1. A Seminar
On…….
PRESENTED BY:-
Nimbalkar Pratik R.
M.Pharm. (Sem-I)
Quality Assurance Techniques
Roll.No.- 08
1

2. ENVIRONMENT
CONTROL
SYSTEM
HVAC
system
-Air filtration
-Pressurization
-Temperature
-Humidity
-Airborne
cleanliness
Architectural or
isolation
system
-Walls
-Flooring materials
-Door & window
-Glove box/isolator
-Door interlocking
device
Personnel
contamination
control
- Uniform
- Mask
- Gloves
Monitoring and
control system
Cleaning and
disinfection
system
-Material
-Method
-Equipment
2

3. PURPOSE
1)Provide a specific set of environment condition required for
the manufacturing process.
1) Heating and cooling
FUNCTIONS
USES
2) Humidifying and dehumidifying
3) Cleaning the air
4) Regulate air flow
5) Pressurization
1) To prevent contamination
2) To provide comfortable working conditions
3

4. Heating is significant in maintaining
adequate room temperature especially
during cold weather conditions.
Process of "changing" or replacing air in
any space to control temperature
or remove any combination
Air conditioning and refrigeration are
provided through the removal of heat
4

5. Objective
 Goal: To develop an automotive air-conditioning system that is
smaller and lighter than with conventional technology.
 The Challenge: The system must be capable of keeping a
temperature of 22˚C inside a room, with an outside
temperature of 40˚C. Also, the system must be an efficient
heating system, keeping an internal temperature of 15˚C with
an outside temperature of 0˚C.
5

6. H.V.A.C
 H.V.A.C – Heating, Ventilation and Air Conditioning system
 The HVAC regulates
 Room Temperature
 Humidity
 Air Quality
 Air Flow
6

7. H.V.A.C
COMPONENTS: Air conditioners
 AHUs
 Dehumidifiers/ Heater
 Filters (Pre & HEPA)
 Dust extractore
 Ducting (for delivery of controlled air)
 Supply fans
 Smoke detectores
 Damper
 Humidity/Temp./ Pressure sensor
 Heating & Cooling coils
7

8. DESIGN PARAMETERS
 Energy efficiency
 Cleanliness
 Cost
 Temperature uniformity
 Humidity control
 Chemical exhuast efficiency
 Noise control
8

9. Air handling unit
• Blower/Fan
• Heating and
cooling coils
• Humidifiers
• Dehumidifiers
Air distribution
Network
• Duct network
• Insulators
• Dampers or valves
Air filters
• Pre-filter
• Intermediates or
low efficiency
filter
• Terminal filter
(HEPA filter)
9

10. HVAC SPECIFICATIONS
Temperature
18-23 o C
Relative humidity
45% 5%
Dry powder = 30% 5%
Moisture sensitive drug = 5%
Air velocity
80- 120 ft/min
Air flow
Laminar airflow
Pressure gradient
15 Pascal
Particulate count (Critical area)
5%
NMT 100 particles
Air system failure alarm (ASFA)
10

11. A Particulate monitoring in air
Monthly
Daily
B HEPA filter integrity testing
Yearly
C Air change rate
Monthly
D Temperature and Humidity
Daily
E Air pressure differentials
Daily
F Microbiological monitoring
Daily ( In aseptic areas)
Decreased frequency in other
areas
11

12. 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
12

13. B. Internal Sources Control is primarily through airflow design.
 Construction finishes; personnel and garments; materials and equipments.
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 .
13

14. AIR FLOW PATTERNS
Workbench (vertical)
Cabin/ booth
Ceiling
14

15. Air conditioners
An air conditioner designed to change the
air temperature and humidity within an area (used for cooling and
sometimes heating depending on the air properties at a given time).
The cooling is typically done using a simple refrigeration cycle, but
sometimes evaporation is used,
15

16. AHUs
• The air handling unit is an equipment consisting of
fans, heating and cooling coils, air-control dampers, filters .
• It collect and mix 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
16

17. Dehumidifiers/ Heater
•In dehumidifier evaporator and condenser coils are placed in the
same air path, and the entire unit is placed in the environment .
• Having the condenser coil in the same air path as the evaporator
coil produces warm, dehumidified air
•The air next passes over the condenser coil, re-warming the now
dehumidified air.
17

18. Filters
•A particulate air filter is a device composed of fibrous materials
which removes solid particulates such as dust, pollen grains, mold, 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.
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19. Dust extractore
•A dust collection system is an air
quality improvement system
•Dust collection systems work on
the basic formula of capture,
convey and collect.
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20. Ducting (for delivery of controlled air)
•Ducts are used to deliver and remove air.
•A duct system is often called as
ductwork.
Materials
1. Polyurethane and Phenolic insulation
panels (pre-insulated air ducts)
1. Fiberglass duct board (preinsulated
nonmetallic ductwork
1. Flexible Ducting
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21. Supply fans
• Flow rate controlled by inlet vanes or outlet
dampers on the fan.
• The supply fan speed is controlled to maintain pressure in the supply
duct.
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22. Smoke detectars
• A smoke detector is a device that detects smoke, typically as
an indicator of fire. Commercial, industrial, and mass
residential devices issue a signal to a fire alarm system
22

