STANDARD OPERATING PROCEDURE

SOP No.: EN-XX Date of issue

Version No.: 11 VALIDATION OF HEATING Effective Date

VENTILATION AND AIR
CONDITIONING (HVAC) SYSTEM
Supersedes: Page 1 of 20
01.06.2020

PURPOSE:

To establish that the HVAC system is performing as it is supposed to perform by ensuring

that the;
a) Required Temperature/Relative Humidity and Pressure Gradient are within the limit of
acceptance criteria.
b) Particle count is within the limit of acceptance criteria.
c) Total Bacterial and Fungal Count is within the Limit of acceptance criteria.
d) Total Number of air changes and air velocity are within the limit of acceptance criteria.
e) Integrity of filters (EU9 and EU13 grade filters) are within the limit of acceptance criteria.
f) Airflow pattern of the system should be as per requirement.
g) Noise level is within the limit of acceptance criteria.
h) Pressure difference across filters is within the limit of acceptance criteria.
i) The percentage CFM at supply air, fresh air, return air and bleed filter is within the limit
of acceptance criteria.
j) Pressure difference with respect to atmosphere/adjacent area is within the limit of
acceptance criteria.
k) Recovery and Initial clean-up time are as per requirement.
l) Digital Hygrometer, manual control valves, locking arrangement of airflow control
dampers, safety locks on inspection doors and inspection lamp are in good operation.
SCOPE:

Applicable to Validation Procedures and Qualification carried out for Heating Ventilation and
Air Conditioning System.
RESPONSIBILITY:

Contractor: To carry out validation of HVAC system.

Engineering/Concerned area section officer: To supervise and provide the required

support during the exercise as well as area availability for execution of the tests.

APPROVED BY
PREPARED BY REVIEWED BY REVIEWED BY Quality Assurance
Engineering Engineering Head Quality Assurance Manager
Date: Date: Date: Date:
(QAP-01/F12/3)
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 2 of 20

DEFINITION:

At Rest Condition: Condition where the installation is complete with equipment installed
and operating in a manner as per requirement and with no personnel present.

Operational Condition: Agreed condition where the clean room or clean zone is functioning
in the specified manner, with equipment operating and with the specified number of
personnel present.

Acceptance Criteria: Measurable terms under which a test result will be considered
acceptable.

ACPH: The volume of air supplied to the room in m3/hr, divided by room volume in m3.

As Built: Condition where the clean room or clean zone is complete with all services
connected and functioning but with no equipment, furniture, material or personnel present.

Clean area / Clean room: An area or Room or Zone with defined environmental control of
particulate and microbial contamination, constructed and used in such a way as to reduce
the introduction, generation and retention of contaminants within the area.

Controlled area: An area within the facility in which specific environmental conditions and
procedures are defined, controlled and monitored to prevent degradation or cross
contamination of the product.

Unidirectional airflow: Controlled airflow through the entire cross-section of a clean room
or clean zone with a study velocity and airstreams that are considered to be parallel.

SAFETY:
1. Appropriate personal protective equipment to be worn during validation and to ensure
safety compliance during the validation exercise.
2. Persons recording the readings should put on appropriate personal
3. Protective Equipment.

2.0 PROCEDURE:

VALIDATION TEST AHU PROCEDURE: (CHECKS)

1. Start the AHU and check functioning of the system

2. Operation and locking arrangement of Airflow control Dampers
3. Noise Level
4. Operation of Inspection lamp
5. Pressure difference across final filter of AHU
6. Vibration of AHU
7. Temperature and Relative Humidity of area.

Prepared by
Sign/ Date: ____________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 3 of 20

8. Number of air changes per hour and Air Velocity measurements in the area
9. Relief air CFM, Bleed air filter and return air CFM through return air filter of AHU
10. Installed HEPA filter leakage test
11. Particle count test At Rest Condition and In Operation
12. Initial Clean up
13. Microbial Count
All above tests should be carried out by calibrated instruments.

