Global Ehedg46

DOC No.
46
ASEPTIC AND HYGIENIC FILLING MACHINES –
PLANNING, INSTALLATION, QUALIFICATION AND
OPERATION
April 2018
European Hygienic Engineering and Design Group
EHEDG Secretariat
Lyoner Str. 18
60528 Frankfurt, Germany
Tel.: +49 69 66 03-12 17 or -14 30

Fax: +49 69 66 03-22 17 or -24 30
E-Mail: secretariat@ehedg.org
Web: www.ehedg.org
THE ENGLISH VERSION OF THIS EHEDG DOCUMENT IS THE OFFICIAL VERSION. THE RESPONSIBILITY
FOR THE PREPARATION, DEVELOPMENT AND ISSUANCE OF SUCH GUIDELINES LIES WITH EHEDG.
DUE TO THE TECHNICAL AND GENERAL NATURE OF THE GUIDELINES, EHEDG MAY NOT ASSUME
ANY LIABILITY RESULTING FROM THE INTERPRETATION, APPLICATION OR USE OF SUCH GUIDELINES.
EHEDG GUIDELINES ARE DEVELOPED IN CO-OPERATION WITH 3-A SANITARY STANDARDS.
DOC No. 46 ©EHEDG 2 of 40

Contents Page
Summary ............................................................................................................................................................. 5
Introduction ......................................................................................................................................................... 5
1 Objectives and scope ............................................................................................................................ 5
2 Prerequisite References ....................................................................................................................... 6
2.1 Normative References ........................................................................................................................... 6
2.2 EHEDG Guidelines................................................................................................................................. 6
3 Definition of Terms ................................................................................................................................ 6
4 General Considerations ........................................................................................................................ 8
4.1 Production Environment ....................................................................................................................... 8
4.2 Design Specification ........................................................................................................................... 10
4.3 Qualification Sequence of Hygienic Filling Machines ..................................................................... 13
4.4 Quality Assurance and Maintenance ................................................................................................. 15
4.5 Change Management (Products and Packaging) ............................................................................. 22
5 Special Considerations ....................................................................................................................... 22
5.1 Selection of Hygiene Class ................................................................................................................. 22
5.2 Design Characteristics of Hygienic Filling Machines ...................................................................... 23
5.3 Microbiological Qualification Tests Class IV and V ......................................................................... 25
6 References ........................................................................................................................................... 28
Keywords for training programs with reference to hygienic filling plants ................................. 31
New Packaging Decision Tree ......................................................................................................... 32
New Product Decision Tree ............................................................................................................. 33
Unilever modified 3-drop-test .......................................................................................................... 34
Risk based sampling plan ................................................................................................................ 38
Minimum decontamination requirements for filling machines of VDMA hygiene classes
IV and V .............................................................................................................................................. 39

Aseptic and Hygienic Filling Machines – Planning, Installation,
Qualification and Operation*
April 2018
©EHEDG
Dr. Peter Golz** VDMA, Germany
Prof. Dr. Bernd Wilke Bosch Packaging Technology, Germany
Dr. Patrick Engelhard Krones, Germany
Rudolf Flörke SIG Combibloc, Germany
Cock Kranenburg Stork Food & Dairy Systems, Netherlands
Dr. Fritz Lembke Tetra Pak, Germany
Tineke Mostert Unilever, Netherlands
Admira Mesic Tetra Pak, Sweden
Dirk Nikoleiski Mondelez International, Germany
Dr. Viivi Nuottajärvi Lamican, Finland
Dr. Gunnar Rysstad Elopak, Norway
* Report prepared by the Working Group “Packaging Machines” of the European Hygienic Engineering
& Design Group (EHEDG)
** Chairman

Summary
This document covers aspects to be considered while planning, installing, qualifying, and operating hygienic
filling machines for liquid products (foods as well as beverages) to manage and monitor hygienic risks
related to this kind of machines. As guide for this updated guideline on Packing Machines, the VDMA
categories of hygienic filling machines (see Table 1) are used.
This document replaces EHEDG documents 3, 11 and 21.
Introduction
This EHEDG Guideline on hygienic and aseptic filling machines for liquid products (foods as well as
beverages) replaces EHEDG documents 3, 11 and 21. It gives guidance to manage and to monitor hygienic
risks related to this kind of machines (Section 4 – General Considerations). In Section 5 – Specific
Considerations - this guideline gives guidance for selecting the appropriate machine class and determines
the machine class according to design principles implemented. Furthermore Section 5 includes a summary
of decontamination requirements and gives an overview on microbiological tests used when qualifying
hygienic filling machines. This document condenses and complements work results of different EHEDG and
VDMA expert groups.
The technical characteristics of hygienic filling machines for foods and beverages differ with respect to the
intended operation. In this EHEDG Guideline the VDMA classification scheme is adopted. The reason for
implementing numbers ranging from I (lowest hygienic demands) to V (highest hygienic demands) is to allow
for a generic description of hygienic filling machines while avoiding any association with brand names of
machine manufacturers.
Typical applications for class I machines are among others non-vulnerable products, not pasteurized and
distributed at ambient temperature.
Typical applications for class II machines are among other products, vulnerable for microbiological spoilage
(no spore outgrowth or pathogen growth possible), partially or completely pasteurized and to be distributed
at ambient temperature.
Typical applications for class III machines are among others high acid fresh products to be distributed in the
cold chain and low alcohol beverages, not pasteurized distributed at ambient temperature.
Typical applications for class IV machines are among others commercial sterile high acid products for
ambient distribution, low and high acid fresh products for extended shelf life (ESL) in the cold chain, and cold
filled non-carbonated soft drinks distributed at ambient temperature.
Typical applications for class V machines or aseptic filling machines are UHT dairy products, non-carbonated
ice-tea, and dairy containing coffee drinks all distributed at ambient temperature.
Depending on shelf life policy and product characteristics filling of low acid ESL products with Hygiene Class
V machines may be considered. More examples including values for minimum shelf life are given in VDMA
Document No. 2.
1 Objectives and scope

This document covers aspects to be considered while planning, installing, qualifying, and operating hygienic
filling machines for liquid products (food as well as beverages) to manage and monitor hygienic risks related
to this kind of machines. As guide for this updated guideline on Packing Machines, the VDMA categories of
hygienic filling machines (see Table 1) are used. Physical risks are not in the scope of this document. For
general aspects of integration of hygienic and aseptic systems, EHEDG Document 34 may be referred to.

2 Prerequisite References
The following legislation, standards, and guidelines are prerequisite for this guideline:
2.1 Normative References
DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 on
machinery, and amending Directive 95/16/EC (recast)
REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27

October 2004 on materials and articles intended to come into contact with food and repealing Directives
80/590/EEC and 89/109/EEC
COMMISSION REGULATION (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for
materials and articles intended to come into contact with food (Text with EEA relevance)
EN 1672-2:2005+A1 2009 Food processing machinery - Basic concepts - Part 2: Hygiene requirements
2.2 EHEDG Guidelines
EHEDG Doc. No. 8: Hygienic design principles
EHEDG Doc. No. 9: Welding stainless steel to meet hygienic requirements
EHEDG Doc. No. 10: Hygienic design of closed equipment for the processing of liquid food
EHEDG Doc. No. 13: Hygienic design of equipment for open processing
EHEDG Doc. No. 32: Materials of construction for equipment in contact with food
EHEDG Doc. No. 35 Hygienic welding of stainless steel tubing in the food processing industry
EHEDG Doc. No. 39: Design principles for equipment and process areas for aseptic food manufacturing
EHEDG Doc. No. 47: Guidelines for air handling systems in the food industry – Air quality control for building
ventilation
3 Definition of Terms
Aseptic process
A process using equipment sterlized before use, and which, in running conditions, is protected against
recontamination by microorganisms.
Commercially sterile product for filling

Product free of viable microorganisms having public health significance, as well as microorganisms of
nonhealth significance capable of reproducing in the food under normal nonrefrigerated conditions of storage
and distribution.
Commercially sterile packaging and accessories

Packaging and accessories free of viable microorganisms having public health significance, as well as
microorganisms of nonhealth significance capable of reproducing in the food under normal nonrefrigerated
conditions of storage and distribution.
Note: Definition based on the FDA definition in 21 CFR 113. 1
1 “Commercial sterility” of equipment and containers used for aseptic processing and packaging of food means the
condition achieved by application of heat, chemical sterilant(s) or other appropriate treatment that renders the equipment
and containers free of viable microorganisms having public health significance, as well as microorganisms of non-health
significance capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.

Food allergen
Any normally harmless substance of food that causes an immediate allergic reaction in a susceptible person.
Note: Food allergens are almost always proteins although other food constituents, such as certain additives,
are known to have allergenic (allergy-causing) properties.
Hygienic filling machines of class V (aseptic filling machines)

Packaging machines which fill a commercially sterile product having a pH > 4.6 free of contamination into a
package usually sterlized on the machine.
Note: In order to achieve this, high demands are set on the effectiveness of the sterlizing devices for the
packaging, the interior of the machine and the product-handling parts (see VDMA document Food
Processing Machinery and Packaging Machinery No. 11). Thus, in packaging sterlization a count reduction
of test microorganisms suitable for the sterlization method in question of at least four powers of ten is
considered necessary.
Aseptic filling machines are typically used for filling products having a pH > 4.6 which should have a
relatively long shelf life without refrigeration.
Hygienic filling machines of class IV

Packaging machines which fill a commercially sterile product having a pH ≤ 4.6 free of contamination into a
package usually sterlized on the machine
Note 1: In order to achieve this, high demands are set on the effectiveness of the sterlizing devices for the
packaging, the interior of the machine and the product-handling parts, but these are less demanding than for
class V machines (see VDMA document Food Processing Machinery and Packaging Machinery No. 10).
Note 2: In some products with a pH value in the range of 3.8 < pH ≤ 4.6 spore building product spoiling
microorganisms may grow. If these microorganisms are of relevance for the product to be filled, UHT-
treatment of the product and filling with class V machines will be necessary.
Hygienic filling machines of class III

Packaging machines which fill a microbiologically sensitive product meeting the technical requirements
outlined in VDMA Document No. 2.
Note: see section 5.2 for technical requirements
Hygienic filling machines of class II

Packaging machines which fill a microbiologically sensitive product meeting the technical requirements
Hygienic filling machines of class I

Packaging machines which fill a microbiologically non-vulnerable product meeting the technical requirements
Inoculation
Artificial infection of a germ carrier with test microorganisms.
Microbiological challenge test

Test for checking the decontamination power of filling machines by artificially inoculating with a test
microorganism. the region being investigated at the time – packaging sterlization, sterile zone in the interior
of the machine, product-handling parts.
Sterile
In the sense of this guideline: Free of microorganisms capable to reproduce under conditions of intended
operation:
Conditions of intended operation of filling machines of class IV:
Product to be filled: pH ≤ 4,6 (high acid products)
Distribution and storage at ambient temperature

