The document discusses HVAC (heating, ventilation, and air conditioning) validation. It defines HVAC, explains its objectives and basic parts. It then discusses HVAC validation guidelines, the types of tests performed during validation including air distribution testing, filter integrity testing, non-viable particle counting, airflow visualization, and recovery time testing. The document provides details on the methodologies and acceptance criteria for each test. It concludes with discussing the importance and frequency of preventive maintenance for HVAC systems.

1. HVAC (AHU)
Validation
Noor Nabi
Deputy ManagerValidation & Qualification

2.  What is HVAC system?
 Objective of HVAC.
 What is the Full form of HVAC?
 HVAC basic parts.
 HVAC validation and Reference Guidelines
 Test perform during HVAC Validation.
 Frequency of HVAC validation test or Requalification.
 Preventive maintenance of HVAC.
Contents

3. The full form of HVAC system is Heating, Ventilation, and Air Conditioning. HVAC systems generally control
temperature, humidity, and quality of air in a building or any occupied space. The main goal of the HVAC system is to
create and maintain a comfortable environment for the occupant within a building.
 There are basically seven main processes required to achieve the full meaning of HVAC and they are listed and
explained below:-
I.
II.
III.
IV.
V.
VI.
VII.
Heating
Cooling
Humidifying
Dehumidifying
Cleaning
Ventilation
Air Movement
WhatisHVACSystem? &
ObjectivesofHVACSystem
The main objective of an HVAC system is to provide a comfortable environment for the humans living in that space,
but there are many other objectives for using this system: creating a suitable environment for farm animals for their
optimal health, creating a suitable environment for the patients in a hospital, maintaining a suitable temperature for
cold food storage, clean room maintain in pharma industries and many more such type of objectives.

HVAC OBJECTIVE

HVAC SYSTEM

4. 
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In the word HVAC “H” stands for Heating, “V” stands forVentilation and “AC” stands for Air Conditioning.
H = Heating (Increase or decrease the temperature of water or air)
V =Ventilation (Supply right amount of clean and fresh air)
AC = Air Conditioning
As mentioned above, the term “HVAC” when properly used means the total control of temperature,
moisture in the air (humidity), the supply of fresh outside air for ventilation, filtration of airborne particles
in the air, and the movement of the air in the occupied space.
WhatistheFullformofHVAC?
&
HVACbasicparts.
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Furnace
Heat Exchanger
Evaporator Coil
CondensingUnit
Refrigerant Lines
Thermostat
Ducts
Vents

BASIC HVAC PARTS
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FULL FORM OF HVAC

5. HVAC is subjected to the following set of performance test to demonstrate and establish that the
equipment is working under within its designs specifications.
As well as
HVAC Validation is performed for a variety of reasons. To ensure that the design of the facility is fit
for its intended purpose; to ensure that the facility, equipment, and environment meets User
Requirement Specifications (URS); to ensure that the facility, equipment, and environment meet
defined regulatory requirements; to ensure that the facility, equipment, and its environment
function together as a system to meet defined standards.
HVAC validationandReference
Guidelines
HVAC validations as per ISO 14644-1,2,3, EU GMP Annex-15 GMP, WHO-TRS-937, WHO-TRS-961,
Schedule M (National Regulatory Body) guidelines for all room classifications.

HVAC Validation reference guidelines

HVAC Validation

6. Distribution Test (AIR
test)
TEST
STUDY
HVAC
validation
Test
HVAC
validation
Test
frequency
Air Velocity, Air Volume and
BALANCING)
HEPA Filter Integrity Test (PAO
NON VIABLE PARTICLE COUNT
RECOVERY TIME TEST
AIR FLOW PATTERN
12 months
12 months
ISO-6-8: 12 months
ISO-5: 6months
24 months
24 months

7. zone*
mins.
filters
0.01%
FPM
HVAC
validation
Test
Variables Normal area Protected area Controlled area Clean
Recovery test Not required Not required NMT 20 mins. NMT 20
Filters Not required 10µ filters 0.3µ filters
0.3µ
PAO Test N/A N/A NMT 0.01%
NMT
Air changes Not required N/A
ISO class 6 > 60/hour
ISO class 7 > 40/hour N/A
ISO class 8 > 20/hour
Airflow velocity N/A N/A N/A 90 ± 20%
Yes,
Airflow visualization N/A N/A Yes, smoke test smoke
test

8. Equipment Used: Anemometer (vane type/Hot Wire)
Methodology:
To demonstrate that the air system is balanced and capable of delivering sufficient air volume to maintain a minimum
cross sectional velocity under the absolute filter
These tests are executed in every room where an absolute terminal filter module is installed.
Keep the Hot wire Anemometer range as 0 - 1500 FPM.
Keep the probe at 150 mm below the filter grill and velocity recording to be noted.
One filter requires minimum 5 tests spots. Measure the air velocity at 4 corners and 1 center of the filter. CFM = Avg.
of Air Velocity x Area of supply grill
Measure velocity at the center of each grid at the 6-inch height.
Allow no object within 10 ft. of the Anemometer. Minimize the no. of people during at rest testing.
Measurement should be taken for a minimum of 10 seconds.
Calculate the FPM and Air changes per hour.
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HVAC validationtestmethodology
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Calculation of Air Change Per Hour:
ACPH =
Actual CFM x 60
Volume of Area

