1. HVAC
Objective
To understand key issues in Qualification of HVAC systems )

2. HVAC
Qualification of the HVAC system is one component in the overall approach that covers premises, systems / utilities, equipment, processes, etc.

3. HVAC HVAC Applications… SYNTHETIC FIBRE PHARMACEUTICALS
HOSPITALS & MEDICAL RESEARCH CENTRE
THEATRE / AUDITORIUM / MULTIPLEX
EMBASSIES, AIRPORT,AIRLINES
NON MEDICAL RESEARCH CENTRE
OTHER INDUSTRIES & PROCESS PLANTS
OFFICES / HOTELS
BANKS…….

4. HVAC HVAC Qualification Flow Chart IMPLEMENTATION FAT & SAT
PQ Docs
All PQ tests
PQ Report
URS
What HVAC must do……Acceptance criteria
PERFORMANCE QUALIFICATION
Can we make the product?
OQ Docs
HEPA tests
Airflow
Air Changes
Recovery
DATA SHEET
(FRS)
How it is works…
OPERATIONAL QUALIFICATION
Do the systems work?
DESIGN QUALIFICATION
How to make or install...
INSTALLATION QUALIFICATION
Is it all there?
IQ Docs
Verify Installation
Calibration
Loop checks
Enhanced Design Review
IMPLEMENTATION
FAT & SAT
(Buy & Build)

5. Ramana Reddy.M ( CTO-3 QA)
HVAC
DESIGN QUALIFICATION
OBJECTIVE
SYSTEM DESCRIPTION
a. Air Circulation System - Supply Blower
Return Blower
b. Air Conditioning & Heating System - Cooling Coil
Heating Coil
c. Air Distribution System - Air Distribution Network
d. Air Filtration System - Fresh Air Filters
Secondary Filters
Return Air HEPA Filters
Terminal HEPA Filters
e. Dehumidification System - Dehumidifier
f. HFC System - HFC Unit (Hydroflurocarbons)
g. Control System - Instrumentation and Control System
h. Safety System - Safety precautions
3. BASIC DESIGN CONCEPT
4. ACCEPTANCE CRITERIA
METHODOLOGY
Summary and Conclusion
Design Qualification Approval
Ramana Reddy.M ( CTO-3 QA)

6. INSTALLATION QUALIFICATION
HVAC
INSTALLATION QUALIFICATION
The purpose of IQ is to verify and document the quality, installation and integrity of the HVAC system.
1. Pre-Approval
2. Overview
Purpose
Responsibility
Re-qualification
System Description
System Distribution
3. Equipment Specification
4. Equipment Identification
5. Equipment Location
6. Installation Qualification Procedure
Pre Requisite for IQ Test
Test Equipment
Qualification of Execution Team
Inspection Checklist
Installation Qualification
Major component Verification
Levelling and Alignment
Verification of Utilities
Verification of Installation
Check List for Duct Network
Drawings
Documents
SOP Verification
Deficiency (if any) and CAPA
7. Acceptance Criteria
8. Summary
9. Conclusion
10. Post-Approval

7. OPERATIONAL QUALIFICATION
HVAC
OPERATIONAL QUALIFICATION
The purpose of OQ is to establish, through documented testing, that all critical components are capable of operating within established limits and tolerances.
1. Pre-Approval
2. Overview
Purpose
Responsibility
Re-qualification
System Description
System Distribution
3. Operational Qualification Procedure
Pre Requisite for OQ Test
Test Equipments
Qualification of Execution Team
Inspection Checklist
Operational Qualification
Instrument Calibration
Key Functionality
Operational Checks
Safety Features
SOP verification
Deficiency / Corrective Action Report
4. Acceptance Criteria
5. Summary
6. Conclusion
7. Post-Approval

8. PERFORMANCE QUALIFICATION
HVAC
PERFORMANCE QUALIFICATION
The purpose of PQ is to verify and document that an HVAC system provides acceptable operational control under ‘ full operational ‘ conditions.
1. Pre-Approval
2. Overview
Purpose
Responsibility
Re-qualification
System Description
System Distribution
3. Performance Qualification Procedure
Validation Re-qualification Frequency
Validation Test Procedure
Qualification of Execution team
Test Instrument Calibration Record
3.1 Pressure Drop across the HEPA and Fine filters of Air Handling Unit
3.2 Air Velocity Measurement and Calculation of Air Changes
3.3 Integrity test of HEPA filters
3.4 Differential Pressure Test
3.5 Temperature and Relative Humidity Test
3.6 Air Flow Direction Test
3.7 Cleanliness Class Verification
(Non viable Particle Count)
3.8 Sound level Test
3.9 Light Level Test
3.10 Air Borne Viable Particle Monitoring
3.11 Recovery test

