core drilled through the floor and set with non-shrink grout.

Figure 45 - Bollard installation detail (left), Installed Stainless Steel Bollard (right).

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7.10. Doors - (Infrastructure Principle 6 and 8)

7.10.1. General Requirements
 Door surfaces must be completely flat and smooth to minimize dust accumulation.
 Doorframes must not be constructed from wood or hollow square profiles. Wood is not suitable as it is
vulnerable to rodent attack.
 Interfacing of doorframes with walls and floors must be smooth and contain no cracks or holes were dirt and
insects can exist.

Figure 46 – Plan cutaway detail for doorframe openings.

Requirements for Building Fabric

Doors must be:

 Self-closing and equipped with kick plates and push plates.
 Light colored and cleanable
 Dense, tough, impact resisting, durable, rust proof and dust proof
 Impervious, non-absorbent, washable, water repellent and constructed of non-hazardous materials
 Smooth and free from cracks and have any joints sealed with an impermeable sealant
 Unable to absorb grease or food particles or provide harborage for pests resistant to microorganism
(particularly mould growth), rodents and insects.
 Doors must be able to withstand cleaning chemicals and methods used
 Tight fitting frames and lack of gaps at floor-to-door contact will be necessary. Maximum clearance of less
than 6 mm is needed.
 When door stoppers are necessary, they should be mounted to the walls rather than to the floor.

Figure 47 - Wall mounted door stop

7.10.2. Exterior doors

Exterior door must:
 Be primary barriers to infestation and ingress of dust etc.
 Not open directly into production areas (high and medium care zones.
 Be self-closing to keep out rodents, birds and insects.
 Be reinforced with a 0.6 mm metal plate up to 1 m from the ground

Exterior doors used at night must have lighting located 9 – 12 m / 30-40 ft away to minimize insect attraction (see 5.3.3 - Site
Lighting). Follow all local regulations.
Exterior doors for traffic entry must be rapid closing doors, e.g. roller shutter doors or sliding doors. They must be self-closing
and fit closely at the base with a rubber strip or similar weather stripping.
Exterior doors for personnel entry must be constructed as double doors with an internal
lobby and a self-closing door.
External doors must be protected by a well dimensioned rain-roof, so that no water will drip from door seals when the door is
opened.

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 External emergency doors should not have a handle or be able to open from the outside.
 External doors should have canopies, to reduce possibility of water ingress in case of heavy rain.
 All emergency doors should have panic bars and be alarmed, this applies to internal doors between different
zones and external emergency doors. These doors should only be opened one way.

7.10.3. Interior Doors

Interior doors must provide adequate separation between different processing areas and
areas with different hygienic zones. In medium, high, or critical care zones doors must be solid (e.g. fiberglass
resin) or formed from a single sheet of 15mm / 5/8” PE or transparent PVC.

In refrigerated or cooled areas, insulated doors must be fully enclosed and must be covered with fully welded metal cladding,
and fully filled with PO-foam to prevent hazards caused by condensation. The
construction of the door must
not have any thermal bridges, to prevent condensation on the 'warm side' at bolts, door
locks and hinges.
Requirements for Building Fabric

Figure 48 - Fiberglass solid doors

7.10.4. High care, critical care, and microbiologically controlled areas

 All doors must be made of FRP, metal, stainless steel or aluminum.
 Door construction must be open, accessible and cleanable.
 All surfaces must be fully drainable and sloped.
 Vertical opening roller shutter doors must NOT be used. Debris from the bottom of the door seal (potentially
containing pathogens) may drip into product/packaging, ingredients, etc. during transportation.
 High speed double leaf sliding doors, which open sideways, must be used.

Figure 49 - High speed double leaf sliding door (left) and High hygiene rapid roll door (right).

 Brush stripes are not acceptable.

 All door operating systems, especially those containing lubricants, must be effectively sealed
 Door hatches for smoke ventilation, mounted in the inner roof of the building, must open out of the High
hygiene area.

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Figure 50 - Examples of sliding and roll up doors.

7.11. Airlock and Transition Rooms – (Infrastructure Principal 2, 5, 6)

7.11.1. Concept
An airlock is a transitional space that typically has two doors in series to separate a controlled environment (such as cleanroom,
lab, operating room, or isolation room) from a corridor, or vice versa. The two doors should be interlocked to avoid being
opened at the same time. An airlock area is often ventilated with filtered supply air, with return or exhaust air to exit. However,
the relative air volume for supply, return or exhaust could vary based on the type of airlock.

7.11.2. Purpose
Airlocks help implement heating, ventilation, and air conditioning (HVAC) control of air
classification or quality. It enables a shift or segregation between cleanliness levels or
different hygienic profiles, for example: from ISO 8 to ISO 7 or Grade C to B, or from High Care Zone to Critical
Care Zone.

An airlock segregates cleanliness zones.

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7.11.3. Functionality
Segregation is achieved by maintaining room pressurization (by the direction of air flow through doors) and isolating the levels
from each other.
While always designed for the higher level of cleanliness, when in use, the room will switch back and forth between levels as
the doors open and close. When one door is opened, the opposite door maintains the boundary. And when opened to the lower
classification level, the airlock effectively downgrades. Once all the doors are closed, the room re-establishes itself at the higher
level. Similarly, when a door is opened, air flows into or out of the room, and the pressurization at the open door goes neutral;
the door opposite becomes the new boundary
Transportation locks are primarily used as mechanisms for material entry into High Care areas or as small passages to allow
staff entry into High Care areas, where the use of barrier changing facilities is not appropriate. Transportation locks consist of
two doors one within the processing area and one within the High Care area. The doors may be interlocked so that only one
door can be opened at any one time.

7.11.4. General Requirements

 The overall construction of the interlock room must meet the design
requirements outlined in this Technical Standard, included but not limited to
walls, floors, ceilings, doors, drains (if any) etc.
 Pest Control Devices (Insectocutors) must be installed outside the airlock.
 Floor sloping towards the wet side - if the air lock connects a critical dry area to a wet area. The use of
drainage channels running across entrances can prevent the movement of water from wet areas into the air
lock.
 Drain may not be required in the zone with higher profile e.g. Critical Care, but there should be a drain on the
zone with lower risk profile (contaminated side).
 If the High Care area is not positively pressurized, the transport lock must be fitted with an air extractor so
that it is under negative pressure.
Requirements for Building Fabric

 Transport locks for personnel entry to a High Care area require:

o Shoe storage racks/lockers and shoe cleaning and sanitizing equipment
o Lockers or storage for smocks/overalls which need to reflect the total number of workers (shift
teams and day workers)
o Provision for visitors who will not have their own locker e.g. locker with disposable smock and
overshoes/ shoe covers
o Hand washing and drying facilities/equipment
See personnel and material airlock sections for more information

7.11.5. Air Pressure Requirements

High Care must maintain a pressure differential of 10-15 pascals between the
manufacturing area and the normal pressure of its surroundings. The Critical Care or
Aseptic environment of the manufacturing areas must be kept at an increased pressured to ensure the air flows from the
aseptic to non-aseptic area. The HVAC system is responsible for creating this increased pressure.
This pressure difference is important as it helps prevent cross-contamination and cross-contact. The increased pressure
prevents the air containing this dust and any other contaminants reaching the sterile environment.
To maintain the positive pressures in the manufacturing areas and any adjacent corridors, positive airlock must activated
before entering such corridors to prevent loss of the higher pressure. As well as maintaining the pressure difference,
these airlocks also help prevent contaminated air from reaching sterile areas.

High Care High Care

Medium Care Medium Care

Figure 51 - Airlock pressure zone changes based on door opening. Airlocks segregate cleanliness in the zones. When one
door is open, the room becomes the level of the open door, and the opposite door becomes the new boundary, indicated by the
red dashed line.

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7.11.6. Personnel Airlocks

Transport locks for personnel entry to a High Care area require:
 Shoe storage racks/lockers and shoe sanitizing equipment
 Lockers or storage for smocks/overalls which need to reflect the total number of workers (shift teams and day
workers)
 Provision for visitors who will not have their own locker e.g. locker with disposable smock and overshoes/
shoe covers hand washing and drying facilities, Hand Washing and Disinfection equipment/stations

Trash Can/Bin

Hand Wash Sink

Clean Smocks Basic Care Zone Trash Can/Bin
Turnstile (One way Hi-
gate)
Donning + GMP + PPE
Shoe cleaner &
sanitizer 4
3
Exit - Only

Shoe Covers if 5 Site Approved

returning to Basic Shoe shelf
Care

Separation (See
One-way to change
2 Examples Below
Site Approved Shoes
Requirements for Building Fabric

1 Street - Shoe shelf

Emergency Exit Only

Non-GMP Zone

Figure 52 - Example of Personnel Airlock at facility main entrance.