Conditions of intended operation of filling machines of class V:
Product to be filled: pH > 4,6 (low acid products)
Distribution and storage at ambient temperature
Sterile test
Test for checking the microbiological safety of a filling line under production conditions.
Note: Passing the sterile test is normally regarded as a precondition for starting up commercial production.
Sterile zone in the machine interior

That region in the interior of an aseptic filling machine which after completion of sterlization must be kept free
of microorganisms in order to prevent recontamination of the commercial sterile product during filling.
Test microorganism
Microorganisms used to check the performance of sterlization devices.
Note: Test microorganisms should exhibit a high and documented resistance to the decontamination method
being investigated. They should also be easy to detect and present no hazard to health. The description of a
test microorganism should contain the following characteristics: name, D value, precise designation of strain
(ATTC No. or DSM No.) and batch number (in the case of ready-made spore suspensions).
4 General Considerations
This section addresses general aspects to be considered when planning, installing and operating hygienic
filling machines. Focus is set on topics proven relevant for the hygienic performance of filling machines.
Reference is made to other EHEDG Documents as far as possible.
4.1 Production Environment
For general aspects in relation with production environment of hygienic processing and packaging equipment
please refer to EHEDG Guideline No. 44 on "Hygienic Design Principles for Food Factories". Focus in this
section is set on intersection issues relevant for the hygienic performance of filling machines.
4.1.1 Zoning
Depending on the vulnerability of the product for environmental contamination, the filling machine may be
installed in either a low, medium or high hygiene area following EHEDG Guideline 44 section 7.1.2. In
addition to microbiological hazards physical and chemical hazards from the production environment should
be considered. It is recommended to document deviations from the hygiene area concept and if necessary to
implement appropriate measures to assure the hygiene standard needed.
4.1.2 Utilities, media supply and product supply
Before delivery of the filling machine, both the supplier and user should agree on:
— Product supply lines (supply line pressure, temp. and pressure during sterlization and cleaning, diameter
feed line, max. capacity filling machine, …)
— Method of cleaning and disinfection/sterilization (cleaning agents, supply line pressure (steam, liquids),
connection to filling machine, pressure loss in filler, capacity needed, …)
— Water (water type, chloride, hardness, temperature, supply line pressure, supply line capacity,
consumption of machine, …)
Note: If aseptic machines use peracetic acid to sterilize the packaging material, “rinsing” with sterile
water must follow. The generation of this water requires a great deal of technical effort.
— Steam (steam type, quality, volume, temperature, condensate, pressure, due point, supply line pressure,
supply line diameter, supply line capacity, …)
— Compressed Air (air type, quality, volume, temperature, condensate, pressure due point, supply line
pressure, supply line diameter, consumption of machine, …)
— Inert Gas (gas type, quality, volume, temperature, …)
— Cooling Media (media type, volume, temperature, …)

— Electrical power (net type, voltage, control voltage (including tolerance), Frequency, maximum allowable
power cuts, components, total connected load, consumption of machine, …)
If several filling lines are operated at the same time it should be assured that needed supply of utilities is
sufficient. It is recommended to prepare worst case scenarios to evaluate whether the capacity of utilities
and media is sufficient.
Pressure shocks in feed lines might violate the sterile status of the plant by temporary leakages in pipe
connections which couldn't be detected afterwards (relevant for class IV and V machines).
Condensate in compressed air pipes might be a source of microbial contamination. Sanitizing of the pipe
system and monitoring of sterile filters in compressed air pipes on a regular basis is strongly recommended.
4.1.3 Installation of product and feedlines
All product and feed lines should be designed and installed according to hygienic design principles, as stated
in EHEDG Guideline No. 8 or EN 1672-2.
In existing production environments field inspection to check for installation and design faults is strongly
recommended. Detected faults should be corrected prior to installation of the filling machine.
Whenever components are added to or relocated within a feed or supply lines It is recommended that a
thorough hygiene assessment to be performed.
VDMA Document No. 4 provides information on weak points in installation of product and feed lines in
aseptic plants. This document concentrates on risks, based on planning and installation faults. The weak
points are found normally in a form of product deposit that is difficult to remove, thereby further increasing
the magnitude of the cleaning problem.
4.1.4 Environmental Air Quality
General requirements for ventilation systems in hygienic food processing plants can be found in EHEDG
Guideline No. 44 Chapter 9. It is recommended that 'air should flow from a higher to lower hygienic zone
classification and from lower to higher dust loaded areas. Usually an air pressure differential between the
zones meets this requirement. The process plant should be operated under a slightly positive pressure (2-5
Pa) in order to prevent ingress of unfiltered air. To meet different hygienic requirements (zone classification),
random airflow between floors via stairways, lifts etc. must be prevented by installation of air lock systems.'
Further through-traffic and ventilation of the filling area by open doors and open windows should be avoided
in order to sustain the pressure differential between filling area and adjoining areas.
EHEDG Guideline No 47 gives recommendations for planning, hygienic design manufacture and installation
as well as guidance when upgrading existing systems.
4.1.4.1 Special considerations with respect to filling machines of hygiene class IV and V
In case the risk assessment identifies the ventilation system as a potential source of a recontamination it is
strongly recommended to monitor the microbial load of inlet air and outlet air.
Weather conditions might have an impact on the performance of the ventilation system. Adverse conditions
may adversely affect the required pressure differential between the sterile zone of the filling machine cabinet
and adjoining zone respectively between the machine cabinet and the environment of the filling machine.
When designing the ventilation system, the emission of vapours (e.g. H2O2, peracetic acid) into the room
from finished packages should also be considered (in the case of sterlization of packaging materials by H2O2
or peracetic acid)
Adequate frequency of air change is required - especially in case of use of chemical agents for
decontamination procedures - to meet work place exposure limit (WEL) (at least twofold to max. fivefold air
change per hour, the latter in the case of high contamination levels).

Work Place Exposure by chemical agents for decontamination procedures might be increased when running
several filling lines in the production area.
4.1.5 Drainage
General requirements on hygienic drainage systems in food factories can be found in EHEDG Guideline No.
44 Chapter 8. Drainage systems should be designed according to hygienic design principles. Generally, the
drainage system should be positioned as near to the fluid source as possible while ensuring accessibility for
inspection, cleaning and maintenance. For areas with CIP systems it is recommended that water is directed
into the drainage system, e.g. by a pipeline. Nevertheless, to avoid waste water backflow and to protect line
hygiene, air gaps are necessary.
When installing filling machines in an existing production environment it is recommended to check by field
inspection whether the capacity and design of the drainage system is adequate for the application. If
necessary, the drainage system should be adjusted to meet specified requirements. Further, the location of
gullies and channels should be checked by field inspection. If necessary, to avoid coverage, gullies and
channels should be relocated prior to installation of the filling machine.
4.1.6 Machine accessibility
Production environment should provide sufficient space and heights required for proper operation, cleaning,
inspection, maintenance and clearing of blockages as well as for supply of packaging material and
packaging means.
Field inspection is strongly recommended to detect any barriers and mounting that might be relevant for
design and installation of the filling machine.
Ladders and platforms for inspection might be built as extension to the machine after installation of the filling
machine. These extensions should be considered when calculating space and height available for machine
installation. For hygienic design, see EHEDG Doc.44 paragraph 8.16.
4.1.7 Storage and handling of packaging material
Sufficient storage space, separated from production area, should be available to store packaging material
and packaging means at controlled ambient conditions. As storage conditions might affect processing
properties of packaging material and packaging means it is recommended that storage capacity is sufficient
to ensure primary packaging material to be stored at controlled ambient conditions equal to the filling area at
least for 24 hours prior to processing.
If the filling area is not separated from other production areas procedures must be in place to assure
appropriate handling of packaging material to maintain the hygiene requirements needed in the filling area. .
Secondary packaging should be done in rooms separated from the filling area as secondary packaging
material should not enter the filling area for hygiene reasons.
4.2 Design Specification
This section sets the focus on issues to be cleared in the design phase specific to hygienic filling machines.
4.2.1 Production environment
The product environment must meet the requirements for the intended use of the filling machine.
Specifications should cover but are not restricted to the aspects stated in section 4.1.
A field inspection of the existing production environment is highly recommended. Measures necessary to
upgrade the production environment to meet the needs for hygienic filling should be implemented. This
should be completed before installation of the filling machine.

4.2.2 Product characteristics
Product characteristics of the product to be filled and cleaning procedures needed must be known for correct
design of the filling machine. At least the following aspects must be specified:
— pH-value
— sugar content/extract content
— alcohol content
— fruit fibres, particles and pulp
— viscosity
— corrosive potential
— protein and fat content
— flavourings
— allergens
VDI 4066 Part 1 and Part 4 are discussing the topic product characteristics in more detail
4.2.3 Packaging materials and packaging aids
If packaging decontamination is required sterilization tests should be performed as early as possible in the
planning process as the results of these tests may have an impact on the design of the package and/or on
the design of the filling machine. The tests and actions associated with sterlizing the packaging and
packaging aids (e.g. closures) that are of particular significance for the microbiological safety of the filling
process are listed below.
1. Investigate sterilizability (for preformed containers and closures delivered non-sterile)

2. Determine the maximum admissible initial germ count (if appropriate, differentiated by types of
microorganisms)
3. If appropriate, investigate the effects of the forming processes upstream from filling on the material
properties and dimensional tolerances of the packaging
4. Investigate the effects of the sterlization agent on the material properties and dimensional tolerances of
the packaging
5. Investigate the effects of dimensional and recipe tolerances on the tightness of packages (closures, lids)
6. Determine material properties, dimensions and dimensional tolerances (technical specification of the
packaging)
7. Determine the requirements on the packing, storage and provision of the packaging
8. Verify the suitability of the packaging by means of a sterile test. Release the technical packaging
specification.
9. Document changes in the technical packaging specification after the sterile test has been done.
VDMA Document No. 16 (2010) may be consulted for information on test criteria for specific packaging with
particular relevance for filling machines of Hygiene Classes IV and V which might be included in packaging
specification.
The change documentation should firstly serve to raise awareness that amendments to the technical
specification can have an influence on microbiological process reliability. The documentation secondly helps
to clarify causes in case microbiological problems occur.
4.2.4 Hygienic design requirements
The design of hygienic filling machines must be according hygienic design principles outlined in EN 1672-2,
EHEDG Doc. No. 8 and further EHEDG Documents of relevance, e.g. EHEDG Documents 9, 10, 13, 16, 32,
35 and the forthcoming guideline on CIP-systems. For filling machines of hygiene class IV and V filling
commercial sterile products also EHEDG Doc. No. 39 may be consulted. Deviations from hygienic design