9. HVAC Re-qualification Scheduled Qualification
Scheduled qualifications as per validation plan shall be carried out.
Unscheduled Qualification shall be carried out incase of
Substitution of existing HVAC system with a new system.
Replacement of existing HEPA-Filter or critical component.
Any major modification to the existing HVAC system since purchase or after the last performance qualification.
Frequent surpassing of the alert or action limits of routine environmental monitoring parameters

10. Turbulent / mixed airflow Uni-directional airflow / LAF
HVAC
Examples of aspects to consider in qualification (OQ, PQ)
Test
Differential pressure on filters
Turbulent / mixed airflow
Description
Uni-directional airflow / LAF
Room differential pressure
Airflow velocity / uniformity
Airflow volume / rate
Parallelism
Airflow pattern 2
N/A
2, 3
Optional 3
1 := As built (ideally used to perform IQ)
2 = At rest (ideally used to perform OQ)
3 = Operational (ideally used to perform PQ)
Recovery time
Room classification (airborne particle)
Temperature, humidity
2,3

11. HVAC
3.1 Pressure Drop across the HEPA and Fine filters of Air Handling Unit
Objective:
The purpose of this test is to check the Clogged or clean condition of the across HEPA filters, Fine Filter and Pre - filter, of the Air Handling Unit.
Test Equipment:
Differential pressure Transmitter or Manometer
Procedure for HEPA, Fine and Pre Filters:
Ensure that the differential pressure transmitter is connected to before the filter and after the filter.
Check the status of the filter whether the filter is in clean condition or Clogged condition.
Acceptance Criteria:
HEPA, Pre and Fine filters should be in clean condition.
Manometer

12. HVAC 3.2 Air Velocity Measurement and Calculation of Air Changes
Objective:
To demonstrate that the air system is balanced and capable of delivering air velocities and providing number of air changes per hour in the respective rooms as per requirement.
Test Equipment:
Digital Anemometer / Vane Anemometer.
Procedure:
For compliance of air change rate, velocity to be measured at 5 different locations 2” below the each Terminal HEPA Filter or Grill (Four Corners and center) with the help of calibrated Anemometer.
Calculate the average velocity of the air coming from Supply Grill / Terminal Filter.
Calculate the airflow by multiplying the average velocity with the effective Grill area.
Air flow = Average Velocity x Face Area of the Air Inlet Grill / Filter
= Ft / Min. x Ft 2
= Ft 3 / Min. or CFM
Calculate the total airflow from all the Supply Grill / Terminal Filter in the room and add values to get the total airflow in the room (CFM).
Calculate the number of air changes per hour in the room by using the formula :
Air Changes / hour = Total air flow in the room (CFM) x 60
Room Volume ( Ft 3 )
Acceptance Criteria:
Average velocity and subsequent airflow through supply terminals should meet the design criteria of air change rate as per requirement.
Anemometer

13. Number of Air Changes / Hour
HVAC
3.2 Air Velocity Measurement and Calculation of Air Changes Cont…
CLASS
Number of Air Changes / Hour
CLASS 100
NLT 250
CLASS %
CLASS %

14. HVAC 3.3 Integrity (Leak) test of HEPA filters Aerosol Generator
Objective:
To check the installation integrity of the HEPA Filter in Air Handling Units.
Test Equipment:
Aerosol generator
Aerosol Photometer, duly calibrated with national / international traceability.
DOP Liquid (Di Octyl Phthalate) / PAO (Poly Alpha Olefin) Liquid
Procedure:
Position the Aerosol generator and introduce Aerosol into the upstream air, ahead of the HEPA filters, at the concentration of g per liter (this can be achieved with a compressed air pressure of 25 Psig) of air at the filter’s designed airflow rating and set the instrument at 100% concentration. Scan the downstream side of the filter with an appropriate photometer probe at a sampling rate of at least 1 ft3 / min. The probe should scan the entire filter face and frame at a position about 1 to 2 inches from the face of the filter. Scanning shall be done at the rate of maximum 2 feet per minute.
Acceptance Criteria:
During scanning percentage of the PAO/ DOP Liquid penetration shown by photometer should be less than 0.01% through the filter media and should be ‘zero’ through mounting joints for efficiency HEPA Filters and 0.001% for Efficiency.
Aerosol Generator
Aerosol Photometer

15. HVAC Filter Specifications 3.3 Integrity test of HEPA filters Cont….
Filter Grade
Efficiency
Filter Type
U 17
ULPA
U 16
U 15
99.999
H 14
99.99
HEPA
H 13
99.97
H 12
99.9
H 11 95