Figure 53 - Example layout of personnel transition room.

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Figure 54 - Example Personnel transition AirlockFigure 55 - Example of swivel seat option for crossover bench. Ideally a short
(150mm / 6”) curb would be present to reduce the risk off accidental cross contamination while changing [Link] 56 –
Requirements for Building Fabric

Example of Stepover bench with shoe lockers

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7.11.7. Material Airlocks

If vehicles are required in High Care areas, they must be restricted to these areas and carriage of goods such as pallets must
be exchanged from a Medium hygiene vehicle in a designated area. The use of floor plinths or racks is recommended to
prevent vehicle transfer between zones.
Requirements for Building Fabric

Figure 57 - Material airlock with concrete plinth for pallets.

 Must consider people safe design of areas where the movement of both
people and vehicular traffic is necessary.
 Wooden pallets are not permitted in High Care areas.
 If something must be supplied in a High Care area it must be repacked or restacked e.g. packaging
 Material on a wooden pallet must be restacked on a plastic pallet in an intermediate zone or air lock and must
be stripped (removal of outer foil) just before entering an air lock.

7.12. Windows - (Infrastructure Principle 6 and 8)

Windows, including windows in external and internal walls, vision panels, windows in door etc., must:
 Prevent the accumulation of dirt, light colored and be easy to clean.
 Be constructed of toughened glass (laminated), or shatterproof plastic, and
protected against breakage, e.g. with a protective film.
 Be installed at least 1.2m or 4ft above floor level
 Be fitted with frames which are dense, tough, impact resisting, durable, rust proof, impervious, non-
absorbent, washable, water repellent, smooth, crevice free, constructed of non-toxic materials and able to
withstand cleaning chemicals and methods used. Window frames must not be made of wood.
 Be installed in close fitting frames which are fitted flush and continually sealed to the walls.
 Have no sills or horizontal ledges. If ledges are unavoidable, exterior and interior window sills must be sloped
at least 60° to prevent accumulation of debris
When windows are also used for ventilation, tight fitting, properly sized screens must be
in place to prevent the ingress of insects, screens must be:
 Removable for cleaning
 Reinforced with a 6 mesh, 1.0 mm gauge (diameter) stainless steel wire if less than 1 m from the floor to
prevent rodent access.
 Reinforced with a 19 mesh, 0.24 mm gauge stainless steel, nylon, or pvc coated fiberglass wire to keep out
insects.
 Openable windows must open outwards to allow for easy cleaning from the outside.
 Skylights must be clean, free from condensation and must not open.

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Figure 58 - Examples of hygienic windows and doors

7.13. Ceilings – (Infrastructure Principal 6 and 9)

A ceiling must be provided in all processing areas. Ceilings (or where there are no ceilings the interior surface of the roof) and
overhead fixtures (e.g. ducts, pipes, stairs and elevators) must be constructed and finished so as to prevent the accumulation
for dirt and to reduce condensation and the shedding of particles.
Ceilings must be:
 Light colored, cleanable and have a finish that has desirable light reflectance characteristics.
 Dense, tough, impact resisting, durable, rust proof, and dust proof
 Impervious, non-absorbent, washable, water repellent and constructed of non-toxic materials.
 Smooth and free from cracks and have any joints sealed with an impermeable sealant.
 Unable to absorb grease or food particles or provide harborage for pests.
 Resistant to microbial growth (particularly mold), rodents, and insects.
 Able to withstand cleaning chemicals and methods used.
 Built at a height of at least 3m / 10 ft to minimize condensation.
 Ceilings must not support any item or structure which contains inaccessible horizontal surfaces.
 The ceiling must seal off all structural room elements from the production area, where possible all utilities
must be run on the roof side of the ceiling to avoid horizontal piping in the production area.
 Junctures between the wall and ceiling must be rounded, sealed, and easily cleaned.

Figure 59 - Installation detail for IMP ceiling joint (left) and IMP Ceiling to wall joint (right).

 Ceilings must be constructed using IMP sandwich panels with smooth, impervious, and easily cleaned
surfaces.
 Smooth, unpainted, sealed concrete, including “double – T” panels are also acceptable, particularly in dry
cleaned environments.

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Figure 60 - "Double-T" concrete panel ceiling

 Double ceiling structures must not be applied since they accumulate dust and form hollow, inaccessible
cavities.
 Ceilings must be constructed as walk on type for maintenance and inspection. The minimum clearance to the
roof side must be 1.5 m /5 feet.
Requirements for Building Fabric

Figure 61 - Walk on celing and utility chase (Naas IE)

 Perforated or porous material must not be used for sound absorbing (noise reduction) ceilings as these
materials will accumulate dust.
 All ceiling throughputs for conveyors, vents, piping, etc. must be well sealed with sealant or a collar. All
throughputs must be vertical.
 Drywall or gypsum ceilings are prohibited.
 Corrugated metal must not be used as sealing metal. High heat transfer with these
materials create condensation issues and the joints are difficult to clean.
 Drop ceiling panels in metal frames shall be avoided except for front office
areas.
7.14. Stairs and Elevated Platforms – (Infrastructure Principal 4 and 6)
7.14.1. General Requirements
Stairs, walkways, and platforms include secondary steelwork.
 Avoid crevices, ledges and voids, which could harbor insects, food residues and dirt. Supporting and framing
member must be designed to eliminate as many free ledges as possible and do minimize accumulation of dirt
and dust.
 Where possible the use of hollow tube forms must be avoided. If hollow
structures are necessary, they must be seal welded and be frequently
inspected for cracking. Any holes drilled in solid members must be
sleeved.
 If square tubing is used it must be turned 45° to minimize flat surfaces.

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Figure 62 - Platform showing square tubing turned to reduce flat areas.

Requirements for Building Fabric

Figure 63 - Example detail drawing for platform support structure with square tubing turned 45° to reduce flat areas.
 If handrails are made from circular tube, they must be welded to the stanchions and any tube joints must also
be welded and ground flush. All open ends of tubes and any other holes must be sealed with a welded plate.
All welds must be continuous.
 Stair tread and decking material must have adequate slip resistance while retaining cleanability

Figure 64 - Cleanable deck surface materials - AlGrip (Left) and SlipNot (Right)

 Open grating tread is prohibited above exposed product, product contact

surfaces, packaging, or WIP.
 Staircases and platforms over product zones must be designed to prevent contamination of product zones by
any material that might drip, drop, drain, or otherwise be drawn into the product zone.

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7.14.2. Materials of Construction

Table 9 - Acceptable materials for construction of platforms, stairs and mezzanines.

Wet Controlled Wet Dry

Stainless steel 304-316 or similar Stainless steel Stainless steel
corrosion resistant alloys suitable for Galvanized Mild Steel Galvanized Mild Steel
the conditions of use. Painted Mild Steel (Risk assessment Carbon Steel
Class 1 (highly durable) required) Painted Mild Steel
Class 1 + Class 2 (moderate, Class 1 + Class 2 + Class 3
acceptable durability) (corrosion & chemical sensitive)
Stainless steel AISI 304(L), AISI 316(L)
Hastelloy B &amp; C Hard chromium plated steel Galvanized, carbon and painted steel
Titanium Nickel-plated steel Cast iron
Polyvinyl chloride (PVC) Nickel-plated brass Bronze and Brass
Teflon (PTFE) Nickel-plated Copper
Polypropylene (PP) Anodised aluminium Zinc
Polyethylene (LDPE, HDPE) Nickel Polycarbonate
Polyvinylidene fluoride (PVDF) Acrylonitrile butadiene styrene (ABS)
Polysulfone (PES) Polyamide (PA)
Polyetheretherketone (PEEK) Polyacetal plastics (POM)
Polystyrene (PS) Phenolic resins (PF)
Polymethylmetacrylate (PMMA) Ureum and melamine resins (UF, MF)
Epoxy resin Polyurethane rubber (PU)
Neoprene rubber Nitrile rubber (NBR)
Ethylene propylene diene monomer
Requirements for Building Fabric

(EPDM)-rubber

7.14.3. Stairs
Stairs must meet the following requirements:
 Must be easy to clean
 Must be self-draining (in wet cleaned areas)
 Have closed tread stairs supported by a single support post either attached to a base plate or preferably
embedded in concrete.
 Stairs must be encased to restrict movement of debris from footwear
 Stairways shall comply with all the local legislation regarding the size and height of the steps
 Handrails must be welded to the stanchions and any tube joints should also be welded and ground flush. In
concrete stairs cases the handrails shall be embedded onto de floor

Figure 65 - Stair detail showing single supporting post.