Air Velocity, Air Volume and Distribution Test (AIR BALANCING)

9. Equipment Used: PAO smoke generator & Aerosol Photometer
Methodology:
To demonstrate that the air system is balanced and capable of delivering sufficient air volume to maintain a minimum
cross sectional velocity under the absolute filter
Filter integrity test is performed after Operational air velocities have been verified and adjusted.
Introduce the PAO / Aerosol as a challenge agent into the upstream side of the filter system and
searching for leaks downstream with an aerosol photometer.
Adjust the aerosol photometer such that the pressure is in the range of 1.5 to 2 kg or 20psi (Pascal per
inch).
Position of the smoke generator to the pre filter so that PAO aerosol will be introduced into the
upstream system ahead of HEPA filters.
Once the 100% setting are established at the upstream sides turn the instrument knob to downstream.
Keep the scanning probe1inch below the HEPA filter grill, and start scanning the HEPA filter face area by
holding the probe one inch away from the filter.
Ensure that the scanning speed does not exceed 20 ft /min velocity.
If any leak is observed, then take out the grill and retest it. Assure that the leakage is coming through the
side or housing of the fitment part or HEPA Filter itself.
If fitment leakage is there, tightening the HEPA filter fitment with pressure plate can arrest it. And if the
HEPA filter leakage is still there, the joint can be sealed by silicon sealant, but should not exceed more
than 5% of the surface area.
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HVAC validationtestmethodology
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HEPA Filter Integrity Test (PAO test)

10. Equipment Used: Particle Counter
Methodology:
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Ensure that the area should be cleaned and air handling unit is kept ON for at least two hours before taking particle count.
Sample one cubic feet air per minute under normalized mode.
Identify the number as per 14644-1: 2015 list below-
HVAC validationtestmethodology
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The number of locations shall be rounded up to the nearest higher number.
If the number of location is one, then minimum two samples shall be taken at that location
Identify the locations in the room cover critical locations first.
Set the Particle Counter sample time is minimum 01 min. for class ISO-6, ISO-7, ISO-8 at working height of about 1 meter from the ground level collect the data
for 0.5 µ and 5.0 µ particle for rest condition.
Set the Particle Counter sample time is minimum 1000 Liters for class ISO-5 at working height of about 1 meter from the ground level collect the data for 0.5 µ
and 5.0 µ particle for both rest & operation condition.

Area of clean room (m2) less than or equal to Min. number of sample location to be testedNL
2 1
4 2
6 3
If area is more than 1000 m2
> 1000 mtr N = 27[A/1000]

NON VIABLE PARTICLE COUNT TEST

11. HVAC validationtestmethodology
Grade
Maximumnumber of permitted particles per cubic meter equal to or
above
At Operation
0.5µ 5.0µ
ISO class 5 3500 29
Maximumnumber of permitted particlesper cubic meter equal to or
above
Grade
At rest
0.5µ 5.0µ
ISO class 5 3520 -
ISO class 6 35,200 293
ISO class 7 352,000 2,930
ISO class 8 35,200,00 29,300

NON VIABLE PARTICLE COUNT TEST Acceptance Criteria:

12. Equipment Used: Smoke/Foggenerator,Video Camera,Dry ice/ Glycerin+ Water
Methodology:
Glycerin + water should be used for smoke test.
During airflow test should be used properly gowning as per sop.
For results recording provision of video shooting should be made.
Put ON the AHU of the area for which smoke test is to be done.
Generate the fume through the smoke generator and hold it perpendicular to direction of the air flow.
Intensesmoke will be generatedshowingthe airflow direction.Take the video shootingfrom upside downtowards the return
filter.
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HVAC validationtestmethodology
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AcceptanceCriteria:
Air should flow from the higher-pressure zone to low pressure zone.
The air should flow towards the return air filter or grill.

AIR FLOW PATTERN TEST

13. Equipment Used: Particle counter

Methodology:
 Glycerin + water should be used for smoke test.
Clean the area and all the equipments before starting the counter.
Set the particles counter and sampling probe should be positioned vertically upward.
Contaminate the area by opening the doors of the room and increasing the man movement in the room. Contaminate the
room until the particle number goes beyond the acceptance limit and reading shall be further continued to get the higher
level.
Take the printout of the maximum particle number in the area.
Start the particle counter with at least 10 cycles set to the particle counter.
The number of particles shall decrease slowly and at the end it will come to normal cleanliness class condition.
The time shall be calculated from the start of the particle count to the time where the number of particles comes under
the limit of the desired cleanliness class.
The recovery period shall be given as the time required getting the classified class conditions from unclassified
conditions, shall be express in minutes and area should be recovered within 20 minutes.
HVAC validationtestmethodology

RECOVERY TIME TEST

14. HVACPreventivemaintenance
PMissoimportanttomaintainHVAC
efficiency .
Itshouldbeperformedquarterly.

Preventive maintenance of HVAC