16. Differential Pressure Gauge
HVAC
3.4 Differential Pressure Test
Objective:
To demonstrate the capability of air system and to provide pressure gradient among different rooms.
Equipment Used:
Differential Pressure Display Unit or BMS System.
Procedure:
To avoid unexpected changes in air pressure and to establish a baseline, all doors in the facility must be closed and no man movement to be allowed during the observations. Observe the differential pressure through Display Unit or BMS System
Acceptance Criteria:
Pressure differentials should meet the requirement as specified in SYSTEM SPECIFICATION.
Differential Pressure Gauge

17. HVAC 3.5 Temperature and Relative Humidity Test Hygro meter Sensor
Objective:
To demonstrate the ability of the HVAC system to provide temperature and Relative Humidity within the specified range.
Test Equipment:
Temperature and Relative Humidity Sensor
Display Unit for Temperature and Relative Humidity
Procedure:
Observe the temperature and relative humidity through respective display unit wherever installed. Use Hygrometer to check the reading of Temperature and RH in other rooms.
Temperature and RH in the area to be checked and recorded in Static as well as Dynamic Condition.
Static Condition:
In static condition all the machines shall be kept switched ‘OFF’. Only restricted man movement shall take place.
Dynamic Condition:
In dynamic condition machines having maximum loads shall run and restricted man movement shall take place.
Acceptance Criteria
Temperature and relative humidity should meet the requirement as specified in system specification.
Hygro meter Sensor
Hygro meter

18. HVAC 3.6 Air Flow Direction Test Objective Procedure
To ensure that the HFC system in aseptic area, LAF and Pass box provide unidirectional airflow up to the working height during rest and operating condition.
To demonstrate that the air pressure is balanced and air is flowing from high-pressure zone to low pressure zone.
Procedure
Unidirectional Air Flow Area:
Static Condition in Unidirectional Air Flow Area:
Under HFC, no specific operation shall be carried out except Air Flow Pattern Test
Place a torch of Dry Ice / TiCl4 under HFC.
Observe the flow of Dry Ice / TiCl4 smoke at the filter downstream.
Videotape the smoke flow pattern.
Dynamic Condition in Unidirectional Air Flow Area:
During operation place a torch of Dry Ice / TiCl4 under HFC.
Non Unidirectional Air Flow Area:
Place the torch of Dry Ice / TiCl4 in between two rooms in door open condition.
Observe the flow of Dry Ice / TiCl4 smoke between the rooms.
Videotape / Photograph the smoke flow pattern.
Acceptance Criteria
Under HFC, Smoke Flow should be unidirectional up to working height
Smoke should flow from the higher-pressure zone to low-pressure zone between the rooms when the door is open.

19. Location of filter, doors, return air risers etc..
HVAC
Air Flow Direction
Location of filter, doors, return air risers etc..

20. HVAC AHU Air flow patterns Uni-directional Turbulent Prefilter
Main filter
Uni-directional
Turbulent 1 2 3

21. Air borne particulate counter
HVAC
3.7 Cleanliness Class Verification (Non viable Particle Count)
Objective:
To verify that the clean rooms are having cleanliness class as specified in specification sheet.
Test Equipment:
Air borne particulate counter of 1 CFM suction capacity, duly calibrated with traceability to national / international standard.
Procedure:
Particulate counting shall be carried out at predefined locations.
Particulate Count shall be taken in 3 rounds of Static condition and 3 rounds of Dynamic condition.
Static Condition:
In static condition all the machines shall be kept switched ‘OFF’. Only restricted man movement shall take place.
Dynamic Condition:
In dynamic condition the operator shall mock desired operation and restricted man movement shall take place.
Acceptance Criteria:
Clean room or clean zone shall meet the acceptance criteria for an air borne particulate as referred in standard ISO
Air borne particulate counter

22. HVAC
3.7 Cleanliness Class Verification (Non viable Particle Count) Cont….
ISO
ISO
> 0.1 m (Particles / Mt3)
> 0.2 m (Particles / Mt3)
> 0.3 m (Particles / Mt3)
> 0.5 m (Particles / Mt3)
> 1.0 m (Particles / Mt3)
> 5.0 m
(Particles / Mt3)
ISO 1 1 2
ISO 2
100 24 10 4
ISO 3
1 000
237
102 35 8
ISO 4
10 000
2 370
1 020
352 83
ISO 5
23 700
10 200
3 520
832 29
ISO 6
35 200
8 320
293
ISO 7 NA
83 200
2 930
ISO 8
29 300
ISO 9

23. HVAC
3.7 Cleanliness Class Verification (Non viable Particle Count) Cont….
FED STD 209 E CLASS
FED 209 E CLASS
> 0.1 m (Particles / Mt3)
> 0.2 m (Particles / Mt3)
> 0.3 m (Particles / Mt3)
> 0.5 m (Particles / Mt3)
> 5.0 m
(Particles / Mt3) 1 35
7.5 3 NA 10
350 75 30
100
750
300
1 000 7
10 000 70
700