Figure 66 – Handrail embedded in concrete stairs (left) and fully enclosed stair treads (right)

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7.14.4. Platforms, Walkways, and Mezzanines

All parts of a walkway framework and platform must be designed and installed in a way that is easily accessible for inspection,
maintenance and cleaning.
Raised walkways and platforms over open processes that expose product to the environment must be avoided to restrict soil
and foreign material cross-contamination. When necessary they must be adequately enclosed to protect the product zones.

Figure 67 - Incorrect (left) and Correct (right) ways to design a platform or stair crossing over a product area

Raised platforms and walkways must be provided with a kick plate ≥ 150 mm / 6” high. Where possible the kick-plates and
If one-piece construction is not possible then kick
decking must be designed as one-piece construction.
Requirements for Building Fabric

plates must be continuously welded on both sides to prevent harborage.

Figure 68 - Example kick plate showing single piece and continuously welded construction.

Platforms shall be designed with sufficient structural support to prevent the walking surface from bending, warping, or otherwise
deforming under conditions of intended use.
If platforms are used in Wet areas, they must be provided with drains:
 Platforms must be designed to slope to the drain.
 Drain lines must be un-trapped and provided with at air gap at the discharge to the sewer/floor drain.
 Drain lines must be removable for ease of cleaning.

Figure 69 - Example Mezzanine

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7.15. Docks and Receiving Facilities – (Infrastructure Principal 2, 8 and 9)

7.15.1. General Requirements
All raw materials, ingredients, and shipping materials shall be received and stored in buildings of sanitary construction.
Receiving and shipping functions for raw materials and ingredients shallbe physically isolated from those for
finished goods, from storage, and from processing facilities by walls and motor operated
doors. Separate staging areas shall be provided for receiving and shipping and they shall also be physically isolated from
warehouses and processing.
Area drains shall be provided in staging area floors with one for every 400 square feet (132 m) of floor space. Floors shall be
sloped to the drain at a 1-2% grade. All drains must be trapped and accessible for cleaning. See Drains section of this
Technical Standard for more information.
Locking caps shall be provided for all unloading connections since this is a potential
entry point for product tampering and can affect plant security. Caps shall be chained to the pipe or
support to prevent their loss or misplacement.
Outside connection sites shall be paved with concrete and provided with adequate drains to permit clean-up of spills where it is
permissible to dispose of product in sewer systems or plant process wastewater treatment systems.
All unloading systems shall be equipped with prescribed in-line screens, filters, and/or magnetic traps or metal detectors to
sense or remove extraneous matter and evaluate supplier performance

7.15.2. Truck or rail docks

Truck driveways must be sloped away from the dock doors to prevent accumulation of water, dirt and any truck debris including
oil leaks.
Truck docking area shall be paved and sloped at a minimum of 2 percent grade away
from the dock. Storm water and where required, sanitary (red water) trench drains shall be provided.
Requirements for Building Fabric

Canopies may be provided to minimize risk of rain intrusion, but they must be completely sealed on the underside to prevent
bird and insect nesting. All exterior dock doors shall be equipped with properly fitted seals for trucks or railcars.
Vertically storing edge of dock levelers is recommended (see Figure 71). A continuous pit if front of all dock doors in a row is
preferred for ease of cleaning.

Figure 70 - Well designed truck receiving dock with rodent barrier, dock seals, and well-sealed canopy.

Figure 71 - Vertical Storage of Dock Levelers

Rodent barrier gates shall be installed on all ramps and stairs leading to docks. Gates and side panels are to be a minimum of
16 inches (40 cm) high above dock level and are to be constructed using a frame of structural tubing and a facing of solid sheet
metal. Side panels are to extend a minimum of 24 inches (60 cm) from side of gate.
All “cool” docks shall be maintained at or below 45°F (7º C).
Railroad tracks within buildings shall be confined to physically isolated receiving and shipping areas and are prohibited in
warehouses.
Any railroad tracks beds described in g shall be paved with concrete to eliminate all gravel or dirt within the confines of the
loading/unloading facility. These surfaces must be pitched at a 2% grade to a drain to prevent water from melting snow or
runoff water to pond or form puddles and become an attractant for insects and rodents.

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Storage bin openings and floor dump pits shall have a 4 inch (10 cm) curbed or flanged
opening and be equipped with sanitary covers.
All raw product dump pits (truck and rail) shall be surrounded by concrete aprons pitched away from the pit. Drains and a pit
drain shall be provided.
Hinged or removable covers of sanitary design shall be provided for all raw product dump pits. Design shall always allow
covers to remain in place while the truck or rail car is being positioned. It shall accommodate cleanup of dust, debris or snow
prior to removal of cover to accept deliveries.

7.15.3. Dry Bulk Ingredients

Pneumatic conveying should be used for receiving and conveying dry bulk ingredients.
Product pipelines for pneumatic conveying systems shall be designed to facilitate
cleaning.
The air supply for pneumatic systems must be adequately filtered. When moisture in the air is a concern, sufficient air-drying
equipment shall be provided.
Bulk tanks, silos, bins, etc. must be:
 PRINCIPLE #1 - CLEANABLE TO A MICROBIOLOGICAL LEVEL
 PRINCIPLE #2 - MADE OF COMPATIBLE MATERIALS
 PRINCIPLE #3 - ACCESSIBLE FOR INSPECTION, MAINTENANCE, & CLEANING/SANITATION
 PRINCIPLE #4 - NO LIQUID OR PRODUCT COLLECTION
 PRINCIPLE #5 - HOLLOW AREAS HERMETICALLY SEALED
 PRINCIPLE #6 - NO NICHES
 PRINCIPLE #7 - SANITARY OPERATIONAL PERFORMANCE
 PRINCIPLE #8 - HYGIENIC DESIGN OF MAINTENANCE ENCLOSURES
 PRINCIPLE #9 - HYGIENIC COMPATIBILITY WITH OTHER SYSTEMS
Requirements for Building Fabric

 PRINCIPLE #10 - VALIDATED SSOP & PROCESS CONTROLS VALIDATION

Storage bins shall be of metal or concrete construction. If center fill methods are used, then the tops of the bins must be sloped
to accommodate the natural angle of repose of the product being filled. This will eliminate the void areas at the top of the bins,
which can become a harborage for insects, mold, and other pests.
All interior surfaces of concrete bins shall have a smooth trowel finish to eliminate pits
and cracks. The concrete may be sealed if necessary, but painting is prohibited. Any
sealant used must be FDA or USDA approved for a food contact surface.
Bin and support structure shall be free from ledges and pockets.
All welds shall be continuous wherever possible and practical. If skip welding is used the skipped space must be rewelded after
the initial weld has cooled and set. If this cannot be accomplished, then the skipped space must be sealed with either silver
solder or liquid steel. Caulking should NOT be used.
All outside tanks shall be skirted and sealed to a concrete pad to control pests. Skirted areas shall be made accessible for
sanitation and equipment maintenance. Drains in concrete pads shall be provided. Doors shall have louvers for ventilation.
Louvers shall be covered with an 18-mesh screen and be provided with a weather hood
to prevent water entry from windblown rain.
The top deck of the silo shall have a minimum 10° pitch. The metal thickness chosen shall be sufficient to eliminate the need
for reinforcing members. The exterior of the bins, including bin vents shall be painted or coated to resist mold growth and assist
cleaning in the event of spillage.
All pneumatically loaded storage tanks shall be equipped with an adequate bin filter, including fan, to prevent over pressurizing
vessel and releasing fugitive dust through pressure relief valves.

When storage tank is outside, dust collector shall be installed inside an adjacent
building in a room designed for heat sterilization along with in-line sifters or other
inspection devices. Ductwork from top of tank to collector shall be designed to be taken apart just outside the building,
sealed, and fumigated along with the tank. IN-plant conveying control systems shall be designed to remove dust from the
collector first on the next cycle before removing additional product from the bin. The collector and fan shall be sized to handle
dust loads from both truck unloading and in-plant conveying simultaneously.
Returning in-plant conveying dust to an outside silo can result in condensation and mold growth on the underside of the top of
the silo and is discouraged.

7.15.4. Liquid Bulk Ingredients

 Receiving areas for all liquid ingredients shall be isolated from receiving toxic bulk liquids such as fuel oil,
gasoline, cleaning agents and solvents.
 All liquid ingredient receiving areas shall have a concrete slab provided to accept the vehicle and be pitched
for drainage.
 Diked unloading areas shall be provided for oil receiving to contain spills and assist cleanup. No drains are
allowed.
 All bulk liquid ingredients shall be stored inside buildings or in temperature-controlled enclosures outside.
Adequate temperature recording and control means shall be provided. Where allowed, drains and sewers
shall be installed to aid cleanup.
 Outside facilities shall be sealed to a concrete pad to prevent nesting of rodents, insects, and other pests.
 All storage tanks and piping shall be designed to be readily cleaned. Where frequent cleaning is required,
systems shall be designed for clean-in-place. All pipelines shall be designed to be self-draining to facilitate
cleanout.
 Provisions shall be made for sampling liquids adequately and for conducting bacterial tests.

