Heating, ventilation, and air conditioning is the technology of indoor and vehicular environmental comfort. Its goal is to provide thermal comfort and acceptable indoor air quality.

1. HVAC
System
(GMP Environment)
Present By-
Ranjit Pandey
Asst.QA Manager
Quality Assurance Department

3. HVAC overview
PURPOSE
Provide a specific set of environment
condition required for the manufacturing
process.
FUNCTIONS 1) Heating and cooling
2) Humidifying and dehumidifying FUNCTIONS
3) Cleaning the air
4) Regulate air flow
5) Pressurization
USES 1) To prevent contamination
2) To provide comfortable working
conditions
OBJECTIVE To develop an automotive air-conditioning system
that is smaller and lighter than with conventional
technology

4. The HVAC regulates
RoomTemperature
Humidity
Pressure Differential
Air Quality
Air Flow

6. AHU is a device used to regulate and circulate air as part of
a heating, ventilating, and air-conditioning
(HVAC) system.

8. GMPTraining

10. System of AHU

11. COMPONENTS:-
Air conditioners
AHUs
Dehumidifiers/ Heater
Filters (Pre & HEPA)
Dust extractor
Ducting (for delivery of controlled air)
Supply fans
Smoke detectors
Damper
Humidity/Temp./ Pressure sensor
Heating & Cooling coils

13. FILTER

14. Prefilter
AHU
1 2 3
Layout
GMPTraining

15. Pressure Differential
Differential pressure is the difference
in pressure between two separate points.
A differential pressure can be measured
between two points on independent systems or
between two different points on the same
system.
Pressure control devices should be linked to an
alarm system set according to the levels
determined by a risk analysis.
Airlocks can be important components in setting
up and maintaining pressure cascade systems
and also to limit cross-contamination

17. Pressure Cascade
Manufacturing
Room
Filling and Sealing
Room
Quarantine
Corridor
(Sterile Section)

18. Pressure Cascade
TABLETS
COMPR.
TABLETS
COMPR.
ENCAPSULATION
PRODUCTION CORRIDOR
AIR
LOCK
e.G Except Sterile

19. Air flow

20. Qualification of HVAC system

21. Qualification of HVAC
For a pharmaceutical facility, based on a risk assessment,
some of the typical HVAC system parameters that
should be qualified may include:
 Air Velocity Test & ACPH Calculations
 Air Pressure Difference Monitoring
 Integrity Test of HEPA Filters
 Non –Viable Air Borne Particle Count Test
 Recovery Test
 Temperature and Relative Humidity Test
 Air Flow Direction test and visualization
 Viable particle count Test
 Light Intensity Test
 Sound Level Test
 Containment Leak Test

22. 1. Air Velocity Test & ACPH
 Instrument used: Calibrated anemometer
 Air velocity from HEPA –v1, v2, v3, v4 & v5, 5 inch
distance from grill, hold time 10 sec.
 Calculation, CFM =A (area of grill)*V (avg. velocity)
 ACPH= Total CFM x 60/Total Room Volume(l*b*h)
 Acceptance Criteria , ACPH
 Class 100,000 =5 – 48 ISO Class 8 Non,pen,pen,cepha
 Class 10,000 =60-90 ISO Class 7 Sterile
 Class 1,000 =150-240 ISO Class 6
 Class 100 = 90 +/- 20% LAF ISO Class 5
Important Notes: Min.ACR for Class 100,000 rooms is 20
ACPH as per 2004 FDA Aseptic Guidelines.
D
C
A

24. 2. Air Pressure Difference Monitoring
 Instrument used : Magnehelic gauges
 Ensure that all doors are tightly closed and HVAC in
running condition.
 Ensure zero (0) set while the door is opened
 Record the differential pressure between rooms for every 1
hour for a period of 8 hours in each area.

25. 3. Integrity Test of HEPA Filters

26. 4. Non –Viable Air Borne Particle Count Test
 Instrument used :Particle counter
 Sampling point define as per room
size, air classification.
Usually at least 5 point

27. 5. RecoveryTest:
 Check actual particle count >generate smoke or
particle more 30 times of classified area
 AHU off :100 th >30*100 th
 AHU ON : Start reading by particle counter and
printout every 1 min until the maintain of class 100
th.
 Time taken to maintained design classified area i.e.
Recovery time.
 Acceptance Criteria: The clean room or clean
zone shall meet the acceptance criteria for
recovery time should not be more than 15 mins.

28. 6. Temperature and Relative Humidity Test
 Instrument used : Sling Psycho meter, Thermo meters
 This test should be performed at least 1 hour after the air
conditioning system has been operated and the conditions
have been stabilized.

29. HYGROMETRIC TABLE

30. 7. Air Flow Direction test and visualization:
 Instrument used: Video Camera

31. 8. Viable particle countTest
 Settle Plate Method:
 To determine the viable microbial contamination level in
clean rooms.
 Settle plates can detect bacteria and fungi that descend in the
column of air over the plate. Settle plates are the only
method that provides continuous monitoring of
microorganisms.
 In practice (MNC), the use of 3 to 5 days of incubation at 20
to 25oC followed by incubation 30 to 35oC for an additional
2-3 days has been shown to be sufficient to detect most
bacteria and fungi
 Procedure define SOP No.: QC/MIC/07 (Environment
Monitoring of different areas)