24. Dynamic (in operation)
HVAC
3.7 Cleanliness Class Verification (Non viable Particle Count) Cont….
EU GGMP
EU GGMP
Static (at rest)
Dynamic (in operation)
> 0.5 m
(Particles / Mt3)
> 5.0 m
GRADE A
3 500 1
GRADE B
2 000
GRADE C
20 000
GRADE D
Not defined
GRADE E

25. > 0.5 m (Particles / Mt3)
HVAC
3.7 Cleanliness Class Verification (Non viable Particle Count) Cont….
FED STD 209 E / ISO / EU GGMP
CLASS
FED 209 E CLASS
ISO
EU GGMP
(in operation)
> 0.5 m (Particles / Mt3)
> 5.0 m
(Particles / Mt3)
Class 100 / ISO 5 / Grade A
100 NA
3 520 29
3 500 1
Class / ISO 7 / Grade C
10 000 70
2 930
20 000
Class / ISO 8 / Grade D
700
29 300
Not defined

26. HVAC 3.8 Sound level Test Objective: Test Equipment: Procedure:
To verify that the sound level is in limit in the clean room area.
Test Equipment:
Sound Level Meter, duly calibrated with traceability to national / international standard.
Procedure:
Take the reading at 5 locations in the room and take the average of the sound in the unit of decibels.
Acceptance Criteria:
The clean room or clean zone shall meet the acceptance criteria for sound level as mentioned below.
Sound Level Meter

27. HVAC 3.8 Sound level Test Cont…. S.No Cleanliness Class
Sound Level Limit
( db ) 1
Class 100 / ISO 5
NMT 60 2
Class 10, 000 / ISO 7
NMT 80 3
Class 1,00, 000 / ISO 8

28. HVAC 3.9 Light Level Test Objective: Test Equipment: Procedure:
To verify that the Light level is in limit in clean room area.
Test Equipment:
Lux Meter, duly calibrated with traceability to national / international standard.
Procedure:
Take the reading at 5 locations in the room and take the average of the light level in the unit of Lux.
Acceptance Criteria:
The clean room or clean zone shall meet the acceptance criteria for light level as mentioned below.
Lux Meter

29. Lighting Level Limit (lux)
HVAC
3.9 Light Level Test Cont….
S.No
Cleanliness Class
Lighting Level Limit (lux) 1
Class 100 / ISO 5
NLT 400 2
Class 10, 000 / ISO 7
NLT 300 3
Class 1,00, 000 / ISO 8

30. Air Borne Particle Counter
HVAC
3.10 Air Borne Viable Particle Monitoring
Objective:
To determine the air borne microbial contamination level in critical area.
Air borne microbial count by settling plate exposure method:
Pre incubated SCDA Media plates shall be exposed in Locations mentioned for 4 hours and incubated for 48 hours at 30°C to 35°C followed by next 72 hours at 20°C to 25°C.Record the results in respective format. PDA plates shall be exposed weekly to monitor the fungal counts. SCDA plates shall be incubated once in fifteen days to monitor the anaerobic Microorganisms
Air borne microbial count by Active Air Sampling:
To check the Viable Air borne particle count active air sampling is done and incubate the tested Cassettes for 48 hours at 30°C to 35°C and further for 72hours at 20°C to 25°C and observations are recorded in the respective format.
Acceptance Criteria:
All the Parameters performed in the area should meet the following requirements.
Petri Dish
Air Borne Particle Counter

31. HVAC 3.10 Air Borne Viable Particle Monitoring Cont… Locations
Microbial Count
Plate Exposure
[CFU/plate]
Air Sampling
[CFU/ 1 m3]
Alert
Action
Class 100
---
<1
-----
Class 10000 3 5
Class 20 30

32. Air borne particulate counter
HVAC
3.11 Recovery test
Objective:
To establish the recovery time frame for the area to attain the required conditions after the simulation of particle counts from class A & class B.
Test Equipment:
Non-viable particle counter dually calibrated.
Procedure:
Simulate and ensure to a count equivalent to that of grade C areas at rest by the following methods as below:
Personnel Movement.
Garments dusting.
Operate the Air borne non – viable particulate counter in the Class A & B areas and continuously operate the non viable particulate counter and note down the time taken after restoration as equivalent to class A & B.
Acceptance Criteria:
During restoration the particle count limits should fall in the class limits (as referred in standard ISO ).
Air borne particulate counter

33. HVAC

34. HVAC

35. HVAC

36. Definition of Conditions
HVAC
Definition of Conditions
air
as built
at rest
in operation

37. HVAC
Q & A Than Q