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 Storage tanks and piping for milk and other ingredients capable of supporting microbiological growth shall be
constructed of stainless steel and conform to 3-A Sanitary Standards. Where appropriate, clean-in-place
systems shall be provided. Design shall provide adequate space for storage tanks and piping systems for
cleaning solutions.
 Liquid sugar and syrup tanks:
o Should be made of stainless steel. Steel or fiberglass are acceptable alternatives. If steel, interior
and exterior surfaces shall be coated with a food grade coating.
o Fiberglass tanks shall be fabricated using food grade resin materials and be steam cured.
o Piping and fittings shall be stainless steel or aluminum where acceptable.
o To prevent mold growth inside the tank headspace, a forced ventilation system using ultraviolet light
shall be installed. Filters capable of screening particles 50 microns and larger shall be provided on
the inlet to the fan and on the tank vent pipe. The fan and light system shall be adequately sized to
make up the airflow into the tank during normal “draw off” of liquid to ensure ultraviolet treatment.
 Edible oil tanks can be constructed of steel. They shall be coated with a food-grade epoxy coating both
inside and outside and have a strainer on the outlet. Use of metals containing copper is prohibited since
copper causes oils to oxidize. Stainless steel is preferred for piping and fittings and is required in wet process
areas.

7.16. Personnel Hygiene systems – (Principle 1)

Within the factory building, there must be suitable and adequate staff facilities and
amenities for changing, washing eating and resting.
 Staff facilities (e.g. restaurant, canteen, recreational area, smoking area) must not lead into food processing
areas directly. Where catering facilities are provided, they must be designed and suitably controlled to
prevent contamination of the food product.
Requirements for Building Fabric

 Where provided, designated smoking areas shall be isolated from production areas to an extent that smoke
cannot reach the product.
 Changing room arrangements must provide an adequate number of flush lavatories connected to an effective
drainage system. Lavatories
are not to open directly into rooms in which food or
packaging is handled, nor into rest rooms or changing rooms. After using the
toilets, there must always be two hand washes prior to re-entering production areas; one within the toilet
washroom and one at the entrance to the production area. No toilet facilities, other than hand
wash basins, shall be in High Care Zone. Sanitary conveniences must have adequate
natural or mechanical ventilation and ideally be under negative pressure.
 Toilets, urinals and related cubicle dividers must be mounted from the walls to facilitate cleaning. Toilets
must utilize hands free flushing mechanisms (see Figure 72).

Figure 72 - Toilet and cubicle dividers mounted from wall for ease of cleaning.

Adequate changing facilities for personnel must be provided of a size to allow the storage of personnel effects and street
clothing. Lockers for storing outdoor clothing must be separate from those for storing work clothes. In addition to toilet and
handwashing facilities, personnel must have access to showers where appropriate. Changing facilities must be sited to allow
personnel direct access to the production, packing or storage areas without the need to walk through any external areas
wherever possible.
An adequate number of permanently installed wash basins must be available in toilet and washroom areas, at the entrance to
processing areas, and must be designated for washing hands only. Wash basins must be:
 Suitably located, e.g. at each entry point to the processing area and within the washroom.
 Of a size that allows easy and effective hand washing but discourages washing of other items and
constructed out of stainless steel or similar non-corrodible material.
 Fitted flush to the wall (with no crevices) or set at least 5cm away from the wall to facilitate cleaning.
 Fitted with trapped waste pipes leading directly to drain.
 Provided with hot and cold running water, with mix valves as appropriate, materials for cleaning hands and for
hygienic drying.
 Knee, foot, elbow or automatically (hand contact-free) operated.

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Figure 73 - Example handwashing station

7.16.1. Sinks
Material and Manufacture
 All sinks to be manufactured from Stainless steel, 304SS as an absolute minimum.
 All parts or accessories associated with the sinks should be made from corrosion resistant metals.
 The basin of the sink should be ideally formed and not fabricated. This is to avoid as many welded joints as
Requirements for Building Fabric

possible, which will in turn help maintain a clean and smooth surface finish.
 The sink outer skin should be seamlessly produced so that there are no crevasses or areas for dirt or water
harborage.
 The underneath of the sink should not have any ledges or areas which are inaccessible for cleaning, See
figure 1.
 All penetrations in the sink, should be of a standard size so that it is more likely the accessories fit correctly.
 All horizontal surfaces should be sloped towards the basin or the drain point, See figure 2.
 The material thickness of the basin or the upstand should be enough so that they do not warp or bend when
fixed in position (Min 2mm for basin)
 Sink upstands or back splashes ideally should be formed as one piece with the sink basin and should be
sized appropriately to fit hand wash and hand sanitizer fixtures, See figures 3&4.
 The upstand should follow the contour of the wall and be fully sealed. There should not be any area behind or
underneath the upstand which is inaccessible, See figure 4.
Format and Use
 The basin size should be fit for purpose, e.g. what size is the equipment to be washed for a COP sink? or
how many people need to wash their hands at once for a personnel sink? See approximate dimensions in
figures 1&2.
 COP sinks should be divided up in the sections, determined by the activities and procedure in washing
equipment for that site, e.g. Soak, Scrub, Rinse, Sanitize. See figures 2&5
 Larger sinks which are suitable for multiple handwashing at once, ideally should have only one drain. This
ensures that the fabrication of slopes to drain are easier to achieve during manufacture, multiple drain points
leads to dead spots with standing water.
Accessories
 The sinks should be fitted permanently to walls only (Ideally concrete walls, not hygiene panel), permanent
fastening to floors is not permitted.
 The feet of the sinks should be made from plastic or rubber so that they are easy to clean, they should be
also be adjustable so that they can cleaned under fully. Figure 6.
 As shown in the figure 4, all supports are cylindrical to ensure less chance of dust settling on them.
 Sinks should be operated handsfree, this can be done with an aperture operated by the knee or through
sensor activated taps. See figure 3.
 P Traps should be easy to dismantle for cleaning purposes. See figure 3.
 COP Sinks should have the “Drench type” hose fittings to ensure flexibility when cleaning difficult pieces of
equipment. See figure 5.
Services
 Sites should try to ensure an immediate flow of hot water; this can be achieved with either a local heater or
the central hot water supply having the flow and return pipes located near to the sinks.
 Water mixers can be used, ensure that they do not restrict the flow of water, they balance the water
pressures and the adjustment knob is lockable or at least calibrated.
 The water supplied to the sink should be a minimum of 45°C.

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Figure 74 - Two person handwash sink (left) and three basin COP sink (right)
Requirements for Building Fabric

Figure 75 - Single person handwash basin (left) and three compartment COP sink (right)

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8. Utilities/Services
8.1. General Requirements - (Principle 7, 8, 10)
Wherever possible pipes, conduits, wiring, etc. must run in a separate accessible
gangway (pipe train/pipe chase) and enter the process area through the ceiling. If this is
not possible open racks or trays that are fixed to walls or columns close to the ceiling must be used. These trays must
be designed hygienically to minimize the presence of horizontal ledges, crevices or
gaps where inaccessible dirt can accumulate. Inverted angle, sealed round tubing, or flat plate trapeze
hangers supported by smooth, minimally threaded rods must be used. Fasteners on hangers must be locking/lockable to
minimize risk of foreign object contamination.
The use of Unistrut (B-Channel) is prohibited in processing areas.

Figure 76 - Unistrut (B-Channel)

Pipework suitably protected light fixtures, ventilation points and other services in manufacture areas must be installed to
minimize dirt accumulation, and to avoid creating recesses which are difficult to clean e.g. flush mounted or suspended an
appropriate distance from the walls or ceiling.
Anchor points of support racks must be sealed to the building (e.g. wall, floor, columns, ceilings).
Utilities/Services

Penetrations through walls, ceilings, and floors must be sleeved to prevent damage to the substrate. Supports must be
positioned to account for process piping thermal expansion/contraction (see Figure 77). Sleeves through floors must extend
above the upper surface to prevent spillage of soil or cleaning solutions into lower floors (see
Figure 78). Completely sealing smaller voids is also acceptable (see Figure 79).
When several pipes penetrate the floor, these can be circumvented by a larger curbed area to improve the cleanability of the
surround process area.