principles, if necessary, must be written down in the technical documentation. EHEDG Document No. 32 and
DIN 10528 may be consulted with respect to selection of construction material intended for the contact with
food.
For the assessment of the hygienic design of components further specific EHEDG Documents may be
consulted.
It is recommended not to integrate sampling valves in hygienic filling machines of hygiene class V as each
valve in a product line represents an additional hygienic risk. If sampling valves are considered necessary in
a hygienic class V machine, planned integration in the initial concept is considered a lower risk compared to
integration of sample valve in an existing filling plant. In that case EHEDG approved or alike sampling valves
are recommended.
4.2.5 Cleaning
The product conducting surfaces of the filling and dosing unit should preferably be CIP-cleaned. For hygienic
design-requirements with respect to CIP-systems see EHEDG Guideline on CIP-installations (forthcoming).
A compilation of aspects of interest with respect to CIP/SIP-installations in aseptic filling lines is included in
Krüger/Zschaler (2010).
The direct environment of the filling and dosing unit may cause contamination of the product if not
adequately cleaned and decontaminated. Special attention may have to be paid to the means for transport of
the filled packs (such as conveyor belts or chains) to prevent them from conveying spilled product through
the machine.
Preferably, the design should allow also in-place cleaning of indirect product contact surfaces, without any
dismantling. If this is not possible, each part of the machine must be accessible for cleaning manually, with
or without dismantling. Decontamination must take place after reassembly. If dismantling and reassembling
are needed, this should preferably be so easy that it can be done without tools. It is recommended that the
machine is designed such that cleaning of the surrounded area does not significantly contaminate the
machine (e.g. by using screens).
If an automatic cleaning in place is applied, moving parts must be activated during cleaning or be placed in a
cleaning position.
4.2.6 Decontamination
4.2.6.1 Machine Decontamination
For hygienic class I and II machines a decontamination step of only the product contact areas, to inactivate
vegetative microorganisms (pasteurisation), might be needed. This depends on the product to be filled.
Hygienic class IV and V machines require complete system sterility as they are used for commercially sterile
products. Class III machines need a complete system pasteurization step to inactivate vegetative micro-
organisms.
For decontamination of machine parts typically thermal and chemical procedures are applied.
Before the systems are put back into operation, also the filling area (machine interior) has to be sterilized
(class IV and class V machines only). The machines have special equipment for this, e.g. hydrogen peroxide
steam injection at high temperature. Special attention must be paid to the concentration and quantity of the
H2O2 used for this sterilization.
After completion of the sterilization cycle signal exchange to SIP must be made in order to guarantee that the
machine is ready in a sterile state.
4.2.6.2 Packaging Decontamination
Hygienic filling machines of class III, IV and V are equipped to decontaminate packaging and packaging
means. Typically, chemical contamination by hydrogen peroxide or paracetic acid, physical procedures (e.g.
UV-beam, E-beam or plasma systems) or thermal procedures (e.g. by means of saturatedized steam) are
used. Appropriate design measures to meet machine safety requirements and Occupational Exposure Limits

(in case of chemical decontamination) have to be adopted. Special attention is required to remove chemical
residuals from product contact surface when chemical procedures are applied.
4.2.7 Signal exchange between individual subsystems of a hygienic plant
A hygienic filling plant consists of several subsystems like sterile tank, UHT unit/heater and filling machine,
each of which has its own control system and an integrated or assigned CIP unit. Faults in the exchange of
signals between the individual subsystems of a hygienic plant are a possible cause of incidences of
microbiological contamination. This potential for faults can be prevented by determination of the subsystem
boundaries and a clear definition of the signals to be exchanged between the subsystems. VDMA Document
No. 5 (2002) may be consulted for examples of safe exchange of signals.
4.3 Qualification Sequence of Hygienic Filling Machines
For hygienic filling machines of class III, IV and IV a structured qualification process in five phases is
recommended. Phases 2 through 4 may overlap in time and should be coordinated. Successful completion
of the preceding phase is a prerequisite for the completion of the subsequent phase. Phase 5 cannot be
started until successful completion of phase 4. The successful completion of each phase must be
documented appropriately.
Consensus on test plans, test procedures, acceptance criteria, and responsibilities should be agreed
between all parties involved. This is to ensure that potential difficulties are identified at an early stage.
This qualification sequence may also be adopted for machine classes I and II restricted to the items
appropriate for the respective class of machines.
4.3.1 Phase 1: Approval of technical specification (as per design qualification, DQ)
The approved technical specification should consider the aspects outlined in section 4.1 and 4.2 of this
document.
Document revision management should be applied following approval of technical documentation.
4.3.2 Phase 2: Checking compliance with the technical specification before delivery (corresponds
to factory acceptance test, FAT)
Measures may include but are not restricted to:

— Functional tests of integrated devices
— Check of measuring sensors (performing logical checks)
— If necessary: Checking access to sterile zone of machine interior without violating sterile conditions (e.g.
by using gloves)
— If necessary: check safety controls to monitor integrity of sterile conditions
— Assessment of appropriate hygienic design
— Material certificates where necessary and agreed on
— Test on integrity of air filters of machine cabinet (if appropriate)
Deviations from technical specification should be documented and corrective action taken if necessary.
4.3.3 Phase 3: Checking correct installation in accordance with specification (corresponds to

installation qualification)
A field inspection to verify the specified production environment is recommended. Deviations from
specification should be documented. Optimisation considered necessary should be completed prior to
installation of the filling machine.
Correct installation of the filling machine should be checked according to a test plan and verified with
appropriate measures.

— Checking connections to supply line
— Checking connected loads (quantity/quality)
— Checking accessability of drains
— Checking accessability of machine after installation for cleaning, operating, and maintenance
Deviations from technical specification should be documented and corrective action taken if necessary.
4.3.4 Phase 4: Completion of technical and microbiological performance tests (corresponds to

operation qualification, OQ)
Tests to be performed according to an agreed test plan and according to the agreed acceptance criteria.

— Functional test of machine subsystems as per test plan
— Functional test of entire machine system using water or agreed product (prerequisite for microbiological
challenge tests)
— Check on chemical residuals on packaging materials (if appropriate)
— Microbiological challenge tests (if agreed on; see section 5.4.1; filling machines of hygiene class IV and
V)
— Cleaning validation
— Test on bacteria tightness if appropriate (EHEDG Doc. 11)
Technical and microbiological performance tests may be done at the machine manufacturer's site if feasible
and appropriate.
Examples for checklists for tests plans for the microbiological inspection and acceptance of filling machines
are included in VDI 4066-1 Annex C (filling machines for beverages) and VDI 4066-4 (filling machines for
dairy products)
For the assessment of cleanability the general principles of cleaning validation in the food industry in EHEDG
Doc. 45 may be applied.
A test for wettability, e.g. a Riboflavin test as described in VDMA Information Sheet "Riboflavin-test for low
germ or sterile process technologies" may be used to check for weak spots and effectiveness of CIP
cleaning of the interior of the machine cabinet.
4.3.5 Phase 5: Clearance of plant for commercial production (corresponds to performance

qualification, PQ)
Tests to be performed according to an agreed test plan and according to the agreed acceptance criteria.

— Adjustment and optimisation of machine parameter settings according to product and packaging range
covered by the intended use.
— Selection of test product and test packaging that is representative for the intended use
— Performing of a sterile test (see section 5.4.2, (filling machines of class IV and V only)
— Microbiological assessment of product quality at the end of intended shelf life of test production (Filling
machines of hygiene class III only)
— Compilation of operation procedures to ensure food safety within the filling machine (safe parameter
settings, cleaning, maintenance, preparation of a sampling plan for accompanying microbiological
testing),

— Declaration of clearance of machine for commercial production (successful completion of phase 5)
— Machine operators and cleaning personnel have been trained on the proper operation and cleaning of
the machine (see section 4.4.10).
If changes are required during the course of phase 5, phase 4 should be completed again
A microbiological assessment of a test production run might be part of an acceptance test. (Machines of
hygiene class IV and V)
Following the successful completion of phase 5 of plant qualification further measures can be taken to
provide further assurances of the integrity of filling machines in hygiene class IV and V. (see section 5.4
4.4 Quality Assurance and Maintenance 2
4.4.1 Pre-Operational Quality Checks
Before production starts the machine operator should become familiar with the proper condition of the
machine. For this, suitable checklists should be available. The machine should preferably be constructed
such that deviations from the desired state are automatically and independently reported. Tests done as well
as any deviations from the required state should be documented.
4.4.1.1 Packaging materials
Only packaging materials and packaging means needed for supply of the filling machine should be stored
near the filling machine. Pallets and outer packaging should meet appropriate hygienic conditions to be
agreed on by both machine manufacturer and machine user. Nevertheless, it is recommended to remove
covers or outer packaging material outside of the filling area.
Use of packaging material in line with specification is essential for smooth operation of the filling machine. In
the case of filling machines of hygiene classes IV and V particular care has to be taken that the specification
criteria identified as critical for the sterilizability of the packaging materials in the course of validation are
adhered to.
A low initial germ count of the packaging to be filled and packaging aids is essential for filling commercially
sterile products free of contamination.
Empirical investigations have shown that it is not so much the manufacturing process itself that can cause a
high germ count on the inner and outer surfaces of the packaging, but rather how the manufactured
packaging material is handled in the packaging production plant and in the filling plant. The aim should
therefore be to preserve the generally low germ count following on directly from manufacture by means of
hygiene measures and suitable packing. Examples of possible sources of contamination are the ambient air
(ambient air drawn in when cooling containers; contamination from the electro-static adherence of particles
of dust) and manual handling of packaging (e.g. manual stacking of cups in cartons).
It is therefore recommended to include the in-plant packing logistics in the hygiene management system.
This applies not only to packaging and packaging aids which come into direct contact with the product, but
also applications as pouring aids, which could infiltrate the sterile zone inside filling machines and possibly
need to be sterilized. The following actions are recommended:
— Store the packaging material in its original packing

— Cover the packaging near the filling machine
— Hygiene training for personnel that is handling the packaging
— Cover/stow away unused packaging at the end of production
2 This section is drafted with reference to sections 3-12 of VDMA Document No. 3 (2008)

