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Validation
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What is HVAC system?
Objective of HVAC.
What is the Full form of HVAC?
HVAC basic parts.
HVAC OBJECTIVE
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.
FULL FORM OF HVAC
In the word HVAC “H” stands for Heating, “V” stands for Ventilation 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
What is the Full form of HVAC? in the air, and the movement of the air in the occupied space.
&
HVAC basic parts. BASIC HVAC PARTS
Furnace
Heat Exchanger
Evaporator Coil
Condensing Unit
Refrigerant Lines
Thermostat
Ducts
Vents
HVAC Validation
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
HVAC validation and Reference Requirement Specifications (URS); to ensure that the facility, equipment, and environment meet
Guidelines defined regulatory requirements; to ensure that the facility, equipment, and its environment
function together as a system to meet defined standards.
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.
Air Velocity, Air Volume and
Distribution Test (AIR 12 months
12 months
HVAC validation Test
ISO-6-8: 12 months
NON VIABLE PARTICLE COUNT
TEST ISO-5: 6months
NMT 20
Recovery test Not required Not required NMT 20 mins.
mins.
0.3µ
HVAC validation Test
NMT
PAO Test N/A N/A NMT 0.01%
0.01%
90 ± 20%
Airflow velocity N/A N/A N/A
FPM
Yes,
Airflow visualization N/A N/A Yes, smoke test smoke
test
Air Velocity, Air Volume and Distribution Test (AIR BALANCING)
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.
HVAC validation test methodology 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.
Calculation of Air Change Per Hour:
Actual CFM x 60
ACPH =
Volume of Area
HEPA Filter Integrity Test (PAO test)
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.
HVAC validation test methodology
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.
NON VIABLE PARTICLE COUNT TEST
Area of clean room (m2) less than or equal to Min. number of sample location to be tested NL
2 1
HVAC validation test methodology
4 2
6 3
If area is more than 1000 m2
> 1000 mtr N = 27[A/1000]
0.5µ 5.0µ
ISO class 5 3500 29
AIR FLOW PATTERN TEST
Equipment Used: Smoke/Fog generator, 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.
HVAC validation test methodology
Intense smoke will be generated showing the airflow direction. Take the video shooting from upside down towards the return
filter.
Acceptance Criteria:
Air should flow from the higher-pressure zone to low pressure zone.
The air should flow towards the return air filter or grill.
RECOVERY TIME TEST
Thank You
Ankit Rana
+91 9054007240
Info.pharmawalesolutions@gmail.com