Figure 77 - Piping penetration through wall - incorrect (left) and correct (right).

Figure 78 - Example of penetration through a floor showing correct height of sleeve (right).

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Figure 79 - Sealed utility penetration

All piping, both utility and process, shall be identified by coding or labels to prevent
inadvertent cross-contamination.
The manufacturing environment must be controlled, or insulation materials must be used to ensure that drips and condensation
do not form on pipework or other utilities that could contaminate foods, raw materials, or food contact surfaces.
Conveyors, services, vents, etc. must be sealed int any walls, ceilings, and partitions through which the pest to prevent pest
ingress.
Control valves and piping for refrigeration systems are located outside of the processing area whenever possible.

8.2. Piping – (Infrastructure Principal 7)

All piping, both utility and process, shall be identified by coding to prevent inadvertent cross-contamination.
Dead ends and dead legs shall be kept less than the current standard of 1-½ times the diameter of the pipe for process and
Utilities/Services

potable water piping. Dead legs sometimes occur with thermometer probes of flow meter probes in process, steam and water
lines but must be kept less than 1-½ times the diameter of the pipe.
Piping materials shall be selected to avoid contamination of process liquids by erosion or chemical interaction with the pipe.
Piping must be designed and installed to avoid dead ends. Pipes must be installed to provide sufficient spacing for cleaning.
Whenever possible, utility lines should be located above the ceiling of processing areas.
Back flow preventers shall be incorporated into all potable water lines. Mechanical back flow preventers shall be used when air
gap prevention is not practical.
To avoid residue collection points, piping networks must have clearances for:
 100 mm / 4 inches between each pipe
 50 mm / 2 inch from the walls and floors (minimum)
 250 mm / 10 inches between parallel rows of piping
 All pipework must be drainable. In general, a 3° slope towards a drainage point achieves this. Pipe size
reductions, fitting of pumps, etc. must be designed to ensure this. See 3-A accepted practice 605-04
“Permanently Installed Product and Solution Pipelines”
 Exterior surfaces of pipes that traverse wall must have water and airtight contact with the wall when the wall
separates different hygienic zones (see Figure 80). If both sides of the wall are the same hygiene zone, the
water and air tightness is not essential, but any openings must be large enough for cleaning around the entire
areas (at least 50mm / 2”). Any seals used must be flexible, and able to expand/contract in a similar way to
the pipe.

Figure 80 - Sealed pipe transfers through a ceiling.

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Figure 81 - Examples of sealed conduit transfers through walls.

Unless securely covered, the use of open cell insulation should be avoided. This includes Fiberglas batting, Armaflex®, rigid
foam, and Styrofoam. Closed cell insulation is recommended. Utility line wrapping should be made as durable as possible to
withstand daily applications of high-pressure, high temperature water, commercial grade chemicals, and physical damage.
Stainless steel is wrapping is recommended for insulation when within 2.5 m / 8 ft of the walking surface or where it may
otherwise become damaged by impact.

Table 10 - Insulation types for process and mechanical piping.

Utilities/Services

Where insulation is only needed for human safety reasons, i.e. preventing burns from hot piping, stainless steel cages may be
adequate and easier to clean (see Figure 82).

Figure 82 - Steam piping with protective guarding

8.3. Electrical Service – (Infrastructure Principal 7)

8.3.1. General Requirements
Construction materials for electric and electronic instruments and cabling should be:
 Hygienic (smooth, non-absorbent, non-toxic, easily cleanable, impervious and non-mold supporting):
 Chemical resistant (non-degrading and maintaining its original surface finish after sustained contact with
product, process chemicals, cleaning agents).
 Physically durable and mechanically stable (resistant to steam, moisture, cold, the actions of cleaning and
sanitizing agents, abrasion and corrosion resistant, resistant to chipping, unbreakable) and as easy to
maintain.
 Materials should be used having a roughness area R a that is as low as practicable to minimize cleaning
time. It is recommended that the surface roughness, R a, for conduits, enclosures and such like for
installation in hygienic production areas should not exceed 2.5 μm.

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Lead, cadmium and mercury are largely present in electric and electronic devices: batteries, fluorescent lamps, light bulbs,
Black Light Blue (BLB) lamps (used in UV-based insect killers), IT and telecommunications equipment (optical and filter glass,
switches), monitoring and control instruments, semi-conductors, plasma and electron emitter displays, electronic ceramic parts
(e.g. piezo-electronic devices), connector systems, electrical/mechanical solder joints to electrical conductors, etc.
Therefore, it is very difficult to exclude their presence in the production, packaging, and
storage areas within the food factory. However, electrical, and electronic devices should
never be installed in or exposed to the food contact area. They must always be enclosed in junction
boxes, casings, closed cable housings, cabinets, etc., and be installed in the non-product contact zone or in technical corridors
and rooms.

8.3.2. Cable Runways

Electricity supply must be suitable to the need of the specific zone within the facility (processing and packaging equipment,
freezers and cold stores). In production areas, the electrical and control installations should be limited to those that are
necessary for the safe and correct operation of the plant.
 Exposed wire ways must be avoided, due to their difficulty for effective cleaning. Cabling
should be
routed outside the production e.g. technical ceilings and service corridors.
When both the electrical and control installations is still located within a production area, e.g. cabling to power
motors or plant machinery, control cables connecting sensors via field boxes/cabinets to the plant control
system, etc. These
cables should be routed, and connections made to create
hygienically acceptable installations conforming hygienic zone.
 The use of cable trays must be avoided in high care or critical care environments. The use of fully sealed
conduit, with appropriately sealed junction boxes must be used.
 Where cables exit from junction boxes single dedicated cable glands must be used to prevent ingress of soil,
insects, water or other debris (see Figure 83 - Junction box showing sealed cable [Link] 83.)
Utilities/Services

Figure 83 - Junction box showing sealed cable glands.

 The use of cable trunking is acceptable. When used in production environments trunking should be
completely sealed with a gasket (see Figure 84). Junctions to the trunk should be made using sealed conduit
or appropriate sealed cable glands.
 The installation of power lines and electrical cables should eliminate harborage points

Figure 84 - Cross sections of cable trunk with sealing gasket.

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 Cables should be made of plastic material that can withstand corrosive cleaning agents and cleaning
chemicals / sanitizers.
 Only electrical cables with a round cross-section should be used, they should be of a smooth type without
longitudinal crevices.
 Corrugated cable housings must NOT be used in the food processing area
to prevent dirt accumulation.
 Connections to plant that are subject to vibration (e.g. motors) should be made via a flexible, liquid tight,
electric current carrier having a smooth outer surface.
 Straight line cables should be used, and spiral-wound power lines should be avoided. The latter can
accumulate dust, dirt, product soil, etc., very easily and are very difficult to clean.
 Tangled cable arrangements must be avoided, they may become breeding grounds for vermin and pests and
consequently microorganisms (see Figure 85). Cables,
hoses, etc., should be routed in a
way that makes it possible to see dirt – e.g. the routings should be as open
and visible as possible to facilitate cleaning around and between them.
Utilities/Services

Figure 85 - Bundled/Tangled cable arrangements readily accumulate soil and should not be used.

 It is recommended that cables be spaced at least 25mm (1inch) apart in cable trays to facilitate cleaning (see
Figure 86).

Figure 86 – Ideally cables should be spaced appropriately when used in cable trays via fixed spacer blocks or support lanes in
the tray.

 The length of cabling runs in processing areas should be as short as possible. Vertical installation of cables
should be preferred to horizontal, to avoid accumulation of any soil.
 Cables should come from the ceiling; hanging on the ceiling. Attempts should be made to minimize individual
ceiling drops.
 Cable ladders, wire trays and electrical conduits should set off the wall for
better cleaning or shall have adequate spacing to allow for cleaning.
 The amount of wire ways and conduits, as well as cable routing, must be kept to a minimum in production
areas with exposed product.

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Figure 87 - Ideally installed trapeze style pipe/conduit hanger.

Wall or piping rack installations are preferred over cable routing along conveyors, tanks and other production equipment.
Cable ladders and trays must be as open as possible. If cable routing cannot be avoided where product is exposed, to avoid
Utilities/Services

soil accumulation, horizontal surfaces must be kept to a minimum and the design shall be sloped at 45 degrees.
Rods/hangers must have minimal threads at the end. The amount of hangers must be minimized, and must not be used above
exposed product zones.
Vertical or angled cable trays wherever possible.

Figure 88 – Correct (right) and incorrect (left) mounting of electrical cable trays.

Figure 89 - Properly installed cable trays, note the use of single cables and not cable bundles.