— Process instructions for handling the empty containers left in the machine at the end of the production
must be in place (machine manufacturer's operating instructions).
The storage conditions, the temperature and the moisture content of the packaging material can influence
the processing properties of the material. In the case of deep-draw machines, for instance, a low
temperature in the core of rolls of film or foil in winter can lead to problems during forming in the Form Fill
Seal (FFS) machine. Manufacturers of machinery therefore formulate storage suggestions and
recommendations for "acclimatising" the packaging before filling.
VDMA Doc. No. 16 may be consulted for more information.
Information about microbial load of packaging material might be found in the sources mentioned below:
— The Fraunhofer Institute for Process Engineering and Packaging (IVLV) in Freising published guidelines
for microorganism carriage in packaging and packing substances made of non-absorbent materials (see
Hennlich (2004)).
— Requirements on microorganism carriage in milk packaging can furthermore be found at IDF (Bulletin
300/1995 - Technical guide for the packaging of milk and milk products – Third edition) and FDA (PMO
2007: Appendix J - Standards:Fabrication of Single-Service Containers & Closures for Milk and Milk
Products Grade "A" Pasteurized Milk Ordinance (2007 Revision)).
— ABMI has published guidelines for drinks packaging (Appendix 2 of 'Common Aseptic Validation
Protocol'; ABMI (2010); http://www.abm-industry.org/).
4.4.1.2 Utilities and media supply
Prior to the start of production, the utility connections of the machine should be controlled with regard to the
following criteria:
— correct connection
— quality according to requirements (e.g. concentration of cleaning and sterilization media)
— amount provided (e.g. adequate line pressure)
4.4.1.3 Product being filled
Product characteristics critical for the performance of the filling machine should be monitored. Only product
in line with the characteristics approved for commercial production should be filled.
4.4.1.4 Readiness for operation
It is important that the machine operator ensures prior to production
— that all scheduled maintenance or necessary repair work has been done,
— that all critical machine functions for hygienic production has been checked.
— that the machine has been cleaned successfully and if necessary has been sterilized successfully
Test of critical machine functions can be performed by automatic self-testing of the machine or manually.
Dependent on the decontamination process checks in empty packages for residues of sterilization medium in
accordance with machine manufacturer's instruction are recommended. VDMA FS No.1 (2011) contains test
procedures on this.
Any lack in functionality should be documented and be corrected before production is started.
4.4.2 Quality-maintenance measures and checks during production
4.4.2.1 Machine settings
All key operating parameters defined by the machine manufacturer must be compared with the respective
target values during production. For this purpose, filling machines of hygiene class V must be equipped with
appropriate measuring, control and safety devices so

— that all variables of importance for microbiological safe operation in the packaging machine can be
adequately measured and controlled
— that all operating disturbances in the packaging machine affecting product quality are displayed or
intervention for corrective action is initiated.
The measuring, control, and safety devices must be protected against unauthorized intervention.
Unless the necessary checks and the documentation of deviations from specified target values are
monitored and captured automatically, test instructions and suitable checklists must be given to the machine
operator.
For filling machines of hygiene classes I to IV lower requirements are imposed on the automatic monitoring
of operating parameters. Nevertheless, control of the operating parameters related to the hygiene quality of
the product is recommended.
4.4.2.2 Emission of disinfection agent
Legal regulations and WELs (Workplace Exposure Limits) must be observed. Information on international
maximum allowable concentrations is provided by the GESTIS database. GESTIS - International limit values
for chemical agents (Occupational exposure limits, OELs) GESTIS is available for research at no cost under
the following link: http://www.dguv.de/ifa/GESTIS/GESTIS-Stoffdatenbank/index-2.js .
4.4.2.3 Examination of production result
Sampling of filled packs should be performed according to a specified sampling plan, which defines who is to
take which samples in what quantities and how often. A risk-based approach for monitoring the
microbiological quality of the filled product as outlined in section 5.4.4 is recommended.
To identify machine malfunctions as early as possible the machine operator should perform simple tests to
check package and product quality during sampling. Measures may include but are not restricted to:
— Visual inspection of package (evaluation of appearance)

— Check of sealing areas
— Leakage test (visual evaluation, ink test, conductivity measurement)
— Weight and volume check
— Test for residues of sterilization agent in the product
VDMA Doc. 3 (2011) states an example for a sampling plan for aseptic filling:
— immediately after the start of production, and then every 30/60 minutes: 2 samples;
— additionally, 12 retained samples per production batch (beginning, middle, end of production), possibly
as control samples in the case of claims or complaints;
— additionally, at least 2 samples after machine stop.
All half-hourly and hourly samples as well as special samples are incubated at suitable temperatures for
suitable incubation periods (e.g. at 30 °C for 3 days) and microbiologically tested. The retained samples are
kept at ambient temperature or at chilled temperatures until the end of the declared product shelf life.
So that in the case of unsterility of packages possible causes may be narrowed down, the possibility of
sampling immediately upstream the interface between the process system and the packaging machine
appears sensible. Such a sampling point itself, however, is a further unsterility risk. Since additionally due to
the low sample volume no reliable results are to be expected setting up such a sampling point is not
recommended.
The only possibility of reliably verifying the absence of microorganisms that can spoil the product is the so-
called tank storage test (i.e. storage of heat-treated product in a sterile aseptic tank at appropriate growing
conditions; any microorganisms still present will multiply and completely spoil the product and so easily
demonstrate the unsterility of such spoiled product).

The reliable identification of sporadic faults in the microbiological functions of aseptic packaging machines on
the basis of random sampling is virtually impossible.
The systematic capture and analysis of complaints has proved to be a useful instrument in practice for
identifying causes of faults.
4.4.2.4 Measures in the event of interruption of production
Instructions of the machine manufacturer should be observed. In the case of hygienic filling machines of
classes IV and V production stoppages should be safeguarded in such a way that the sterile state of the
machine is not altered or the need to clean and sterilize the machine is indicated to the operator.
4.4.3 Quality-maintenance measures and checks after end of production
4.4.3.1 Cleaning/sterilization
Cleaning and, if needed, sterilization in accordance with the cleaning plan to be drawn up by the plant
operator in agreement with the machine manufacturer. Measures may include but are not limited to:
— Cleaning/sterilization of product-conveying parts as well as of the sterile section of the machine

— External cleaning and, where applicable, disinfection
— Cleaning of machine surroundings
4.4.3.2 Machine inspections
Systematic machine inspections make the identification of irregularities easier and thus help to determine
any functional faults at an early stage. Measures may include but are not limited to:
— Filling levels of operating resources to be read off and documented

— Consumption values to be determined
— Inspect for lubricant leakages that could contaminate empty packages (e.g. relevant for blow moulding
machines)
4.4.3.3 Packaging materials / auxiliary packaging materials
Preventive measures against soiling of packaging material are recommended (e.g. covering and, if need be,
storage)
4.4.4 Quality-maintenance measures in the event of operating malfunctions
Aseptic packaging machines are equipped with extensive control functions to ensure, as a rule, that the
machine is shut down in the event of technical faults or disturbances and that production cannot be resumed
until the cause of the fault has been eliminated and the performance of specified further measures to ensure
product safety has been acknowledged. At the same time the state of the machine at any moment (ready for
operation, not ready for operation, sterile, unsterile …) should be displayed to the machine operator.
Despite all the precautionary measures in the technical field it cannot be fully excluded that cases of
unsterility, for example, may occur. Accordingly, as a precaution it is recommended that the machine user
provides instructions for emergency action to prevent unsterile production batches being marketed or at least
to limit the selling on of already shipped batches to an unavoidable minimum. Furthermore, instructions for
action should be issued which promote quick troubleshooting. Employees should be trained in the
instructions for action affecting them so that they are not confronted with an unknown situation in a case of
emergency. The instructions for action should also include careful documentation of fault or failure events.
This documentation serves for analysing the cause of the fault and can be used as the basis of a weak point
analysis to prevent future failures.
It is recommended to proceed as suggested even in the case of non-aseptic filling to restrict the risk of
marketing of products that are posing a risk to health or are not in line with quality standards.

4.4.5 Cleaning / Decontamination
4.4.5.1 Cleaning of product contact surfaces
The operation manual provided by the filling machine manufacturer must recommend effective cleaning and
decontamination procedures and suitable cleaning and decontamination chemicals. Nevertheless, the choice
of cleaning method depends on the type of product to be packed. Margarine and milk, for example, will
require two completely different methods. The choice of cleaning agents also depends on the quality of the
water (in particular the water hardness). The water quality must comply with legal requirements.
The following comments were formulated for filling machines of hygiene classes IV and V. They can be
extended with appropriate modifications to machines of hygiene class I-III.
Filling machines of hygiene classes IV and V are equipped with CIP systems and SIP systems. A long-term
satisfactory cleaning and sterilization result presupposes that the cleaning and sterilization intervals as well
as the maintenance work and intervals determined by the equipment manufacturer are observed.
Intermediate cleaning of the product contact parts may be considered in the context of long production
periods or product changes. In case of intermediate cleaning the commercially sterile status of the machine
has to be maintained.
It should be pointed out that the duration and frequency of cleaning depend on the cleaning agent used, the
temperature of the cleaning agent, the mechanical action and the product to be filled. When the cleaning
agent or temperature is changed, the prescribed cleaning frequency might also have to be changed based
on a risk analysis. It is recommended to consult the machine manufacturer or the supplier of cleaning
chemicals when these alterations are implemented.
Cleaning agents and their temperature have an effect on the wear of elastomers and the corrosion of
product-handling parts. When choosing cleaning agents attention should be paid to the lowest possible
adverse effects. Therefore, recommendations of machine suppliers should be considered
Even if cleaning, sterilization or maintenance regimes are adhered to, cases of unsterility may occur in
practice primarily because of the following cleaning problems:
— gradual formation of deposits on product contact surfaces

— increased soiling after extended downtimes without cleaning
— increased surface roughness of product-handling parts due to corrosion
In addition, a regular review of cleaning results is recommended, e.g. by an examination of the last flushing
water used or by means of UV illumination which can reveal deposits. In the event of deteriorating quality of
cleaning, appropriate instructions for action should be issued to ensure adequate cleaning and to initiate
necessary maintenance operations.
Where a new product is to be filled the food manufacturer should review the existing cleaning regime
whether it is effective also for new product. If proved necessary, the cleaning regime should be adapted. For
Class IV and Class V machines it is recommended to consult the supplier of cleaning agents and/or the
machine supplier when adapting the cleaning regime. Cleaning of machine exterior
Foam or gel cleaning at low pressures are to be preferred. External cleaning with high-pressure hoses will
displace dirt from one place to another, in particular in the form of aerosols. The use of high-pressure
systems is therefore not recommended.
4.4.5.2 Cleaning of production environment
Cleaning procedures should be appropriate for medium respective high hygienic areas of production zones.
Cleanliness of production environment should be checked by visual inspection prior to production.
Microbiological monitoring of production environment is recommended.
Note: See section 4.1.1 for selection of categories of hygienic production areas.