23. Damper
• A plate or gate placed in a duct to control air flow
by increasing friction in the duct.
• Smoke damper
A damper or adjustable louver designed to
augment the ventilation of a space during a fire.
23

24. 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.
24

25. Heating & Cooling coils
A heating coil is a piece of equipment built
for efficient heat transfer from one medium to
another
A cooling coil cools air blown
across it and into the building
occupied space.
25

26. What can HVAC do?
 Control airborne particles, dust and micro-organisms
 Maintain room pressure (delta P)
 Maintain space moisture (Relative Humidity)
 Maintain space temperature
26

27. What HVAC can’t do?
 1. HVAC can not clean up the surfaces of a contaminated
places, room or equipment
 2. HVAC can not compensate for workers who do not follow
procedures
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28. Animated representation of working of AHU/HVAC
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29. ROOM PRESSURIZATION
• The clean room is positively pressurized with respect to the
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 and prevention of flow reversal, but should not
be so high as to create turbulence problems.
•Example :-Cascade airlock: high pressure on one side of the
airlock and low pressure on the other.
29

30. TYPES OF CLEAN ROOMS

Horizontal Clean Room – Horizontal Laminar flow
(HEPA filters in a wall force clean air from one side of the room to
other.)

Vertical Clean Room – Vertical Laminar flow
(HEPA filters on the ceiling push clean air down to the floor.)
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31. FOUR BASIC PRINCIPLES OF CLEAN ROOM

Not To Bring Any Dust

Not To Accumulate Any Dust

Not To Generate Any Dust

To Remove Any Dust Quickly
31

32. Validation of AHU/HVAC System

Temperature control test

Humidity control test

Filter integrity test

Air velocity test

Air flow pattern(Smoke test)

Microbial test
32

33. Objective:- To demonstrate the ability of the HVAC system
to control temperature.
Equipment- Thermometer
Test procedure:Environment is divided by a grid
Size of square- 60cm 60cm or more
Sampling location- work height
Result compare with specification
60 60
cm
Acceptance criteria:- Temp. 20 2ºC
33

34. Objective:- To demonstrate the ability of the HVAC
system to control humidity.
Equipment- Automatic humidity recorder
Test procedure:Environment is divided by a grid
Size of square- 60cm 60cm or more
Sampling location- work height
Result compare with specification
Acceptance criteria:- Humidity: 45 5%
60 60
cm
Fig.. Digital moisture
meter
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35. Filter Integrity Test:Objective:- To provide evidence of the integrity of the
HEPA filter
Acceptance criteria:99.97 efficiency- 0.03% particles of 0.3 µm
99.99 efficiency- 0.01% particles of 0.3 µm
100%
0.03%
HEPA filter
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36. DOP (Dioctyl phthalate) Test
HOT DOP
COLD DOP
• Efficiency test
• Integrity test
• Vaporization
• Pressurization
• Mono-disperse
aerosol
• Poly-disperse aerosol
• 0.3 µm
• > 0.3 µm
< 0.3 µm
0.3 µm (20-30 %)
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37. Air flow velocity and uniformity test:Test procedure:Environment is divided by grid
Measure by Airflow meter
Fig.- Airflow meter
Acceptance criteria:Vertical flows
0.30 m/sec
20%
Horizontal flows
0.45 m/sec
20%
Fig.- laminar air flow unit
Action: Deviation indicates blockage of filter
Solution : Alteration of fan speed
HEPA filter replacement
37

38. Test procedure:- (smoke test)
Generate visible smoke
upstream from the work zone
Establish the reference point
Videotape the direction of the
flow in both case
Determine the direction
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39. MICROBIOLOGICAL TESTS :Solid growth media
Sampling conditions
Sampling in the at rest condition may be continued at an agreed
frequency to monitor baseline contamination levels.
The operational conditions and the activities being performed at the
time of testing should be recorded.
Incubation conditions
Incubation of samples, inverted, at 20 – 25C for at least 5 days is
suitable for the growth of mould and fungi.
Incubation of samples, inverted, at 30 - 35C for at least 2 days is
suitable for the growth of bacteria.
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40. 1. Health-Care Facilities
Residences
2. Educational Facilities
3. Laboratories
4. Pharmaceutical
Industries
5. Non Pharmaceutical
Industries
6. Tall Buildings
7. Hotels
8. Places of Assembly
9. Nuclear Facilities
10. Commercial and Public
Buildings
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41. HVAU is
Heart
of Pharmaceutical Industries that purify
the outside air and circulate all over the areas.
HVAC system provide specific set of environment
condition which required to make quality product so
therefore it must be validated.
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42. References : www.cedengineering.com.
 www05.abb.com
 A. Bhatia, B.E. PDH Online | PDH Center,5272 Meadow





Estates Drive,Fairfax, VA 22030-6658.
www.who.int
www.pharmaguideline.com
en.wikipedia.org
www.pharmamanufacturing.com
www.cleanairtech.com.au
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