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Cable routing under production lines/equipment must be avoided, esp. in areas where
they might become covered with product residue.
Cables in exposed trays must not be bundled. Cables must have sufficient distance to each other to allow for cleaning.
If conduit is used conduit must be completely sealed, with cable exiting at a junction or control box with a proper sealing gland.

Figure 90 - Improperly sealed conduit presents a food safety risk

Cable trays must NOT be installed in a way that allows personnel to use them as a step.
When cables pass from one hygiene zone to another the opening must be sealed (e.g. utilization of a junction box sealed to the
wall) to prevent cross contamination between the zones. The junction must allow for inspection and cleaning.
Final drops from routing to equipment must be as short as possible, excess cable must not be looped near the equipment.

8.3.3. Enclosures and Control Panels

Electrical cabinets shall be designed and installed in a way that they are cleanable and compatible with the production
environment.
Utilities/Services

Table 11 - NEMA / IP rating requirements for electrical panels

Wet Controlled Wet Dry

IP68 / NEMA 4 IP 55 / NEMA 12 IP 55 / NEMA 12
NEMA 4X must be specified if Aluminum may be used
routinely cleaning with chlorine
containing chemistry or in highly
corrosive environments.

Electrical Enclosures shall be equipped with strap style hinges. Where possible hinges must be located inside the enclosure.
Piano hinges are prohibited in process areas.
Cable and conduit entry shall be from the bottom through sealed couplings or glands of the same IP/NEMA rating as the
cabinet.
Cabinets shall have no optional entries for future use to avoid the use of caps.
Cabinets must have sloped tops (at least 30°) to prevent soil and liquid accumulation and to prevent their use as shelves.
Conduit should exit from the sides or bottom of panels to minimize risk of dust or moisture intrusion (See Figure 91).
All electrical equipment shall be mounted away from walls and fixed equipment to facilitate cleaning (See Figure 92) If adequate
spacing is not possible the enclosure must be permanently sealed to the wall.
Control panels must be elevated from the floor using a solid concrete plinth, steel framework or affixed to the wall.
Electrical cabinets, HMIs, and PLC panels must not be located directly over exposed product zones.

Figure 91 - Electrical Conduit exiting panel from the side.

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Figure 92 - Well installed electrical control box (left) and incorrectly installed over product area (right).

Control panels with touchscreens are preferred over devices with buttons or keyboards with computer mice. Where buttons are
necessary, they must be hermetically sealed prevent the ingress, or accumulation of moisture and dirt.

8.4. HVAC – (Infrastructure Principal 3 and 7)

8.4.1. General Requirements
Building HVAC system must be:
PRINCIPLE #1 - CLEANABLE TO A MICROBIOLOGICAL LEVEL
PRINCIPLE #2 - MADE OF COMPATIBLE MATERIALS
PRINCIPLE #3 - ACCESSIBLE FOR INSPECTION, MAINTENANCE, & CLEANING/SANITATION
PRINCIPLE #4 - NO LIQUID OR PRODUCT COLLECTION
PRINCIPLE #5 - HOLLOW AREAS HERMETICALLY SEALED
Utilities/Services

PRINCIPLE #6 - NO NICHES
PRINCIPLE #7 - SANITARY OPERATIONAL PERFORMANCE
PRINCIPLE #8 - HYGIENIC DESIGN OF MAINTENANCE ENCLOSURES
PRINCIPLE #9 - HYGIENIC COMPATIBILITY WITH OTHER SYSTEMS
PRINCIPLE #10 - VALIDATED SSOP & PROCESS CONTROLS VALIDATION

They must also:

 Provide adequate fresh air for personnel
 Control ambient temperature and humidity to ensure the safety and quality of foods
 Effectively remove fumes, smoke, steam, vapors and condensate
 Effectively remove excess heat
 Effectively distribute air throughout rooms so that no dead zones are created
 Control odors which might affect the suitability of food
 Reduce the number of airborne contaminants, including microorganism

Airflow within the building must flow from higher to lower hygienic zones and from lower to higher dust loaded areas (note:
control of allergenic ingredients and related cross contact may require slightly different design considerations). Where
necessary airlocks must be used to control airflow between hygienic zones.

Figure 93 - Example of proper air flow within a facility.

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Figure 94 - Common Particle Sizes of Airborne Contaminants.

Buildings must be operated under a slight positive pressure (2-7Pa) with differential
pressure maintained between different hygiene zones.
Where there is a risk of microbiological contamination of the product by the surrounding air, the working area must be
enclosed as far as possible and be maintained at a positive pressure using filtered air drawn from a clean source
(preferably from within the building envelope).
Air filtering for supplied area is recommended for Medium hygiene areas with EU class M5 to F7 filters. For high hygiene areas
filtering must be F7 or greater dependent on the external factory risk and microbial sensitivity of the product. In some cases,
High-efficiency particulate absorption (HEPA) filters (H13-H14) may be appropriate.
Ventilation systems in Wet Cleaning must have a dedicated washdown mode to ensure ready removal of steam and
rapidly dry the room after cleaning.
Utilities/Services

8.4.2. Mechanical Ventilation Systems

System must be:
PRINCIPLE #1 - CLEANABLE TO A MICROBIOLOGICAL LEVEL
PRINCIPLE #2 - MADE OF COMPATIBLE MATERIALS
PRINCIPLE #3 - ACCESSIBLE FOR INSPECTION, MAINTENANCE, & CLEANING/SANITATION
PRINCIPLE #4 - NO LIQUID OR PRODUCT COLLECTION
PRINCIPLE #5 - HOLLOW AREAS HERMETICALLY SEALED
PRINCIPLE #6 - NO NICHES
PRINCIPLE #7 - SANITARY OPERATIONAL PERFORMANCE
PRINCIPLE #8 - HYGIENIC DESIGN OF MAINTENANCE ENCLOSURES
PRINCIPLE #9 - HYGIENIC COMPATIBILITY WITH OTHER SYSTEMS
PRINCIPLE #10 - VALIDATED SSOP & PROCESS CONTROLS VALIDATION

Mechanical ventilation systems must:

 Consist of Air Handling Units (AHUs) of food grade quality
 Be comprised of AHUs designed to allow for easy access for inspection, maintenance and cleaning.
 AHUs must be placed as far as is possible from the processing area.
 Have adequate controls for temperature, humidity and filtration as necessitated by the production process
and the external environment.
 Have appropriately sited air intakes and extracts to prevent short circuits between inlet and outlet.
 Have minimal ducting. Ducting must be accessible for cleaning and inspection and be designed to minimize
accumulation of soil (i.e. round vs square ducting) If ducting requires insulation the insulation must be
mounted on the outside of the duct.
 Filter air prior to coming in contact with internal cooling coils.
 Ensure that filters can be properly fitted to ensure that filters are not bypassed.
 Located to allow filters to be removed into lowest hygiene zones and away from production areas.
 Have external air intakes which are appropriately screened against pest access at least 1m above internal
and external ground levels (accounting for possible snow accumulation) and away from any other possible
source of contamination.
 Have intakes and exhaust positioned with due regard for the local environment (rain, prevailing wind) and the
avoidance of nuisance (odor, noise, or dust emissions)

8.4.3. Duct Work

 Round duct is preferred. Provide a minimum 6-inch (15 cm) clearance all around duct work for cleaning.
 Where rectangular duct must be used, provide a minimum 18-inch (46 cm) clearance all around the duct.
 Access doors, a minimum of 16x24 inches (41x 61 cm), shall be provided on all 18-inch (46 cm) diameter and
larger ducts. A 24 to 30 inch (61 to 76 cm) removable section of duct shall be provided for duct sizes less
than 18 inches (46 cm) in diameter. They shall be on 12-foot (3.9 m) centers and on each side of turning
vanes and damper installations, and in each straight run separated by an elbow or tee.
 All ductwork seams shall be sealed with caulking to eliminate insect harborage.
 Flush mounting ducts to the ceiling or walls is prohibited since it is practically impossible to keep these joints
sealed with caulk due to movement from expansion and contraction.

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 All wall openings for ducts shall be sealed with a sleeve fitted flush with the wall on both sides. A minimum 2-
inch (5 cm) clearance shall be provided between the duct and sleeve all around the duct for cleaning.
 Floor openings for ducts shall be sealed with a sleeve which extends a minimum of 4 inches (10 cm) above
the floor. A minimum 2-inch (5 cm) clearance shall be provided between duct and sleeve all around the duct.
 If ducting insulation is required, it must be on the exterior of the duct.

8.5. Process air – (Infrastructure Principal 3 and 7)

Process and transport air must be supplied from areas least likely to contain
concentrations of airborne dust and micro-organisms. Externally sourced process air must be drawn
from an inlet at least 3 meters above ground level. Air intakes must be sited at far as possible (≥ 10 M / 30 ft) from outlet air
streams or other likely contamination sources (e.g. droplets from cooling water equipment, wet scrubbers, exhaust ducts).