4.4.6 Maintenance
Maintenance covers measures for retaining and restoring the desired state of the machine. This includes:
— Maintenance work to be performed regularly according to a specified schedule in order to retain the
functional capability of the machine
— Inspections to assess the actual condition of parts and components of the machine which are subject to
wear
— Corrective maintenance work for repairing or replacing defective or worn or obsolete parts and
components
It is worthwhile to aim for preventive maintenance, incorporating inspections and corrective maintenance
into regular maintenance activities, in order to recognize and correct weak points reliably before the plant
fails. This objective can also be achieved through regular checks of the complete system independently of
any damage events.
The preventive nature of maintenance is all the more important in aseptic packaging machines as any
maintenance work performed inadequately or too late may result in non-sterility. In practice, the following
have proved to be particularly critical aspects:
— Non-observance of specified maintenance cycles

— fitting of parts not conforming to specification
— use of operating resources not conforming to specifications
— use of overaged elastomers, e.g. gaskets/seals and membrane
The background to such maintenance shortcomings in production companies often takes the form of cost-
cutting exercises or a conflict between production targets and maintenance requirements. This ever-present
conflict of objectives between a reliable product and cost-effective production should be taken into account in
particular when responsibilities are assigned.
Where the specification of operating materials and spare parts is altered, agreement is necessary with the
machine manufacturer concerning any possibly essential amendment of the maintenance instructions.
After any maintenance or repair activities affecting the aseptic section of the machine, the machine must be
cleaned and subsequently sterilized as a matter of principle.
If any changes are made to the sterile system or to product-carrying parts of the packaging machine or in the
case of changes in the process section of the overall plant, a sterile test in accordance with the
manufacturer's specification is recommended before starting up the machine. (Machines of Hygiene Class IV
and V only)
Careful documentation of maintenance and corrective maintenance is an important source of information

when searching for faults in cases of unsterility or when quality problems arise. Moreover, the documentation
provides a basis for the regular updating of the maintenance plan and maintenance instructions.
4.4.6.1 Lubricants
Food grade lubricants of type H1 should be used. EHEDG Guideline No. 23 Part 1 may be consulted for
further information on potential hazards and risks related to the use of food grade lubricants. This guideline
further describes the actions and activities required to eliminate them or to reduce their impact to an
acceptable level.
4.4.7 Documentation
Reliable sets of documentation are an indispensable aid for avoiding faults or failures in the production
workflow and for identifying the cause of faults in the event of product complaints. As a rule documentation
should show who carried out which tests according to which instructions and with what degree of success.
Extraordinary events should be noted separately. Any action initiated for the correction of faults or otherwise

should also be recorded. In doing so responsibilities and completion times should be mentioned and
successful completion recorded.
4.4.8 Personal hygiene
The contamination of packaging by the machine operators is a weakness encountered in practice. Making
staff aware of this problem by appropriate training and the provision of washing facilities as well as
disinfectants in the immediate vicinity of filling machines are considered preconditions for reliably ruling out
this source of errors. This aspect also includes – when permitted by law - the regular renewal of health
certificates.
In connection with personal hygiene psychological factors should not be underestimated. Distinguishing
between hygiene zones and the wearing of special clothing prior to entering the hygiene area demonstrably
arouse hygiene consciousness.
4.4.9 Training
Practical experience has shown that aseptic production can hardly be guaranteed without adequate staff
training. Accordingly, training of all groups of people involved in aseptic production, including management,
is highly recommended. The contents of the training program should be differentiated according to the
specific requirements of the respective target groups. In addition to basic training, regular refresher courses
are recommended.
In non-aseptic filling of microbiologically sensitive products staff training in hygiene is advisable.
With regard to details of a training program for hygienic filling readers are referred to VDI-Richtlinie 4066 Part
2 and DIN 10514.
Typical key-words of a training program are listed in Annex A. Training should be conducted in both theory
and practice.
Note: The need for hygiene training is indicated, for example, in EC Ordinance 852/2004 in relation to food
hygiene in Appendix II, Chapter XII. There it is stated: “Operators of food companies ensure that persons
handling foodstuffs are monitored in accordance with their activity and are instructed and/or trained in
question of food hygiene.” In aseptic production awareness creation going beyond “normal” training is
appropriate.
4.4.10 Special issues
4.4.10.1 Production Run Length
Prolongation of the production period between cleaning/sterilization cycles may increase the risk of
microbiological hazards due to both exponential growth of microorganisms and accumulation of product
residues. To minimize the risk of microbiological hazards cleaning procedures should be revalidated taking
the longest productions runs into account. If appropriate cleaning procedures should be adjusted to longer
production runs, e.g. by implementing intermediate cleaning of product contact parts. Further it is
recommended to intensify product sampling for microbiological monitoring when starting prolongated
production. As longer production runs increase the risk of gradual formation of deposits on product handling
parts it is also recommended to intensify the monitoring of cleaning results. (See section 4.4.5)
4.4.10.2 Risks of changing between operating modes
Changing between non-aseptic and aseptic production mode increases the risk of microbiological hazards in
the aseptic mode due to widespread surface contamination when filling non-sterile product. Therefore,
switching between aseptic and non-aseptic production mode is not recommended.
However, if changing from non-aseptic to aseptic production mode is considered - using a risk-based
approach - cleaning and sterilization procedures, cleaning monitoring and microbiological monitoring of
product quality should be adjusted in order to restore microbiological safe conditions for filling commercially
sterile product after having filled commercially non-sterile product.
These considerations hold true when considering filling low and high acid products with Class V machines.

4.5 Change Management (Products and Packaging)
4.5.1 Change of Product Characteristics
Only product in line with the characteristics approved for commercial production should be filled. Changes in
product characteristics might have an impact on the performance of the filling machine. For hygienic filling
machines of hygiene classes IV and V a risk assessment according to the decision tree in Annex C is
recommended for following changes:
— New product
— Change in product recipe
4.5.2 Change of Packaging Characteristics
Only packaging approved for commercial production should be used in filling machines of hygiene classes IV
and V. Changes in packaging might have an impact on the decontamination performance of the filling
machine. For hygienic filling machines of hygiene classes IV and V a risk assessment according to the
decision tree in Annex B is recommended for following changes:
— New packaging design,
— Use of new packaging materials
— Modifications in the composition of packaging materials
— New supplier of packaging
5 Special Considerations
This section gives guidance for selecting the appropriate machine class and determines the machine class
according to design principles implemented. Furthermore, this section includes a summary of
decontamination requirements and an overview on microbiological tests used when qualifying hygienic filling
machines.
5.1 Selection of Hygiene Class
Fig. 1 gives guidance for the selection of the appropriate machine class for the intended use. Product
characteristics prior to filling are crucial for the determination of the hygiene class of filling machines. The
threshold-value of pH > 4,6 is set by FDA with respect to aseptic filling machines for food safety reasons. In
some products with a pH value in the range of 3.8 < pH ≤ 4.6 spore building product spoiling microorganisms
may grow. If these microorganisms are of relevance for the product to be filled, UHT-treatment of the product
and filling with class V machines will be necessary.

Fig.1: Decision tree for selection of appropriate Hygiene Class for filling machines
source: VDMA Doc. 2 (2016)
Explanations on decision tree for appropriate selection of VDMA Class of Hygiene Filling Machines
 Requirements concerning microbiological status of product prior to filling: Requirements for filling
microbiologically unstable products with filling machines of Hygiene Class IV or V intended for
distribution and storage at room temperature: Product free of viable microorganisms having public health
significance, as well as microorganisms of nonhealth significance capable of reproducing in the food
under normal nonrefrigerated conditions of storage and distribution (commercially sterile product).
 Requirements for ESL-products: pasteurized product, (to the most possible extend) free of
microorganisms capable of reproducing under refrigerated conditions in the cold chain.
Note: Reproduction of spoiling microorganisms is dependent on the permitted maximum temperature in
the cold chain. Therefore, the selection of the appropriate Hygiene Class is sensitive to the maximum
temperature applied for the specific cold chain under consideration.
 Requirements microbiologically unstable products intended for distribution and storage microbiologically
unstable products in cold chain: low germ load
 Criteria for characterizing the microbiological stability of products: aW-value, sugar concentration, salt
concentration, pH-value, …
 Examples for required intensified cleaning: Avoidance of cross-contamination (colouring, flavours, food
allergens, critical food-ingredients…)
 Product stabilization in the finished pack: E.g. by means of carbonisation, hot filling, addition of
preservatives, pasteurization after filling, autoclaving
5.2 Design Characteristics of Hygienic Filling Machines
The technical characteristics of hygienic filling machines for foods and beverages differ with respect to the
intended operation. In this EHEDG Guideline the VDMA classification scheme is adopted. This classification
scheme is implementing numbers ranging from I (lowest hygienic demands) to V (highest hygienic demands).
Classification is made with respect to the implementation of 12 design principles as shown in table 1.

Table 1: Classes of hygienic filling machines for liquid and semi liquid foods according to
VDMA Doc. 2 (2016)
Hygienic filling machine of hygiene class…
I (basic) II III IV V (aseptic)
1 Designed according to EN 1672-2 Yes Yes Yes Yes Yes
2 Cleaning of product contact surfaces Preferably CIP CIP CIP CIP
(internal parts of product line incl. CIP
dosing)
3 Cleaning of indirect product contact Manual Manual Preferably Preferably Preferably
surfaces (e.g. splash zone) automatic automatic automatic
cleaning cleaning; cleaning;
complementary complementary
manual cleaning if manual
appropriate cleaning if
appropriate
4 Cleaning of non-product surfaces (e.g. Manual Manual Manual Preferably Preferably
rest of machine, packaging automatic automatic
decontamination area) cleaning cleaning
5 Disinfection / sterilization of product Optional Disinfection using Disinfection using According to According to
contact surfaces (internal parts of heat or chemical heat or chemical VDMA Doc. 10 VDMA Doc. 11
product line incl. dosing) disinfectants disinfectants
Target: killing of Target: killing of
vegetative germs vegetative germs
6 Disinfection / sterilization of machine No No Optional target: According to According to
Design principles
cabinet (enclosed areas) killing vegetative VDMA Doc. 10 VDMA Doc. 11

germs
7 Disinfection of packing material No No Yes According to According to
VDMA Doc. 10 VDMA Doc. 11
8 Prevention of recontamination of product No No Optional Yes Yes
line (valve cluster to filler hopper till filling
nozzle) using aseptic barrier
9 Prevention of recontamination during No No Optional Yes Yes
packaging decontamination – transport –
filling – closing, air treatment
10 Automatic feedback control of No Monitoring Monitoring Monitoring Maximum
parameters substantial for hygienic requirements parameters parameters parameters technical
processing, e.g.: relevant to CIP relevant to CIP relevant to CIP safeguarding
− Temperature of saturized steam and sterilisation of according to
product route VDMA Doc. 11
− Sterile air consumption
Other parameters:
− H2O2 consumption
According to
− Temperature of sealing tools requirements of
− Temperature and concentration of applications and
CIP media specified by
− Valve positions machine user
11 Any ingress by operator into the sterile − − − No Yes
zone of the machine interior will trigger
to change machine status in “unsterile”
12 Protection against faulty operation by No No No According to user Maximum
means of control and feedback control requirement technical
systems specification safeguarding
Decontamination Requirements
Hygienic filling machines of class III, IV and V as a rule are equipped to decontaminate the product contact
surfaces, packaging and packaging aids as well as the machine interior. For filling machines of hygiene class
IV and class V minimum requirements with respect to different decontamination procedures and to
corresponding test microorganisms can be found in VDMA Doc. No. 10 for class IV machines and VDMA
Doc. No. 11 for class V machines. For class III machines usually no minimum requirements are stated with
respect to decontamination functionality.
For filling machines of, hygiene class III characteristic spoilage microorganisms should be named for the
products in the range of the intended use. Decontamination techniques proven to reliably kill the relevant
spoilage microorganisms should be selected for the technical specification.
Annex F includes minimum decontamination requirements for class IV and class V machines as stated in
VDMA documents No. 10 and 11.