2.0 AIR VELOCITY MEASUREMENTS AND AIR CHANGES PER HOUR

1. Ensure that the AHU "ON" prior to the start of the test.

2. Ensure that the instrument used to carry out the activity is calibrated and having a
valid calibration certificate.

3. Measure the air velocity at five different locations of grill/filter at a distance of about
150 to 300 mm (6" to 12 ") as shown below and for laminar air flow units measure the
air velocity at working level.

4. The measuring time at each location should be at least 10 seconds and average
reading should be taken. An instrument generated data should be recorded
immediately after every 10 seconds in case of use of air flow capture hood. Record the
reading in Air Velocity and ACPH test raw data sheet where necessary.

5. Calculate the average velocity of the air coming from the supply grill as per following
Formula:
Average Air Velocity (FPM) =

6. Calculate the air flow volume at each grill as per the following given below:

Air Flow volume (CFM of Grill) )

7. Calculate the total air flow from all the supply grill in the room and add the values to
get the total air flow in room (CFM)

Total air flow volume (CFM of room) =

I.e. Sum of the air flow volume at each supply grill of the room.

8. Calculate the number of air changes in the room as per the formula given below:

Number of air changes/hour in the room =

Prepared by
Sign/ Date: ____________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 4 of 20

3.0 PROCEDURE FOR INSTALLED HEPA FILTER LEAKAGE TEST.

1. Installed HEPA filter leakage testing to be carried out using Calibrated photometer.

2. An aerosol photometer having sensitivity 0.001 microgram/litre for 0.1 micron to 0.6-
micron particles of aerosolized Poly Alfa Olefin (PAO) over 0.001 microgram/litre to
100 microgram/litre measuring range (refer ISO 14644-3).

3. A PAO generator capable of producing a polydisperse test aerosol having more than
92 % of less than 1 micron in accordance with Institute of Environmental Sciences
(IES).

4. A report of installed HEPA filter leakage testing should be obtained from the
approved outside party along with raw data. The report and copy of instrument
generated raw data should be verified by Engineering.

4.0 Terminal HEPA Filter for Clean Room

1. Start the AHU whose filter system leakage test has to be carried out.

2. Carry out air velocity measurement before starting the PAO test.

3. Stop the AHU, as applicable.

4. Remove the Prefilter, intermediate filters, Fine and final filters of the system which are
installed in between PAO injection port and filter of which integrity is to be checked
and remove the terminal HEPA diffuser, if applicable.

5. Start the AHU whose filter system leakage test has to be carried out.

6. Ensure that there is power supply to the PAO photometer.

7. Direct the test aerosol at the return airport or fresh air intake of the AHU or supply
damper for above terminal HEPA or through the individual PAO injection port.

8. Put the photometer selector switch on UPSTREAM mode.

9. Remove the seal of the upstream port and connect the tube of photometer to the
upstream port of HEPA housing and measure the concentration. Ensure that the
upstream aerosol concentration is in between 20µg/L to 80µg/L.

10. After the required concentration has been obtained set the photometer for a reading of
100% using the upstream aerosol sample as a reference.

Prepared by
Sign/ Date: ____________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 5 of 20

11. This established 100% limit of measurement provides a read out that is a percentage
of the actual upstream level.

12. Wait until photometer displays 100% upstream concentration.

13. Remove the tube of photometer and close the upstream port of HEPA housing and
ensure no leakage through the port.

14. Check the seals of the upstream concentration port at the walkable ceiling and air
duct every after the qualification, requalification and validation process to ensure it is
airtight and that there is no leakage and if any leakage is observed, seal using food
grade silicon.

15. Put the photometer selector switch on CLEAR position.

16. Wait until photometer displays ‘0’ (Zero). It establishes the 0% baseline.

17. Turn the selector switch to ‘DOWNSTREAM’ position to permit sampling through the
scanning probe.

18. Measure the downstream concentration by holding the probe approximately 1 inch
away from the face of filter.

19. Ensure to scan the entire filter face including perimeters i.e. the filter housing, filter
frame, filter gasket and filter media; with the probe of photometer in overlapping
strokes, traversing at a scan rate of NMT 10 feet per minute (5cm/sec.) for a square
probe and about 30 feet per minute (15cm/sec) for rectangular probe approximately 1
inch/3 cm away from filter face.

