1. HVAC SYSTEM

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
Cleaning and disinfection system
-Material
-Method
-Equipment
Monitoring and control system

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

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

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.

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

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

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

9. Schematic Representation of HVAC system
Outside air
Distribution network
Exhaust
outlet
Heating coil Cooling coil
fan
humidifier
80% %
Intermediate filter
Mixing
chamber
Pre-filter
Valve / Dampers
Return air
Room
HEPA filter

10. COMPONENTS OF HVAC SYSTEM
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)

11. Air system failure alarm (ASFA)
HVAC SPECIFICATIONS
Temperature
18-23 o C
Relative humidity
45% ± 5%
Dry powder = 30% ± 5%
Moisture sensitive drug = 5% ± 5%
Air velocity
ft/min
Air flow
Laminar airflow
Pressure gradient
15 Pascal
Particulate count (Critical area)
NMT 100 particles of 0.5 µm/ft3
Air system failure alarm (ASFA)

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

13. 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

14. 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 .

15. Classification Of Clean Room
Class Limits "not to exceed" particles per cu ft for particle size shown
0.1μm
0.2μm
0.3μm
0.5μm
5 μm 1
35.0
7.50
3.0
1.0 -- 10
350
75.0
30.0
10.0
100
750
300
1000
7.0
10000
70.0
100000
700

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

17. 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,

18. 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

19. 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.

20. 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.

21. 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.

22. 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

23. 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.

24. 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

25. 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.

26. 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.

27. 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.

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

29. 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

30. Animated representation of working of AHU/HVAC

31. AIRFLOW DISTRIBUTION AND CONTROL
Unidirectional
Non-unidirectional airflow
Mixed patterns
Clean room
Class
Airflow Type
Av.Airflow Velocity,
fpm
Air changes/hr 1
Unidirectional
70-100 10
60-110
100
50-90
1000
Mixed
40-90
10000
25-40
60-120
100000
10-30
10-40

32. 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.

33. 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.)

34. 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

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

36. 1.Temperature control test:-
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
60×60cm
Acceptance criteria:- Temp. 20±2ºC

37. 2.Humidity control test:-
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
60×60cm
Acceptance criteria:- Humidity: 45±5%
Fig.. Digital moisture
meter

38. Filter Integrity Test:-
Objective:- To provide evidence of the integrity of the
HEPA filter
Acceptance criteria:-
99.97 efficiency % particles of 0.3 µm
99.99 efficiency % particles of 0.3 µm
100%
0.03%
HEPA filter

39. DOP (Dioctyl phthalate) Test
HOT DOP
Efficiency test
Vaporization
Mono-disperse aerosol
0.3 µm
COLD DOP
Integrity test
Pressurization
Poly-disperse aerosol
> 0.3 µm < 0.3 µm µm (20-30 %)

40. 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

41. Air flow system (Smoke test ) :-
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

42. 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 C for at least 2 days is suitable for the growth of bacteria.

43. APPLICATIONS OF HVAC Health-Care Facilities Residences
Educational Facilities
Laboratories
Pharmaceutical Industries
Non Pharmaceutical Industries
Tall Buildings
Hotels
Places of Assembly
Nuclear Facilities
Commercial and Public Buildings

44. WORKING OF HVAC SYSTEM

45. CONCLUSION
HVAU is 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.
Heart

46. References :- www.cedengineering.com. www05.abb.com
A. Bhatia, B.E. PDH Online | PDH Center,5272 Meadow Estates Drive,Fairfax, VA
en.wikipedia.org

47. Thanks