Process and transport air must be effectively filtered for dust and other particles. Air
coming in contact with the product is more important than room air. Coarse filtration may be
appropriate for raw materials, but the air for dry ingredients and products may require fine filtration (i.e. EU-class F7). The
need for filter level must be determined by risk assessment, e.g. raw flour will require less filtration than milk powder or infant
formula.
Air used to transport product should be filtered to at least two grades of air filter above the air filters used for the room. For
example, if F7 filters are used for the processing room then processing air must be filtered to at least F9.
Systems using process and transport air operating below atmospheric pressure must not cross process areas of lower
hygienic zone classification. The air must be conditioned to prevent condensation.

8.6. Compressed air – (Infrastructure Principal 7)

Compressed air or other gases mechanically introduced into food or used to clean food contact surfaces or equipment (not
recommended for new sites) shall be dry and treated to be free of microorganisms, chemicals and particulates.
Access points to all internal gas systems [Ammonia, Carbon Dioxide, Nitrogen, etc.], including access points at external
storage tanks, must be secured under locked protection or restricted access when not in use
The standard used for food contact compressed air (e.g. air purge systems, mechanical seals, etc.) shall meet ISO8573-
1:2010 – 1.2.1 (Class 1 = Particulates (concentration); Class 2 = Water (dewpoint); Class 1 = Oil (concentration)) as per table
below.
Utilities/Services

Air shall be supplied from a clean space or from clean outside air and should be passed through an upstream filter.
Air under pressure shall be oil free by use of oil free compressors.
Compressed air should be dried to suitable dew point to prevent the condensation of water in the compressed air line.
Air under pressures greater than 15psig (1bar) shall be provided with a means to remove water to prevent free water in the
system.
All piping downstream of the final filter is considered to be a product contact surface and shall meet all materials and
construction requirements for product contact surfaces.
Air piping from the compressing equipment to the moisture trap and final filters must be readily drainable
Point of use filters shall be used and these should be located as close as possible to the point of use:
 0.3-micron filters at 99% efficiency, when sterile air is required then 99.9% efficiency is required
 The final filter media shall be disposable, final filters shall be located in the air line upstream from and as
close as possible to the point of application
 Filter media should not be cleaned and reused
If compressed air has to be used for cleaning food processing equipment than it should be food grade quality in order to avoid
contamination with oil residues, particles or micro. Compressed air should not be used to substitute vacuum cleaning and
should only be used as last cleaning resource due to the associated food safety (dust and soil dispersion) and health and
safety (noise and particles). Compressed air cannot be used to clean floors.
Table 12 - Recomended air quality for compressed air

Need picture of compressed air filter near point of use.

For additional reference see 3-A Accepted practice 604-05 “Supplying Air Under Pressure in Contact with Milk, Milk Products
and Product Contact Surfaces” and ISO8573-1:2010 – 1.2.1

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8.7. Dust collection – (Infrastructure Principal 3)

System must be:
PRINCIPLE #1 - CLEANABLE TO A MICROBIOLOGICAL LEVEL
PRINCIPLE #2 - MADE OF COMPATIBLE MATERIALS
PRINCIPLE #3 - ACCESSIBLE FOR INSPECTION, MAINTENANCE, & CLEANING/SANITATION
PRINCIPLE #4 - NO LIQUID OR PRODUCT COLLECTION
PRINCIPLE #5 - HOLLOW AREAS HERMETICALLY SEALED
PRINCIPLE #6 - NO NICHES
PRINCIPLE #7 - SANITARY OPERATIONAL PERFORMANCE
PRINCIPLE #8 - HYGIENIC DESIGN OF MAINTENANCE ENCLOSURES
PRINCIPLE #9 - HYGIENIC COMPATIBILITY WITH OTHER SYSTEMS
PRINCIPLE #10 - VALIDATED SSOP & PROCESS CONTROLS VALIDATION
Any production processes that create dust must have appropriate measures installed to
minimize the spread of dust into the production environment.
This is of particular concerns in processes that handle ingredients that may create a cross contamination risk, i.e.
allergenic materials. Dust can be mitigated through proper sealing of equipment, management of pressure gradient
and through the installation of dust collection equipment. Processes that must have appropriate fugitive dust
management include:
 Bag dump stations
 Dry blending
 Dough making
 Dry material transfer
 Bagging/packaging of dry materials
 Cereal coating/drying
Systems must be designed to:
 Adequately collect the dust being generated.
 Collect dust as close to the point of generation as possible.
 Not increase the risk to product through operation.
 Be durable and resistant to corrosion under conditions of use.
Controls must be included to monitor condition of bags/filters and provide an alarm state indicating failure of bag.
(Magnehelic, photohelic, particulate sensors).
Utilities/Services

8.8. Lighting – (Infrastructure Principal 7)

All areas where food is examined, processed, or stored, and where equipment or utensils are cleaned, and in
personnel changing areas, must have adequate natural and or artificial lighting for the activities conducted. Where
necessary, lighting must provide sufficient color rendering, such that the lighting gives product and surface colors the same
appearance as they have under daylight. Lighting of poor color rendering gives marked distortion of the original product color.

Table 13 - Recommended illumination levels for factory areas

Lux
Location (lumen / m2) Foot Candles
Exterior, plant perimeter 110 10
Receiving docks 110 10
Shipping Docks 110 - 220 10 - 20
Warehouses 220 25
Processing areas 440 - 660 45 - 60
inspection points 550 - 1500 50 - 140
packaging areas 440 - 825 45 - 80
Offices 440 - 550 45 - 50
Corridors 220 20

Lighting must be suitable sealed to the ceiling or walls in a way that avoids any
projections where dust can accumulate or spaced off them to give easy access for
inspection and cleaning. Lights must have sloped tops to enable cleaning.
Lighting fixtures and their supports are designed to avoid accumulation of dust (especially where cross contamination risks
could arise) with horizontal surfaces minimized.

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Figure 95 - Hygienic (right) and un-hygienic (left) lighting design

 Where possible, light sources must be integrated into ceilings and walls in a way that
avoids any projections where dust can accumulate. Where direct lighting in specific positions
within the equipment is necessary, lighting fixtures must also be integrated into the equipment design
according to hygienic design requirements.
 Light sources must not be placed above open processes, to prevent broken fragments falling into open
process equipment if damaged. When such a light source cannot be avoided e.g. above a monitoring point,
non-glass tubes or shatter proof glass must be used.
 Light sources (bulbs or tubes) must be covered with a protective film or by polycarbonate plastic to prevent
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glass shattering or breakage. These lights must be changed regularly as protective films become brittle over
time.
 Light sources must have watertight, dust tight and insect tight enclosures and be durable under cleaning
conditions in the areas of use (see 8.3.3 Enclosures and Control Panels)
 For ease of cleaning or maintenance in areas where product is exposed, it is preferable that fittings can be
removed from their support (e.g. attached to the wall or ceiling only by a cable and a plug-in socket). An
alternative is to have light fittings accessible from a walk-on ceiling (see Figure 96).

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Figure 96 - Lighting installation detail showing easy disconnection of light using plugs (left) and installation detail for
fixture integrated with IMP ceiling for access from above (right).

8.9. Water – (Infrastructure Principal 7, 10)

Factories must have an adequate supply of potable (hot and cold) water, which is to be used whenever necessary to ensure
that foodstuffs are not contaminated. Potable water must meet WHO, US-EPA, or local/regional requirements, whichever is
stricter.
Where appropriate, facilities for water storage, distribution and temperature control shall be adequately designed, constructed
of approved materials and of a size that prevents stagnation, shall be covered and shall have air vents which are insect and
rodent proof.
Plumbing shall be of adequate size and design and adequately installed:
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 To carry sufficient quantities of water to required locations throughout the plant

 To ensure potable water is not contaminated with non-potable water
 To prevent a source of contamination to food, water, equipment, utensils or create unsanitary condition.
 So that all hoses, taps, and other similar sources of possible contamination prevent backflow or back
siphonage. Air breaks or mechanical prevention methods are acceptable. Mechanical back flow preventers
must be properly maintained and inspected.
 To properly convey sewage or liquid disposal wastes.