20. Observe the percentage of leakage directly on the photometer and ensure leakage is
not more than 0.01% of upstream aerosol concentration.

21. Measurements of the aerosol upstream concentration of the filters should be done
before and after scanning for leaks to confirm the stability of the challenge aerosol
concentration.

22. If any leakage is observed through the seal/filter frame/filter housing of the filter, then
tighten the filter fixing nuts and check again for any leakages.

23. If leakage through filter media is more than 0.01% of the upstream aerosol
concentration, then replace the filter with new filter or repair it with food grade silicon
sealant.

24. If the filter is replaced with new filter, then check the integrity of new filter and ensure
that leakage is not more than 0.01% of upstream aerosol concentration.

Prepared by
Sign/ Date: ____________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 6 of 20

5.0 PROCEDURE FOR CARRYING OUT NON-VIABLE PARTICLE COUNT MONITORING.

1. Ensure the air borne particle counter is in calibrated state and calibration
certificate is available.

2. Particle count should be taken only after cleaning the AHU filters/ ducts/grills.

3. Before checking the particle count, run the AHU of the production area under test
for minimum of two hours without any activities in the area.

4. Non-viable particle count shall be carried out in "At rest" and in "Operational"
condition.

6.0 HOW TO CHECK.

1. Selection of sampling location:

Total sampling locations shall be identified as per the below table:

Number of sampling locations required with respect to clean room:

Area (m2) less Min number of Area (m2) Less Min number of sample
than or equal to sample locations than or equal to locations
2 1 76 15
4 2 104 16
6 3 108 17
8 4 116 18
10 5 148 19
24 6 156 20
28 7 192 21
32 8 232 22
36 9 276 23
52 10 352 24
56 11 436 25
64 12 636 26
68 13 1000 27
N = 27 X (area of clean
72 14 >1000
room in m2/ 1000

Prepared by
Sign/ Date: ____________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 7 of 20

1 Ensure that the sampling locations are evenly distributed through the area of the
clean room and position at a working level i.e. at approximately 1.5 meters.

2 All the identified locations shall be located on the room / Clean air device diagram to
be attached to the certificate.

3 All the identified locations shall be evenly distributed. Locations for monitoring shall be defined on the
risk-based approach considering the worst-case location which shall consists of the following but not
limited to:

Monitoring locations Justification

Near the door Maximum personnel I material movement
Chances of dead zone / Improper
Farthest point from the supply air
circulation
Near the operator working level Maximum operator interventions
Near the product processing Chances of maximum product risk
Dead zone formation I improper air
Near the corner
circulation
Near the return riser Chances of maximum unclean air
Geometric center To cover maximum room area

7.0 MONITORING PROCEDURE

1. Set the particle counter as per desired locations as per the clean room requirements
given in the section 7.1

2. Check the electrical supply to Air particle counter and switch “ON” the “mains" of the
machine. Go to the “Programme” mode with the help of feather touch keys provided on
control panel. Set the parameters as given below with the help of programme keys;

I. Set the timer for 6 seconds.

II. Set the cycles to 1 No.
III. Feed in the location code for the AHU/grill.
IV. Keep the system on manual mode.
V. Check the paper in printing compartment.
VI. Ensure that the paper is loaded in the printing compartment.

3. Set the sampling probe inlet facing into the predominant direction of the air flow
(Unidirectional air flow), in case where sampled air flow is not controlled or predominant
(non-unidirectional), the inlet of sampling probe shall be directed vertically Upward.

4. Connect the back-wash air filter of 0.2  size to the sampling nozzle on the machine and
take sufficient number of readings till the zero count is achieved.

Prepared by
Sign/ Date: ____________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 8 of 20

5. Mention the area code.

6. Take the printout, check for the acceptance criteria for particle size of 0.5 micrometer
and 5.0 micrometer. Also take a photocopy of the printout and attach to the report.