5.3 Microbiological Qualification Tests Class IV and V
VDMA Document No 12 (2007) distinguishes four types of checks on the microbiological safety of hygienic
filling machines of hygiene classes IV and V:
1. Microbiological challenge tests for examining the sterilizing functions of the filling machine
2. Sterile test before start-up of commercial production
3. Microbiological assessment of a test production run
4. Tests conducted during production for purposes of quality assurance.
Table 2 summarizes the criteria for distinguishing the types of checks.

Table 2: Criteria for distinguishing categories of microbiological tests for qualifying hygienic filling
machines
Artificial contamination using
Machine ready for production
Production run destined for

Test of sterilising functions
Special production profile
commercial production
Machine cleared for
test microorganism
Start-up concluded
Test with original
Product
sale
1. Microbiological
yes yes no no ─ no ─ no
challenge test
if appro-
2. Sterile test no no yes yes no no no
priate
3. Microbio-
logical
assessment no no yes yes no yes yes no
of test produc-
tion run
4. Microbiological
tests accompany- no no yes yes no yes yes yes
ing production
5.3.1 Microbiological challenge tests
In these tests the effectiveness of the individual sterilizing functions of the filling machine are tested. They
cover packaging sterilization, sterilization of the sterile section in the interior of the machine, sterilization of
product-contact parts and, if necessary, the external sterilization of the packaging. A key feature of the tests
is that the packaging (including packaging aids) or the sections of the machine to be investigated are
inoculated with test microorganisms that are particularly resistant to the sterilization method employed. After
this the decontamination process in the filling machine is performed and the previously inoculated samples
are investigated in the laboratory. References for microbiological challenge tests are listed below.
— Code of practice - Testing the effectiveness of aseptic plants containing packaging sterilization
equipment, VDMA Documents, Food Processing Machinery and Packaging Machinery No. 6 (2nd ed.
2008)
— Code of practice - Testing aseptic plants: sterilization of the sterile zone of the machine interior, VDMA
Documents, Food Processing Machinery and Packaging Machinery No. 8 (2nd edition 2014)
— Code of practice - Testing hygienic filling machines of hygiene class V (aseptic filling machines): External
sterilization of packaging, VDMA Documents, Food Processing Machinery and Packaging Machinery No.
14 (2006).

For a detailed outline of aspects to be considered in relation with microbiological challenge tests see IFTPS
Document G.005.V1. Further VDI 4066 Part 3 provides additional information on the implementation of
microbiological challenge tests.
Because of the artificial inoculation these functional tests may be done before the machine is installed at the
user’s factory. Depending on the machine model these function tests may also be done in a sort of type test
by process authorities and the test results are presented to the machine user in the course of commissioning
of the machine.
5.3.2 Sterile test
During a sterility test, a representative number of packs are filled under production conditions. These packs
are tested microbiologically to reveal any systematic faults prior to start-up of commercial production.
Passing the sterile test is usually regarded as the prerequisite for start-up of commercial production.
This test is done on the production-ready machine and usually with the original product. Production-ready
implies that the filling machine has been cleaned and sterilized prior to the test. Furthermore, before carrying
out the test those operating parameters relevant to quality that are not automatically monitored by the
machine should be checked.
Preconditions for carrying out the sterile test are not only the successful conclusion of the microbiological
functional tests but also the proper installation of the machine and the successful test-run using a test
product suitable for the purpose. The sterile test is a test of the entire filling line and is also a check on the
suitability of the specified packaging material. Therefore, it is necessary to successfully complete the
functional tests on the upstream parts of the plant and to provide the specified packaging.
From its design the sterile test is based on the presumption that the machine is suitable for microbiologically
reliable filling and this has also been verified by the microbiological functional tests. The objective is to
establish with great certainty any systematic errors in the complex interplay of the product to be filled, the
packaging, operating staff and utility and sterilizing media and to eliminate these before start-up of
commercial production. For this reason, the sterile test should as far as possible be done under conditions
close to those in production and using the original product to be filled.
The result of a sterile test always relates to the product being filled at the time. Accordingly, when possible
the test should be carried out using the original product. If this is not possible a product should be used
which is comparable with the material to be filled with regard to its filling and microbiological properties.
If several products are to be filled on the same filling machine it has to be considered for which of these
products a separate sterile test should be done. Accordingly, it should be noted in the test documentation for
which products the filling installation has been given clearance for commercial production.
When there are changes to the filling machine, the product or processing conditions, it should be checked on
the basis of an analysis of the microbiological risks whether repetition of the sterile test is necessary. This
applies in particular to large rebuilding, repair and maintenance work on the entire filling line, the filling of
new products on the filling machine and changes in the properties of the packaging.
It is generally the case that the test can only identify those faults whose causative event occurs during the
test run. This should be taken into account in the ‘design’ of the sterile test. In practice, therefore, a specific
production profile representing typical sequences of operating states is frequently prescribed for the test run.
VDMA Doc. 12 (2006) gives an example of a sterile test.
As only faults can be identified whose causative event occurs during the test run. At best this may
accidentally be the case for unsystematic fault events showing no regular or reproducible pattern and rare
faults. Adjusting the production profile or enlarging the sample size does not produce any greater certainty in
this context. Accordingly, the possibility of the occurrence of unsystematic faults should also be taken into
consideration when outlining the quality assurance measures to accompany production (see section 5.4.4).
5.3.3 Microbiological assessment of a test production run
The microbiological assessment of test production runs is common especially in the drinks industry in the
course of commissioning high-performance filling plants. Usually a sterile test was done previously as
described in section 5.4.1, i.e. the plant on which the test is done is already producing for sale.

The methodical difference with respect to the sterile test lies, on the one hand, in a higher statistical
sensitivity because of higher sample size and, on the other hand, in simplified microbiological assessment. In
the production profile a normal production run is usually assumed. Special situations are not simulated. In
comparison with the sterile test the operating time is generally longer and the number of packs produced
higher.
If possible and sensible checks for swelling and product cloudiness are made for reason of simplified
microbiological assessment. When checking for yeasts and molds visual inspection is preferable.
Due to the nature of its set-up, a test production is not suitable for reliably detecting unsystematic faults.
Accordingly, the possibility of the occurrence of unsystematic faults should also be taken into consideration
when devising the quality assurance measures to accompany production (see section 5.4.4).
VDMA Doc. 12 (2006) gives an example of a microbiological assessment of a test production run.
5.3.4 Microbiological tests during production
It is recommended to introduce a risk-based sampling plan for filled and sealed packs to monitor the
microbiological performance of the filling line. Immediately after production start up the highest alert level
should be implemented to reinforce confidence in the microbiological reliability of the filling machine.
Annex E contains by way of example a risk-based sampling plan drawn from practice after a cup filling
machine was commissioned.
Annex D gives an example of an operation procedure to detect microbial contamination of packages

processed in filling machines of hygiene class IV and V.

6 References
EHEDG Guidelines
1) EHEDG Document No. 7: A method for the assessment of bacteria-tightness of food processing
equipment (2004)
2) EHEDG Doc. No. 34: Integration of hygienic and aseptic systems (2006)
3) EHEDG Doc. No. Doc. 44: Hygienic Design Principles for Food Factories (2014)
4) EHEDG Doc. No. 45: General principles of cleaning validation in the food industry (2015)
5) EHEDG Doc. No. 47: Guidelines on Air Handling Systems in the Food Industry - Air Quality Control for
Building Ventilation (2016)
Order information on EHEDG guidelines can be obtained under www.ehedg.org > Guidelines > Download &
Order Information (https://www.ehedg.org/guidelines/download-order-information).
Legislation
1) REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29

April 2004 on the hygiene of food stuffs
Standards
1) DIN 10514 (2009-05): Food hygiene - Hygiene training

2) DIN 10528 (2009-06): Food hygiene - Guideline for the selection of materials used in contact with
foodstuffs - General principles
3) DIN 8743 (2014-01): Packaging machines and packaging lines - Key figures to characterise operation
behaviour and requirements for data collection in an acceptance test
4) DIN 8784 (2013-09): Beverage filling lines - Minimum and order related specifications
5) ISO (ISO 11137-2:2013: Sterilization of health care products - Radiation - Part 2: Establishing the
sterilization dose
VDMA Documents on Hygienic and Aseptic Filling
1) Doc. 1: Two Methods for Determing Peroxide Residues in Empty Packaging at the Filling Machine – Test
Procedures, VDMA-Fachverbandsschriften Nahrungsmittelmaschinen und Verpackungsmaschinen Nr.
1; revised edition 2011
2) Doc. 2: Hygienic Filling Machines for Liquid and Viscous Foods - Classification and Typical Fields of
Application, VDMA-Fachverbandsschriften Nahrungsmittelmaschinen und Verpackungsmaschinen Nr. 2,
revised edition 2006
3) Doc 3: Checklist "Quality Assurance and Maintenance" for aseptic filling machines for the food industry
(English), Aseptic Production Lines: Unsterility Risks in Product and Feed Lines - Planning and
Installation Faults, VDMA-Fachverbandsschriften Nahrungsmittelmaschinen und
Verpackungsmaschinen Nr. 3; 2nd revised edition 2008
4) Doc. 4: Aseptic Production Lines: Unsterility Risks in Product and Feed Lines - Planning and Installation
Faults VDMA-Fachverbandsschriften Nahrungsmittelmaschinen und Verpackungsmaschinen Nr. 4; new
edition 2012
5) Doc. 5: Signal exchange for aseptic filling machines - Minimum requirements for safe operation
6) VDMA-Fachverbandsschriften Nahrungsmittelmaschinen und Verpackungsmaschinen Nr. 5, English
edition 2003
7) Doc. 6: Code of Practice - Filling Machines of VDMA Hygienic Class V: Testing the Effectiveness
Packaging Sterilization Devices, VDMA-Fachverbandsschriften Nahrungsmittelmaschinen und
Verpackungsmaschinen Nr. 6, 2nd revised edition 2008

