Ah HVAC System 04

،‫ﺑـﺴــــــــــﻢ اﻟﻠــــــﮫ‬
.‫ﺳ ْﺒ َﺤﺎﻧَﻚَ ﻻ ِﻋ ْﻠ َﻢ ﻟَﻨَﺎ ّإﻻ َﻣﺎ َﻋـﻠّـ ْﻤﺘَـﻨَﺎ إﻧّﻚَ أ ْﻧﺖَ اﻟ َﻌﻠِﯿ ُﻢ اﻟ َﺤ ِﻜﯿ ُﻢ‬
ُ
Introduction to HVAC
as a part of Clean Rooms System
Prepared & Presented By:-

Eng.\ Ahmed ElSobhy M. Omaira
Maintenance Section Head.
JEDCO International Pharmaceuticals.
1
Heating, Ventilation and Air Conditioning system
Process of "changing" or replacing air in

any space to control temperature,
Humidity or Both.
Also Control of Smell.
Air conditioning is a process of adding or

removing either Heat or Humidity.
2
1) Provide a specific set of environmental conditions
required for the Manufacturing Process.
PURPOSE
2) To provide Comfortable Working Conditions.
3) To Prevent Contamination.
1) Heating and cooling.

2) Humidifying and dehumidifying.
FUNCTIONS 3) Cleaning the air.
4) Regulate air flow.
5) Pressurization.
3
Why to Know about HVAC
HVAC Knowledge is ONE OF the main systems the
CLEAN ROOMS composed of.
Cleanroom is a controlled placement where products are
manufactured. And concentration of airborne particles is controlled to
specified limits. So we need to Control Process of killing ultra-fines
airborne contaminants. The contaminations are generated by people,
processes, facilities, and equipment. They must be continually removed
from the air. The level of air cleanliness in the room must be regulated by
standards.
 Contaminant is a foreign mater which negatively affects the process or Product.

4
Clean Room Monitoring and
control system
System
HVAC Architectural Personnel Cleaning

system or isolation contamination and
system control disinfection
system
-Air filtration - Uniform

-Walls -Material
-Pressurization - Mask
-Flooring materials -Method
- Gloves
-Temperature -Door & window -Equipment
- Special
-Humidity -Glove box/isolator Gowning
-Airborne -Door interlocking - Behavior
cleanliness device.
- Drainage.
5
• Heating & Cooling Equipment [Chillers, Cooling towers and Boilers].
• AHUs – Air Handling Units.
• Heat Exchangers.
• Filters (Pre & HEPA).
• Fans and Blowers.
• Humidifiers / Dehumidifiers.
• Ducting (for delivery of controlled air).
• Humidity/Temp./ Pressure sensor.
• Process/Parameters Control System.
6
7
Heating and Cooling Equipment.
Chillers.
Water cooling
equipment.
8
Heating and Cooling Equipment. Boilers.
Water Heating
equipment.
9
Air Handling Units
• The air handling unit is an equipment consisting of
fans, heating and cooling coils, air-control dampers,
filters .
• It collects and mixes outdoor air with that
returning from the building space.
• The air mixture is then cooled or heated, after
which it is discharged into the building space
through a duct.
10
Air Handling Units
11
Air Handling Units
12
Air Handling Units
13
Heat Exchangers.
Heat Exchanger is a
piece of equipment built
for efficient heat
transfer from one
medium to another. For
cooling you may pass
chilled water to cool Air,
while for Heating you
may pass Hot water to
warm Air.
14
Filters.
•A particulate air filter is composed of fibrous materials which
removes solid particulates such as dust, liquid droplets and bacteria
from the air.
• A chemical air filter consists of an absorbent or catalyst for the
removal of airborne molecular contaminants such as volatile organic
compounds or ozone.
•Air filters are used in applications where air quality is important.
15
Filters.
Pre-filter
16
Filters.
Bag-filter
17
Filters.
HEPA-filter
18
Fans and Blowers.
The HEART
which pumps
air through
Duct system
to specified
Areas.
19
Fans and Blowers.
20
21
Dehumidifiers
22
Ducting and Air distribution.
They are pipes of certain shape and size to distribute Air in the
HVAC system as Supply, Return or Exhaust Air.
23
24
25
Humidity/Temp./ Pressure sensors.
• This function board is used to
measure humidity.
• Temperature sensors are devices used to