7. Repeat the procedure for each location.

8. Results for the individual particle count test locations should be compared with the ISO
classes of air cleanliness as per ISO 14644 Part I and Part II.

9. If the particle count is found beyond the designed parameter of the test area, check the
air handling unit filter integrity and leakages.

8.0 PROCEDURE FOR CHECKING OF AIR FLOW PATTERN/AIR FLOW VISUALIZATION

TEST

1. Airflow pattern checking should be done “at rest” condition.

.
2. Ensure that all the activities are stopped, and machines are put “OFF”.

3. Fire Alarm system should be deactivated.

4. Start the respective AHU/LAF of which the flow pattern is to be checked.

5. Introduce smoke by use of water fogger machine/dry ice/glycol at the supply grill and
there after the return riser. Observe the air flow.

6. Also observe the movement of air from one area to nearby area by generating smoke
near the door opening. This should be done when the door is closed and when the
door is open. Videography is to capture smoke flow while door is open and closed as
well as pressure differentials when door is open and closed.

7. Observe the smoke pattern and ensure the following.

I. The air flow pattern should ensure that all spaces within the controlled and
specified area are swept efficiently by the airflow, in order to ensure that both
contamination control and environmental control is achieved.
II. The smoke should be diffused uniformly at supply grill and pass through return
grill/riser.
III. There should not be any short-circuiting of airflow; dead pockets and the flow of air
should be unidirectional i.e. from supply to return.
IV. Airflow pattern of smoke in LAF unit should be laminar.
V. To check the pressure difference in the area, open the door slightly and hold the
smoke generator in the adjacent area, having a positive pressure.

Prepared by
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 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 9 of 20

VI. Smoke should pass from area under positive pressure (high pressure) to area
under negative pressure (low pressure).

9.0 PROCEDURE FOR RECOVERY TEST/CLEAN UP TIME TEST.

Initial clean up time test:

1. Ensure that HVAC, clean air cabinet are operational and catering area is clean.

2. Ensure that particle counter is calibrated, and certificate is available.

3. Ensure that non-viable particle counts are measured.

4. Identify the location in a clean room / Clean room cabinet where maximum count has
been observed.

5. Set the particle counter at a sampling rate of 1 CFM with delay time (time between
two sampling intervals) of not more than 10 seconds.

6. Read and record the initial particle count at the identified location in clean room
condition.

7. Contaminate the monitoring area by using aerosol generator by 100 or more times
more than the cleanliness class / target cleanliness level. Then commence
measurements.

8. Stop the particle contamination when desired contamination level is reached. Note
the time (T1). Continue the particle counting.

9. Note the time (T2) when particle count reduces up to the initial cleanliness class
level.

10. Calculate the cleanup time by deducting T2 – T1.

11. Observe the readings of Temperature, Relative Humidity and Particulate Matter
Count. Find the time from and at which Temperature, Relative humidity and
Particulate matter Count have been controlled to acceptance level i.e. initial clean up
time. If the above condition is not achieved take the readings at the interval of 10
minutes.

12. A location/sampling diagram showing the initial clean up test locations in the room
should be attached on the certificates.

10.0 For recovery period/ test:

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 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 10 of 20

1. This test is to be performed at the end of departmental activities and the cleanroom
area to be examined should be contaminated with an aerosol while the Air handling
units are in operation.

2. Position the particle counter at the agreed location and start the particle counter, record
the time and leave the room immediately.

3. Conclude Recovery/ Sweep Period by following formula.

Recovery/ Sweep Period = (Time at which desired cleanliness class is achieved) –

(Time at which particle counting is started.)

4. A location/sampling diagram showing the initial clean up test locations in the room
should be attached on the certificates.

11.0 PROCEDURE FOR DETERMINING % CFM ACROSS FILTERS OF AHU

a. Calculation of unit CFM:

1. Start the AHU.

2. Take size of the supply grills in feet, in the respective area.

3. Calculate the area of the supply grill in square feet;

Area (AS) = Length x Width

4. Take the velocity at 5 different locations of each supply grill in feet/minute with an
anemometer/ air flow capture hood.