In dry processing factories, the infrastructure and equipment must be specifically

designed to accommodate water. Water (and associated drainage if required) must only
be piped to areas requiring such water. If possible, these areas, or the operations requiring water must be
grouped together and placed at one edge of a factory to minimize water and drainage runs.
For areas where water may constitute a microbiological risk, no water or drainage pipes of any description must run through
these areas. Close attention must be paid however to fire regulations and if sprinkler systems are required dry systems must
be considered.
Recirculated
Recirculated water must be treated, monitored and maintained as appropriate to the intended purpose.
water must have a separate distribution system which is clearly identified (e.g. by color,
marking or printed notices).
It is recommended that hot water recirculation loops be used to maintain hot water temperatures at point of use. Where water
recirculation loops are used temperatures should be maintained ≥ 60°C / 140 °F.
Where non-potable water is used, (e.g. fire control, steam production, refrigeration, etc.) it is to circulate in a separate, duly
identified system. Non-potable water must not connect with or allow reflux into potable systems.
Steam that is used for direct product contact must be:
 Generated from potable water, locally, in an isolated system and must be adequate to meet operations
requirements.
 Equipped with traps must ensure adequate condensate removal and elimination of foreign material. Steam
traps must not be drained directly to the floor, they must be routed to an appropriate drain utilizing an air
break.
 Utilize boiler treatment chemicals that are approved for direct product contact.
 See 3A Accepted Practice 609-03: “Method of Producing Culinary Steam”
Local legislation must be followed with regard to protection of the potable water supply. A connection between the water
piping and make-up tank, such as for storage, cooling, or condensing, must be protected by an air gap or effective backflow
preventer.

8.10. Food and Solid Waste – (Infrastructure Principal 1)

Adequate provision must be made for the storage and disposal of food waste, non-
edible by-products and other refuse, considering local legislation requirements for
waste categorization.
Food waste, non-edible by-products and other refuse must be deposited in appropriately constructed, labelled, closable
containers which are made of impervious material, are leak-proof and are easy to clean and disinfect.

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The routing of how waste products must move to internal or external waste storage
facilities and, if internal, from storage areas to the outside of the factory, must be
considered. Waste must be moved out of High hygiene areas via openings in the
segregated barrier.
Waste flows should be completely segregated from finished products. Ideally waste flows should also be segregated from
raw materials, if this is not possible a method should be in place to prevent raw materials from being contaminated by waste
streams.
For the disposal of small quantities of bagged waste in High hygiene areas, existing hatches must be used e.g. raw material
or packaging materials entrance hatch (Figure 97), as additional hatches increase the risk of external contamination and put
extra demands on the air handling system. For larger amounts of waste or waste collected in bins, dedicated, easily cleanable
hatches must be used.
Waste storage areas must be designed and constructed so that the risk of contaminating food or the potable water supply is
avoided and to minimize the potential for odor. Storage must be in a separate room or in an external area that is constructed
of impervious material and suitably sloped and drained. Refuse stores are to be designed and managed in such a way as to
enable them to be kept clean and be fly-proofed and free from animals and pests.
Microbiological and chemical wastes from laboratories require special attention, may require special disposal methods,
including sterilization, and may need to meet local legal requirements.
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Figure 97 - Dedicated hatch for waste removal from a high hygiene area.

8.11. Cleaning Facilities, Equipment, and Chemicals– (Infrastructure Principal 7

and 10)
Adequate facilities must be provided, where necessary, for the cleaning, disinfection
and storage of working utensils and equipment. Such facilities must be adequately
separated from food storage, processing, and packaging areas to prevent
contamination and be constructed of corrosion resistant materials, be easy to clean
and have an adequate supply of hot and cold water.
Cleaning agents and disinfectants must be stored separately, in clearly identified containers, from areas where food is
handled. A separate lockable area inside a food handling, ingredient or packaging store is not acceptable.
Cleaning chemical stores must:
 Be sound, dry, well ventilated, frost proof, have ease of access and have sufficient light to enable the
operator to read the label.
 Be designed so that drainage from this area must be contained in the event of a hazardous spill.
 Be secure (lockable), with controlled access.

Location of hose stations are sufficient & hose lengths are long enough to ensure all points are accessible without draping or
carrying hoses across process equipment. Rooms for wet washing must be equipped with suitable equipment for foaming
and sanitizing equipment in a timely fashion.

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8.12. Fire Suppression and Associated Systems

Several aspects should always be considered when protecting a plant against fire. First and foremost, the lives of people
working in the plant need to be protected by making sure that nobody is likely to be injured should a fire start. This aspect is
usually covered by rules and obligations imposed by the relevant authorities (e.g. ATEX, NFPA, local regulatory codes).
Protecting the property itself and avoiding a lengthy business interruption is a second concern but is normally not an issue for
the authorities. Therefore, complying with the relevant authorities’ rules in most cases is not sufficient to protect company
assets and keep it viable in the event of a fire.

Early detection of fire is a critical prerequisite to subsequent control. Appropriate smoke and heat detections systems should be
installed in areas that are, not continually occupied, considered operation critical, and/or have a high fire load (i.e. packaging
storage). Automated suppression systems should also be included where necessary to ensure safe operations.

Any equipment installed for fire detection and/or suppression must be hygienically appropriate for the zone in which it is located

 Hygienic (smooth, non-absorbent, non-toxic, easily cleanable, impervious and non-mold supporting):
 Chemical resistant (non-degrading and maintaining its original surface finish after sustained contact with
product, process chemicals, cleaning agents).
 Physically durable and mechanically stable (resistant to steam, moisture, cold, the actions of cleaning and
sanitizing agents, abrasion and corrosion resistant, resistant to chipping, unbreakable) and easy to maintain.
 Materials should be used having a roughness area R a that is as low as practicable to minimize cleaning
time. It is recommended that the surface roughness, R a, for conduits, enclosures and such like for
installation in hygienic production areas should not exceed 2.5 μm.

System must be:

PRINCIPLE #1 - CLEANABLE TO A MICROBIOLOGICAL LEVEL
PRINCIPLE #2 - MADE OF COMPATIBLE MATERIALS
PRINCIPLE #3 - ACCESSIBLE FOR INSPECTION, MAINTENANCE, & CLEANING/SANITATION
PRINCIPLE #4 - NO LIQUID OR PRODUCT COLLECTION
PRINCIPLE #5 - HOLLOW AREAS HERMETICALLY SEALED
PRINCIPLE #6 - NO NICHES
PRINCIPLE #7 - SANITARY OPERATIONAL PERFORMANCE
PRINCIPLE #8 - HYGIENIC DESIGN OF MAINTENANCE ENCLOSURES
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PRINCIPLE #9 - HYGIENIC COMPATIBILITY WITH OTHER SYSTEMS

PRINCIPLE #10 - VALIDATED SSOP & PROCESS CONTROLS VALIDATION

Piping for fire suppression systems must be installed in a hygienic manner appropriate for their hygienic zone See section 8.2
Piping – (Infrastructure Principal 7) above.

Water used for fire suppression purposes must be of appropriate microbiological quality.

In areas where fire suppression nozzles are exposed and may accumulate dust, grease, or other buildup a program must be in
place to inspect, clean and replace these nozzles as necessary to ensure good function. Nozzles should be of the fusible
element type (see - Figure 98). Glass bulb elements must not be used.

Figure 98 - Fused metal element type fire sprinkler head. Viking Group (link).

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9. References
 EHEDG Design principles for food manufacturing
 CFR 21
 3-A SSI
 OpX: One Voice for Hygienic Equipment Design for Low-Moisture Foods
 Sanitary Design and Construction of Food Processing and Handling Facilities
 Sanitary design principles AMI ( American Meat Institute)
 HNA Standard: Sanitary Design Guidelines: Facility Principles & Criteria, Version 03-05-2010
 Principles and practices for the safe processing of foods [Heinz-Woodhead Publishing Limited, 1998 ]
 Campden Guideline No 39: Guideline for the Hygienic Design, Construction and Layout of Food
 Processing Factories, 2003
 Campden Guideline No 40: Guideline for the Design and Construction of Floors of Food Production Areas, 2002
 Campden Guideline No 41: Guideline for the Design and Construction of Walls, Ceilings and Services for Food
Production Areas, 2003
 HZ Controlling_Salmonella_in_processing_375001_7 USDA
 Salmonella Control Guidance FDA
 USDA listeria control guidance 2017 UCM535981
 GMA food protection webinar materials 2012
 Kraft Food Hygienic Design Principles Manual
 The hygienic design of chilled food plants and equipment, A comprehensive guide, third edition, Woodhead Publishing
in Food Science, Technology and Nutrition
 Heinz - HYGIENE DESIGN: BUILDING FABRIC DESIGN GUIDELINES
 Quality Assurance and Food Safety Magazine
 Nutri-science Consideration for HZ practices magazine
 American Concrete Pave Association
References

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10. Closing Matter and GQMS Change History Etc.

GQMS Matter

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