measure the temperature.
A pressure sensor measures pressure,

typically of gases or liquids.
26
Temperature 18 - 25 o C
40% ± 10%
Relative humidity Dry powder = 30% ± 5%
Moisture sensitive drug = 10% ± 5%
Air velocity 80 - 120 ft/min = 0.41 – 0.61 m/s
Air flow Laminar airflow
Pressure gradient 15 Pascal
Particulate count (Critical area) Define ISO Class.
Air system failure alarm (ASFA)
27
Particulate monitoring in air Monthly
Daily
HEPA filter integrity testing Yearly
Air change rate Monthly
Temperature and Humidity Daily
Air pressure differentials Daily
Microbiological monitoring Daily ( In aseptic areas)
Decreased frequency in other
areas
28
Three Basic Principles Of Clean Room HVAC
To Remove Any Dust Quickly
Not To Accumulate Any Dust
Not To Bring / Generate Any Dust
29
Sources of contamination
A. External Sources:-
The external contamination is controlled primarily by
1. High efficiency filtration,
2. Space pressurization and
3. Sealing of space penetrations
30
B. Internal Sources:-
Control is primarily through airflow design.
Construction finishes; personnel and garments; materials and

equipment.
31
Important control precautions include:-
1. Walls, floors, ceiling tiles, doors, and windows.
2. People must wear garments.
3. Materials and equipment must be cleaned before entering the clean room.
4. Room entrances such as air locks .
5. Air showers are used to remove contaminants from personnel before

entering .
32
33
34
35
What HVAC can do?
 Control airborne particles, dust and micro-organisms.
 Maintain room pressure (Δ P – delta P).
 Maintain space moisture (Relative Humidity – Absolute Humidity).
 Maintain space temperature.
36
What HVAC can’t do?
 HVAC can not clean up the surfaces of a contaminated places, room
or equipment.
 HVAC can not compensate for workers who do not follow

procedures.
37
Room Pressurization
• The clean room is positively pressurized with respect to the less

clean adjacent areas.
• This is done by supplying more air and extracting less air from
the room than is supplied to it
•The pressure differential should be of sufficient magnitude to

ensure containment prevention and avoid of flow reversal, but
should not be so high as to create turbulence problems.
38
Validation of AHU/HVAC System
 Air Flow Velocity And Change  Filter Integrity Test ( DOP/PAO
Per Hour. Test).
 Filter Leak Test.  Particles Count.
 Air flow pattern(Smoke test)  Viable Monitoring.
 Recovery (Temperature &

 Pressure Difference.
Humidity).
 Temperature and Humidity

 Fresh Air Determination
Uniformity Test.
39
HVAC is the Heart of Pharmaceutical Industries that
purify the outside air and start a Clean Room .

HVAC system provide specific set of environment
conditions which required to make quality product so
therefore it must be Validated .
40
References :-
www.who.int
www.pharmaguideline.com
www.pharmamanufacturing.com
www.cleanairtech.com.au
.‫ ﻧﺸﮭﺪ أن ﻻ إﻟﮫ إﻻ أﻧﺖ‬،‫ﺳﺒﺤﺎﻧﻚ ﷲ وﺑﺤﻤﺪك‬

.‫ﻧﺴﺘﻐﻔﺮك وﻧﺘﻮب إﻟﯿﻚ‬ 41

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،‫ﺑـﺴــــــــــﻢ اﻟﻠــــــﮫ‬

Prepared & Presented By:-

Process of "changing" or replacing air in

Air conditioning is a process of adding or

1) Heating and cooling.

 Contaminant is a foreign mater which negatively affects the process or Product.

HVAC Architectural Personnel Cleaning

-Air filtration - Uniform

• Temperature sensors are devices used to

A pressure sensor measures pressure,

Air system failure alarm (ASFA)

To Remove Any Dust Quickly

Not To Accumulate Any Dust

Not To Bring / Generate Any Dust

1. High efficiency filtration,

2. Space pressurization and

3. Sealing of space penetrations

Construction finishes; personnel and garments; materials and

2. People must wear garments.

4. Room entrances such as air locks .

5. Air showers are used to remove contaminants from personnel before

 Control airborne particles, dust and micro-organisms.

 Maintain room pressure (Δ P – delta P).

 Maintain space moisture (Relative Humidity – Absolute Humidity).

 Maintain space temperature.

 HVAC can not compensate for workers who do not follow

• The clean room is positively pressurized with respect to the less

•The pressure differential should be of sufficient magnitude to

 Filter Leak Test.  Particles Count.

 Air flow pattern(Smoke test)  Viable Monitoring.

 Recovery (Temperature &

 Temperature and Humidity

purify the outside air and start a Clean Room .

therefore it must be Validated .

.‫ ﻧﺸﮭﺪ أن ﻻ إﻟﮫ إﻻ أﻧﺖ‬،‫ﺳﺒﺤﺎﻧﻚ ﷲ وﺑﺤﻤﺪك‬

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