5. Calculate Average velocity (VS)

6. Calculate the CFM at each supply grill (CFM) SUPPLY GRILL = VS x AS

This gives the CFM achieved through the supply grill.

7. Calculate area CFM: (CFM) UNIT = Sum of CFM at supply grills of the AHU.

12.0 Calculation of fresh air CFM:

1. Start the AHU.

2. Take size of the fresh air inlet in feet, of the respective AHU.

Prepared by
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 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 11 of 20

3. Calculate the area of fresh air inlet in square feet;

Area (AF) = Length x Width.

4. Take the velocity at 5 different locations of the fresh air inlet in feet/minute with the
Anemometer.

5. Calculate Average velocity (VF)

6. Calculate the fresh air CFM. (CFM) FRESH AIR = VF x AF

This gives the CFM achieved through the fresh air filter.
7. Calculate % CFM of fresh air across the fresh air filter by formula.

% CFM of fresh air across the fresh air filter =

% CFM of fresh air across fresh air filter should not be less than 10% of area CFM.

13.0 Relief air CFM calculation

b. Define the measuring plane perpendicular to the relief airflow and divide the
measuring plane into grid cells of equal area.

c. Airflow velocity shall be measured at the centre of each cell.

d. Use vane type / hot wire / air capture hood calibrated anemometer to check velocity
readings.

e. Take the velocity readings using vane type calibrated anemometer and calculate
average velocity at relief air filter.

f. Measure the face area of the relief air filter in ft2

g. Calculate the relief air CFM as:

Relief air CFM = (Avg. velocity at filter ft./min) x (Area of filter in ft2)

h. Record the same in report/certificate. Raw data to be instrument generated.

i. Acceptance Criteria: Relief air CFM shall not be more than 30% of total area CFM.

14.0 Return Air CFM Calculation:

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 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 12 of 20

1. Define the measuring plane perpendicular to the return airflow and divide the
measuring plane into grid cells of equal area.

2. Airflow velocity shall be measured at the centre of each cell.

3. Use calibrated vane type anemometer / hot wire anemometer / flow hood to check
velocity readings.

4. Take the velocity readings using calibrated vane type anemometer / hot wire
anemometer / flow hood and calculate average velocity at return air diffuser / grill /
riser.

5. Measure the face area of the return air diffuser / grill / riser in ft2.

6. Calculate the return air CFM using formula:

Return Air CFM = (Average return air velocity ft/min) x Area of filter (ft2)

Record the same in report/certificate. Raw data to be instrument generated.

15.0 Duct Leakage Measurement:

1. Switch ‘ON’ the AHU

2. If the AHUs have VFD, select to run the blower at constant speed at which pressure
difference is achieved between the cubicles.

3. Close all the doors in the area and ensure that there is no production activity in the
area.

4. Measure the velocity (ft/min) of airflow in the main supply duct immediately after the
main supply damper.

5. Measure the cross-sectional area of the duct at the velocity measurement point.

6. Calculate the supply airflow through duct as:

Supply airflow through duct (CFM) = Velocity of air in main supply duct (ft/min)
x Duct across sectional area (ft2).

7. Measure the velocity (ft/min) of airflow at each supply grill provided in cubicle.

8. Calculate the grill area (ft2).

9. Calculate the actual discharge of airflow in cubicles as:

Air flow discharge = Velocity of air at grill x Grill area x No. of grill.

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 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 13 of 20

10. Calculate the quantity of duct leakage as:

Duct leakage = Supply airflow through duct - Air flow discharge in cubicles.

11. Calculate the duct leakage as percentage of supply airflow as:

Duct leakage in % = (Duct leakage / supply airflow through duct) x 100.

12. If the duct leakages are more than 3%, consider them as significant and take carry out
duct leakage testing. Attend the leakages and again carry out the duct leakage
measurement.

