Key_issues_in_Qualification_of_HVAC_systems_1687758626.pdf

HVAC validation

1. 1
Key issues in
Qualification of
HVAC systems

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

3. 3
HVAC Applications…
1.SYNTHETIC FIBRE
2.PHARMACEUTICALS
3.HOSPITALS & MEDICAL RESEARCH CENTRE
4.THEATRE / AUDITORIUM / MULTIPLEX
5.EMBASSIES, AIRPORT,AIRLINES
6.NON MEDICAL RESEARCH CENTRE
7.OTHER INDUSTRIES & PROCESS PLANTS
8.OFFICES / HOTELS
9.BANKS…….
HVAC

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

5. 5
HVAC
1.OBJECTIVE
2.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
5.METHODOLOGY
6.Summary and Conclusion
7.Design Qualification Approval
DESIGN QUALIFICATION

6. 6
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
INSTALLATION QUALIFICATION
HVAC
The purpose of IQ is to verify and document the
quality, installation and integrity of the HVAC system.

7. 7
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
OPERATIONAL QUALIFICATION
HVAC
The purpose of OQ is to establish, through documented testing, that all
critical components are capable of operating within established limits
and tolerances.

8. HVAC
8PERFORMANCE QUALIFICATION
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
The purpose of PQ is to verify and document that an HVAC system
provides acceptable operational control under ‘ full operational ‘
conditions.

9. 9
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
Re-qualification
HVAC

10. 10
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 2
N/A 2, 3
2, 3 Optional
2 2
2 N/A
2 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
N/A 2
2 2,3
N/A 2,3
HVAC

11. HVAC
11
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
123.2 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.
Anemome
ter

13. 13
HVAC
3.2 Air Velocity Measurement and Calculation of Air Changes Cont…
CLASS Number of Air Changes / Hour
CLASS 100 NLT 250
CLASS 10 000 60 + 10 %
CLASS 1 00 000 40 + 10 %

14. 14
HVAC
3.3 Integrity (Leak) test of HEPA filters
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 80-100 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 ft
3
/ 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 99.97 efficiency HEPA Filters and 0.001%
for 99.997 Efficiency.
Aerosol
Photometer
Aerosol
Generator

15. 15
HVAC
3.3 Integrity test of HEPA filters Cont….
Filter
Grade
Efficiency Filter Type
U 17 99.99995 ULPA
U 16 99.9995 ULPA
U 15 99.999 ULPA
H 14 99.99 HEPA
H 13 99.97 HEPA
H 12 99.9 HEPA
H 11 95 HEPA
Filter Specifications

16. 16
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. 17
HVAC
3.5 Temperature and Relative Humidity Test
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
Hygro meter
Sensor

18. 18
HVAC
3.6 Air Flow Direction Test
Objective
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.
Observe the flow of Dry Ice / TiCl4 smoke at the filter downstream.
Videotape the smoke flow pattern.
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. 19
Air Flow
Direction
⚫Location of filter, doors, return air risers etc..
HVAC

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

21. 21
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 14644-1.
Air borne particulate
counter

22. 22
HVAC
3.7 Cleanliness Class Verification (Non viable Particle Count) Cont….
ISO 14644-1
ISO 14644-1
> 0.1 m
(Particles /
Mt
3
)
> 0.2 m
(Particles /
Mt
3
)
> 0.3 m
(Particles
/ Mt
3
)
> 0.5 m
(Particles /
Mt
3
)
> 1.0 m
(Particles /
Mt
3
)
> 5.0 m
(Particles /
Mt
3
)
ISO 1 1 2 0 0 0 0
ISO 2 100 24 10 4 0 0
ISO 3 1 000 237 102 35 8 0
ISO 4 10 000 2 370 1 020 352 83 0
ISO 5 1 00 000 23 700 10 200 3 520 832 29
ISO 6 10 00 0002 37 0001 02 000 35 200 8 320 293
ISO 7 NA NA NA 3 52 000 83 200 2 930
ISO 8 NA NA NA 35 20 000 8 32 000 29 300
ISO 9 NA NA NA 3 52 00 00083 20 0002 93 000

23. 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 / Mt
3
)
> 0.2 m
(Particles / Mt
3
)
> 0.3 m
(Particles / Mt
3
)
> 0.5 m
(Particles / Mt
3
)
> 5.0 m
(Particles / Mt
3
)
1 35 7.5 3 1 NA
10 350 75 30 10 NA
100 NA 750 300 100 NA
1 000 NA NA NA 1 000 7
10 000 NA NA NA 10 000 70
1 00 000 NA NA NA 1 00 000 700

24. 24
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 / Mt
3
)
> 5.0 m
(Particles / Mt
3
)
> 0.5 m
(Particles / Mt
3
)
> 5.0 m
(Particles / Mt
3
)
GRADE A 3 500 1 3 500 1
GRADE B 3 500 1 3 50 000 2 000
GRADE C 3 50 000 2 000 35 00 000 20 000
GRADE D 35 00 000 20 000 Not defined Not defined
GRADE E Not defined Not defined Not defined Not defined

25. 25
CLASS
FED 209 E CLASS ISO 14644-1
EU GGMP
(in operation)
> 0.5 m
(Particles /
Mt
3
)
> 5.0 m
(Particles /
Mt
3
)
> 0.5 m
(Particles /
Mt
3
)
> 5.0 m
(Particles /
Mt
3
)
> 0.5 m
(Particles /
Mt
3
)
> 5.0 m
(Particles /
Mt
3
)
Class 100 /
ISO 5 /
Grade A
100 NA 3 520 29 3 500 1
Class 10 000
/ ISO 7 /
Grade C
10 000 70 3 52 000 2 930 35 00 000 20 000
Class 100 000 /
ISO 8 /
Grade D
1 00 000 700 35 20 000 29 300
Not
defined
Not
defined
HVAC
3.7 Cleanliness Class Verification (Non viable Particle Count) Cont….
FED STD 209 E / ISO 14644-1 / EU GGMP

26. 26
HVAC
3.8 Sound level Test
Objective:
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. 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 NMT 80

28. 28
HVAC
3.9 Light Level Test
Objective:
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. 29
HVAC
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 NLT 300
3.9 Light Level Test Cont….

30. 30
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. 31
HVAC
Locations
Microbial Count
Plate Exposure
[CFU/plate]
Air Sampling
[CFU/ 1 m
3
]
Alert Action Alert Action
Class 100 --- <1 ----- <1
Class 10000 3 5 3 5
Class 100000 20 30 20 30
3.10 Air Borne Viable Particle Monitoring Cont…

32. 32
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 14644-1).
Air borne particulate
counter

33. 33
HVAC

34. 34
HVAC

35. 35
HVAC

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

37. 37
HVAC
Q & A
Than Q