8) Doc. 8: Code of Practice - Testing Aseptic Plants: Sterilizing the Sterile Zone in a Machine Interior,
VDMA-Fachverbandsschriften Nahrungsmittelmaschinen und Verpackungsmaschinen Nr. 8, 2nd revised
edition 2014
9) Doc. 10: Hygienic Filling Machines of VDMA Class IV for Liquid and Viscous Foods - Minimum
requirements and basic conditions for operation in accordance with specification VDMA-
Fachverbandsschriften Nahrungsmittelmaschinen und Verpackungsmaschinen Nr. 10, 2nd edition 2016
(forthcoming)
10) Doc 11: Aseptic Packaging Machines for the Food Industry - Minimum Requirements and Basic
Conditions for the Intended Operation, VDMA-Fachverbandsschriften Nahrungsmittelmaschinen und
Verpackungsmaschinen Nr. 11, 2nd edition 20165 (forthcoming)
11) Doc. 12: Guide to Checking the Microbiological Safety of Hygienic Filling Machines of VDMA Classes IV
and V, VDMA-Fachverbandsschriften Nahrungsmittelmaschinen und Verpackungsmaschinen Nr. 12,
English edition 2008
12) Doc. 14: Code of Practice - Testing Hygienic Filling Machines of VDMA Class V External Sterilization of
Packaging Materials VDMA-Fachverbandsschriften Nahrungsmittelmaschinen und
Verpackungsmaschinen Nr. 14, English edition 2007
13) Doc. 16: General Requirements on Packaging for Filling Machines of VDMA Hygiene Classes IV and V,
VDMA-Fachverbandsschriften Nahrungsmittelmaschinen und Verpackungsmaschinen Nr. 16, English
edition 2011
14) VDMA Riboflavin-Test: Information sheet Riboflavin test for low-germ or sterile process technologies:
Fluorescence test for examination of cleanability for food, aseptic, pharmacy and chemistry, Edition
December 2007
VDMA Documents are downloadable free of charge from http://www.vdma.org/publikationen
VDI 4066 Documents series
1) VDI 4066 Part 1: Hygienic requirements for the production and aseptically filling of beverage products -
Principles and design criteria 2013-05
2) VDI 4066 Part 2: Hygiene requirements for the production and aseptic filling of beverages and dairy
products - Hygiene training courses 2014-08
3) VDI 4066 Part 3: Hygiene requirements for the production and aseptic filling of beverages and dairy
products - Hints to microbiological performance tests 2014-08
4) VDI 4066 Part 4: Hygiene requirements for the production and filling of dairy products without
recontamination 2014-08
Other
1) ABMI 2010: Common Aseptic Validation Protocol

(downloadable from http://www.abm-industry.org/)
2) FDA PMO 2007: Grade "A" Pasteurized Milk Ordinance (2007 Revision) Appendix J
Standards:Fabrication of Single-Service Containers & Closures for Milk and Milk Products
3) Hennlich, W.: Guidelines for foodstuffs packaging – microbiological evaluation of non-absorbent
packaging materials and packages
In: Verpackungs-Rundschau 12/2004, P. 47-49
4) IDF Bulletin 300/1995 - Technical guide for the packaging of milk and milk products – Third edition 1995
5) IFTPS - Institute For Thermal Processing Specialists Document G.005.V1 GUIDELINES FOR
MICROBIOLOGICAL VALIDATION OF THE STERILIZATION OF ASEPTIC FILLING MACHINES
ANDPACKAGES, INCLUDING CONTAINERS AND CLOSURES, 2011
6) S. Krüger, R. Zschaler (2010): cleaning and disinfection – comment on DIN 10516, pp. 54 – 57, 2010,
Beuth publishing house - Extract on courtesy of the Beuth publishing house (downloadable from
www.vdma.org)

7) EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL (2012):
Guidance document on the implementation of certain provisions of Regulation (EC) No 852/2004 On the
hygiene of foodstuffs
8) EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY (2010)
Guide to application of the Machinery Directive 2006/42/EC, 2nd Edition, June 2010

Keywords for training programs with reference to hygienic filling plants
Examples for typical key words of a training program are listed below. Training should be conducted in both
theory and practice. (Source: VDMA Doc. No. 3 (2008)
Machine staff
Basic course for machine operators Continuation course for machine operators
• Instruction in safety • Instruction in safety

• Basic concepts of hygiene • Extended hygiene information
• Preparation and performance of sterilization • Extended packaging assessment
• Production • Basic concepts of hydraulics and pneumatics
• Cleaning including external cleaning • Fault identification and elimination in the
• Setting values and checking them mechanical field
• Daily/weekly maintenance • Preventive safeguarding of the machine
• Packaging inspection, dating hygiene standard
• Basic information about operating resources • Checking on operating resources
• Fundamentals of documentation
• Response to operating faults
Maintenance staff
Basic course "Maintenance I" Basic course "Maintenance II"
• Basic course in hygiene • Instruction in safety

• Instruction in safety • Control dimensions and special settings
• Setting values and dimensions • Inspections
• Maintenance work according to maintenance • Extended packaging assessment
instructions • Complex fault finding and elimination
• Preventive maintenance according to listings • Extended information about pneumatics and
• Fault-finding and repair in the mechanical field hydraulics
• Basic information about pneumatics and • Basic information about electrical engineering
hydraulics
QA (quality assurance) staff Management staff
Special course "Quality control" Special course for technical management
• Microbiology • Basic course in hygiene

• Checks on operating resources • Process workflows
• Weight checks • Production organization
• Statistics • Personnel deployment
• Laboratory checks • Quality assurance
• Return flow analysis • Warehousing and storage
• Troubleshooting in the event of unsterilities • Room layout
• Waste disposal
• Legal regulations

New Packaging Decision Tree
Decision tree for risk assessment of new packaging to be filled in filling machines of hygiene classes IV and
V. For alert production according to a risk-based sampling approach (see section 5.4.4)

New Product Decision Tree
Decision tree for risk assessment of new product to be filled in filling machines of hygiene classes IV and V.
For alert production according to a risk-based sampling approach (see section 5.4.4)

Unilever modified 3-drop-test3
Special Techniques – Examination of aseptically processed packs
1. OBJECTIVE
To detect microbiological contamination in UHT-sterilized products.
2. INTRODUCTION
Microbiological contamination of UHT-sterilized and aseptically-packed products can be detected in several

ways. The "3-drops technique" is considered more reliable than other conventional techniques. The detection
limit of the "3-drops technique" is about 20 microorganisms per ml of sample. This presumes that one drop is
about 0.05 ml product and contains at least one microorganism. Generally microbial contamination during the
production of UHT-sterilized analyzed directly after production. To detect lower levels of contamination packs
are incubated for at least 5 days at 30 °C to enable any microorganisms present to multiply to a detectable
level.
3. PRINCIPLE
Traditionally for the "3-drops technique" 3 drops of a pre-incubated sample are inoculated onto each of two
Petri dishes containing Plate Count Agar (PCA) and Trypticase Soy Agar + cysteine (TSAC). PCA is
incubated aerobically and TSAC anaerobically incubated for 3 days at 30 °C. The method is modified by
addition of 0.005 % 2,3,5 -Triphenyl -Tetrazolium Chloride (TTC) to both media. The colourless TTC is
reduced during the incubation time by microorganisms to the red formazan which results in pink to red-
coloured sample drops and microbial colonies. The sample is considered to be contaminated only when all
the three drops of one or both agars demonstrate growth of microorganisms.
4. MEDIA
Plate Count Agar + TTC - PCA+TCC - (M83, see 9).
Trypticase Soy Agar + Cysteine + TTC - TSAC+TCC - (M84, see 10).
5. SUNDRIES
— Cotton wool.
— 70 % (w/w) ethanol.
— A scalpel holder with disposable scalpel knives sterile and individually wrapped e.g. Sterile Scalpelklinge
Bahya Tuttlingen Germany, or disposable Swan-Morton scalpels (UK supplier).
— Sterile disposable inoculation loops supplying about 0.05 ml sample.
6. PROCEDURE
a) Incubate the samples for 5 or 10 days at 30 °C according to practice.
b) Decontaminate the upper side of the pack by swabbing the surface with cotton wool drenched in 70 %
ethanol and open the pack with either a sterile scalpel or one flamed in absolute alcohol.
c) Pipette 5 ml if liquid or if viscous, aseptically weigh 5 g into a sterile capped 20 ml test tube.
d) Put with a pipette from the test tube, or if the sample is too viscous with an inoculation loop, three drops
on the surface of a PCA+TCC plate and a TSAC+TCC plate as shown on the photograph
3 Reprinted by kind permission of Unilever

(appendix 1) and incubate the PCA+TCC plate aerobically and the TSAC+TCC plate anaerobically (see
UMAmethod 0350) at 30 °C for 3 days
e) Store the remaining sample in the test tube at 5 °C.
f) Check the performance of the three drops technique at regular intervals with artificially contaminated
samples.
7. EVALUATION
Check if the sample drops on the plates are coloured pink to red and eventually show pink to red- coloured
colonies. The sample has considered to be contaminated only if the sample drops are coloured pink to red or
if pink to red -coloured microbial colonies are formed on all the three spots. If colony growth occurred on two
or one spot only this can be due to an artefact (e.g. a small microbial contamination during the handling of the
test). The test has to be repeated, in that case, with the sample stored at 5 °C.
8. ISOLATION OF MICROORGANISMS
Isolate and identify the microorganism(s) from samples found to be contaminated, this to collect valuable
data making it possible to identify the origin of the problem.
9. MEDIUM M83 - PLATE COUNT AGAR + 2,3,5-TETRAPHENYL-TETRAZOLIUM CHLORIDE

(PCA+TCC)
Description
One of two non-selective media containing TCC to aid colony recognition, for use in the examination of
aseptically-processed packs.
Commercial alternatives: Oxoid CM 325, Merck 5463, Difco 0479, BBL 11638 (Standards Method agar), to
which 2, 3, 5-typhenol-tetrazolium chloride solution is added at the time of preparing plates for surface
inoculation.
Ingredients Plate Count Agar:
— Tryptone 5.0 g
— Yeast extract 2.5 g
— Glucose 1.0 g
— Agar 15.0 g
Preparation
a) Heat to dissolve the ingredients in 1 litre deionised water by boiling.
b) Adjust the pH so that after autoclaving it is 7.0 ± 0.2 at 25 °C.
Adjust the pH of commercial media only if prescribed by the supplier.
c) Dispense into 100-ml amounts.
d) Autoclave at 121 °C for 15 min.

Supplement - 2, 3, 5-Triphenol-tetrazolium chloride solution
Commercial alternative: Oxoid SR148.
2,3,5-Triphenol-tetrazolium chloride 0.05 g

Deionised water 100 ml
Dissolve the TTC in the water and sterilize by membrane filtration.
Store at 4 °C and discard if not used within 3 months or a precipitate forms.
Preparation of final medium
a) Melt the agar and cool to 48 ± 1°C.
b) To each 100 ml of agar add 10 ml of TTC solution.
c) Mix well and pour 12-15 ml into Petri dishes.
d) Dry the plates before inoculation.
10. MEDIUM M84 - TRYPTONE SOYA AGAR + L-CYSTEINE AND 2,3,5- TRIPHENYLTETRAZOLIUM
CHLORIDE (TSCA+TCC)
Description
One of two non-selective media containing TCC to aid colony recognition, for use in the examination of
aseptically-processed packs.
Commercial alternatives: The following TSA media can be used, but need the addition of Lcysteine to the
base medium and TCC solution when preparing dishes. Oxoid CM 131, Difco 0369, Merck 5458, BBL 11043.
Ingredients
— Tryptone 15.0 g
— Soya peptone 5.0g
— Sodium chloride 5.0g
— Yeast extract 6.0g
— L-cysteine 0.03g
— Agar 15g
Preparation
a) Heat to dissolve the ingredients in 1 litre deionised water by boiling.
b) Adjust the pH so that after autoclaving it is 7.0 ± 0.2 at 25 °C.
Adjust the pH of commercial media only if prescribed by the supplier.
c) Dispense into 100-ml amounts.
d) Autoclave at 121 °C for 15 min.
Supplement - 2, 3, 5-Triphenol-tetrazolium chloride solution
Commercial alternative: Oxoid SR148.

2, 3, 5-Triphenol-tetrazolium chloride 0.05 g
Deionised water 100 ml
Dissolve the TTC in the water and sterilize by membrane filtration.
Store at 4 °C and discard if not used within 3 months or a precipitate forms.
Preparation of final medium
a) Melt the agar and cool to 48 ± 1 °C.
b) To each 100 ml of agar add 10 ml of TTC solution.
c) Mix well and pour 12-15 ml into Petri dishes.
Appendix 1
3-Trop-Test
Situation 1 Situation 2 Situation 3
A sample is only considered as contaminated, if colonies are formed on all the 3 spots (situation 3).

Risk based sampling plan

Minimum decontamination requirements for filling machines of VDMA
hygiene classes IV and V
Compilation of minimum requirements for decontamination performance of hygienic filling

machines of VDMA classes IV and V
The requirements listed below are a summary of minimum requirements stated in VDMA Doc. No. 10 (2nd ed.
2015) and VDMA Doc. No. 11 (3nd ed. 2015). This compilation does not claim to be comprehensive. For
technical decontamination procedures not mentioned minimum decontamination requirements should be
specified which correspond to the microbiological safety level of the technical procedures stated.
If hygienic filling machines of class IV are meant to reliably kill specific spoiling microorganisms it is
recommended to match the decontamination procedure with the group of microorganisms considered.
If for hygienic filling machines of class IV is agreed upon that in deviation to the test microorganism stated in
this compilation Aspergillus spores as a surrogate of spoiling microorganisms should be used as test
organism the following minimum requirements are recommended for decontamination procedures using
hydrogen peroxide, peracetic acid, saturated steam or pressurized hot water:
— Decontamination of packaging and sterile zone of machine cabinet: at least count reduction of 4 log
cycles for Asp. brasiliensis (DSM 1988/ATCC 16404)
— Decontamination of product conveying systems: at least count reduction of 5 log cycles for Asp.
brasiliensis (DSM 1988/ATCC 16404).
Decontamination of packaging (surfaces in contact with product):
Decontamination Class IV Class V

procedure Test microorganisms, required minimum Test microorganisms, required minimum
count reduction count reduction
H2O2 Spores of Bacillus atrophaeus (ATCC 9372, DSM Spores of Bacillus atrophaeus (ATCC 9372, DSM
675, former Bacillus subtilis variety niger) or Bacillus 675, former Bacillus subtilis variety niger) or Bacillus
subtilis SA 22 (identical to NCA 72-52 and to DSM subtilis SA 22 (identical to NCA 72-52 and to DSM
4181) 4181)
Count reduction ≥ Log 3 Count reduction ≥ Log 4
saturated steam Spores of Geobacillus stearothermophilus NCA Spores of Geobacillus stearothermophilus NCA
and pressurized hot 1518, ATCC 7953 (identical to DSM 5934) 1518, ATCC 7953 (identical to DSM 5934)
water Count reduction ≥ Log 3 Count reduction ≥ Log 4
peracetic acid Spores of Bacillus atrophaeus (ATCC 9372, DSM Spores of Bacillus atrophaeus (ATCC 9372, DSM
based products 675, former Bacillus subtilis variety niger) or Bacillus 675, former Bacillus subtilis variety niger) or Bacillus
subtilis SA 22 (identical to NCA 72-52 and to DSM subtilis SA 22 (identical to NCA 72-52 and to DSM
4181) 4181)
e-beam Note: decontamination method was introduced Note: decontamination method was introduced
shortly before publication of this document. VDMA shortly before publication of this document. VDMA
hasn't published minimum requirements then. hasn't published minimum requirements then.
Reference may be made to ISO 11137-2:2013 for Reference may be made to ISO 11137-2:2013 for
determination of sterilization dose needed. determination of sterilization dose needed.
UVC Asp. brasiliensis DSM 1988/ATCC 16404 Count -

reduction ≥ Log 3
Infrared light and Asp. brasiliensis DSM 1988/ATCC 16404 -

dry heat Count reduction ≥ Log 3
Pulsed Light Asp. brasiliensis DSM 1988/ATCC 16404 -

Count reduction ≥ Log 3

H2O2 + UV Spores of Bacillus atrophaeus (ATCC 9372, DSM -
675, former Bacillus subtilis variety niger) or Bacillus
subtilis SA 22 (identical to NCA 72-52 and to DSM
4181)
or
Asp. brasiliensis DSM 1988/ATCC 16404)
Decontamination of sterile zone of machine cabinet:

procedure Test microorganisms, required Test microorganisms, required
minimum count reduction minimum count reduction
H2O2 Spores of Bacillus atrophaeus (ATCC 9372, Spores of Bacillus atrophaeus (ATCC 9372,
DSM 675, former Bacillus subtilis variety niger) DSM 675, former Bacillus subtilis variety niger)
or Bacillus subtilis SA 22 (identical to NCA 72- or Bacillus subtilis SA 22 (identical to NCA 72-
52 and to DSM 4181) 52 and to DSM 4181)
saturated steam Spores of Geobacillus stearothermophilus NCA Spores of Geobacillus stearothermophilus

1518, ATCC 7953 (identical to DSM 5934) NCA 1518, ATCC 7953 (identical to DSM
Count reduction ≥ Log 3 5934)
peracetic acid Spores of Bacillus atrophaeus (ATCC 9372, Spores of Bacillus atrophaeus (ATCC 9372,
based products DSM 675, former Bacillus subtilis variety niger) DSM 675, former Bacillus subtilis variety niger)
or Bacillus subtilis SA 22 (identical to NCA 72- or Bacillus subtilis SA 22 (identical to NCA 72-
52 and to DSM 4181) 52 and to DSM 4181)
Dry heat Asp.brasiliensis DSM 1988/ATCC 16404 -

Decontamination of product conveying systems
In case sterilization is required:
Temperature/time-combination for sterilization by saturated steam and pressurized hot water:
121°C; 20 min. for product conveying parts of the filler (or equivalent conditions), to be verified at the coldest spot
For other decontamination procedures and verification using test microorganisms:

procedure Test microorganisms, required Test microorganisms, required
minimum count reduction minimum count reduction
H2O2 Spores of Bacillus atrophaeus (ATCC 9372, Spores of Bacillus atrophaeus (ATCC 9372,
DSM 675, former Bacillus subtilis variety niger) DSM 675, former Bacillus subtilis variety niger)
or Bacillus subtilis SA 22 (identical to NCA 72-52 or Bacillus subtilis SA 22 (identical to NCA 72-
and to DSM 4181) 52 and to DSM 4181)
saturated steam Spores of Geobacillus stearothermophilus NCA Spores of Geobacillus stearothermophilus NCA
and pressurized hot 1518, ATCC 7953 (identical to DSM 5934) 1518, ATCC 7953 (identical to DSM 5934)
water Count reduction ≥ Log 4 Count reduction ≥ Log 5
peracetic acid Spores of Bacillus atrophaeus (ATCC 9372, Spores of Bacillus atrophaeus (ATCC 9372,
based products DSM 675, former Bacillus subtilis variety niger) DSM 675, former Bacillus subtilis variety niger
or Bacillus subtilis SA 22 (identical to NCA 72-52 variety niger) or Bacillus subtilis SA 22
and to DSM 4181) (identical to NCA 72-52 and to DSM 4181)

Global Ehedg46

Uploaded by

Copyright:

Available Formats

Global Ehedg46

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Global Ehedg46

Uploaded by

Copyright:

Available Formats

DOC No.

Tel.: +49 69 66 03-12 17 or -14 30

DOC No. 46 ©EHEDG 2 of 40

DOC No. 46 ©EHEDG 3 of 40

Dr. Peter Golz** VDMA, Germany

Prof. Dr. Bernd Wilke Bosch Packaging Technology, Germany

Dr. Patrick Engelhard Krones, Germany

Rudolf Flörke SIG Combibloc, Germany

Cock Kranenburg Stork Food & Dairy Systems, Netherlands

Dr. Fritz Lembke Tetra Pak, Germany

Tineke Mostert Unilever, Netherlands

Admira Mesic Tetra Pak, Sweden

Dirk Nikoleiski Mondelez International, Germany

Dr. Viivi Nuottajärvi Lamican, Finland

Dr. Gunnar Rysstad Elopak, Norway

DOC No. 46 ©EHEDG 4 of 40

This document replaces EHEDG documents 3, 11 and 21.

1 Objectives and scope

DOC No. 46 ©EHEDG 5 of 40

2.1 Normative References

REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27

2.2 EHEDG Guidelines

EHEDG Doc. No. 8: Hygienic design principles

EHEDG Doc. No. 9: Welding stainless steel to meet hygienic requirements

Commercially sterile product for filling

Commercially sterile packaging and accessories

DOC No. 46 ©EHEDG 6 of 40

Hygienic filling machines of class V (aseptic filling machines)

Hygienic filling machines of class IV

Hygienic filling machines of class III

Hygienic filling machines of class II

Hygienic filling machines of class I

Microbiological challenge test

DOC No. 46 ©EHEDG 7 of 40

Sterile zone in the machine interior

4.1 Production Environment

4.1.2 Utilities, media supply and product supply

DOC No. 46 ©EHEDG 8 of 40

4.1.3 Installation of product and feedlines

4.1.4 Environmental Air Quality

DOC No. 46 ©EHEDG 9 of 40

4.1.6 Machine accessibility

4.1.7 Storage and handling of packaging material

4.2 Design Specification

4.2.1 Production environment

DOC No. 46 ©EHEDG 10 of 40

4.2.3 Packaging materials and packaging aids

1. Investigate sterilizability (for preformed containers and closures delivered non-sterile)

4.2.4 Hygienic design requirements

DOC No. 46 ©EHEDG 11 of 40

4.2.6.1 Machine Decontamination

4.2.6.2 Packaging Decontamination

DOC No. 46 ©EHEDG 12 of 40

4.2.7 Signal exchange between individual subsystems of a hygienic plant

4.3 Qualification Sequence of Hygienic Filling Machines

Document revision management should be applied following approval of technical documentation.

Measures may include but are not restricted to:

4.3.3 Phase 3: Checking correct installation in accordance with specification (corresponds to

DOC No. 46 ©EHEDG 13 of 40

— Checking connections to supply line