13. Acceptance Criteria: Duct leakage shall not be more than 3%.

16.0 PROCEDURE FOR CALCULATION OF CFM OF DUST COLLECTOR (To be carried

out whenever applicable)

Calculation of cross-sectional area of suction duct:

1. Use a calibrated Vernier calliper or tape measure to determine the diameter of the
suction duct = D.

2. Determine the cross-sectional area, A given by the formula

Determining the velocity of air through the duct

3. Start the dust collector to create suction.

4. Place anemometer, (set in Ft/minute) at the distance of about 2 inches from the open
end the duct.

5. Record the velocity at four different positions.

Calculate CFM of dust collector given by the formula.

CFM of duct = (VA) x A in Ft³/minute.

17.0 PROCEDURE FOR CHECKING OF NOISE LEVEL BY DB METER.

1.Put the ‘ON-OFF’ selector switch on DB meter to ‘ON’ position.

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Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 14 of 20

2.Put the ‘UNIT’ selection switch to desire position i.e. in which unit you must take the
reading of noise level.

3.Hold the DB meter about one meter from the machine whose noise level to be
checked.

4.Record the reading from the digital display provided on the DB meter and maintain the
record in annexure; …………………….

5.Repeat procedure in 2 different positions and take the average

6.Repeat the procedure for other machines in the same manner

7.Calibration of the instrument/noise level meter:

8.The instrument needs to be calibrated from outside approved agency.

9.Calibration of equipment should be carried out once in a year.

18.0 PROCEDURE FOR LUX LEVEL MEASUREMENT

1. Switch “ON” the tube lights mains.

2. Take Lux meter.

3. Take Lux reading at five different locations at working level (not less than 300 lux).

4. Take the reading in Lux as in the Annexure …………………... and record the same.

19. 0 FREQUENCY:

Summary table of frequency and acceptance criteria for tests carried out.

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 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 15 of 20

Test Acceptance criteria Frequency

Operation of Manual
Should be operational Once in a Year
Control Valves.
Operation and
Supply and return air ducting should be
locking
operational and its locking arrangement
arrangement Once in a Year
is properly holding the damper to its
check of airflow
position.
control dampers.
Air velocity Average measured clean air velocity
Once in a Year
measurements should meet the design criteria.
The smoke should be diffused uniformly
Airflow Pattern test
at supply air location to room and pass
(Room and Once in two years
through the riser’s location as well as
Corridor)
from positive to negative pressure area.
No. of particles / m3
Particle size Limits
Once in six
ISO Class 5
months
0.5µ 3520
5µ 29
ISO Class 6
Particle Count 0.5µ 35 200
(At Rest Condition) 5µ 293
ISO Class 7
Once in six
0.5µ 352 000
months
5µ 2 930
ISO Class 8
0.5µ 3 520 000
5µ 29300
No. of particles / m3
Particle size Limits
Once in six
ISO Class 5
months
0.5µ 35200
5µ 293
ISO Class 6
Particle Count
0.5µ 352 000
(In Operational
5µ 2930
Condition)
ISO Class 7
Once in six
0.5µ 3520 000
months
5µ 29300
ISO Class 8
0.5µ
Not defined
5µ
Noise level
NMT 90dB Once in a Year
Monitoring

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 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 16 of 20

Test Acceptance criteria Frequency

Operation of Manual
Should be operational Once in a Year
Control Valves.
Operation and
Supply and return air ducting should be
locking
operational and its locking arrangement
arrangement Once in a Year
is properly holding the damper to its
check of airflow
position.
control dampers.
Air velocity Average measured clean air velocity
Once in a Year
measurements should meet the design criteria.
The smoke should be diffused uniformly
Airflow Pattern test
at supply air location to room and pass
(Room and Once in two years
through the riser’s location as well as
Corridor)
from positive to negative pressure area.
Drain Tray
Condensate collection tray should be
Condition and
clean, no water leakage and water Once in a Year
Condensate
accumulation should be observed.
Drainage system.
HVAC System should be operational by the switch
Once in a Year
Inspection Lamp. provided.
Manometer tubes should not be pinched
or kinked and should be intact.
Condition of
Manometer indicator should be on “Zero” Once in a Year
Manometer Tubing.
position while HVAC System is in “OFF”
condition.
Blower Motor Should be in the limit as per its designed
Once in a Year
Current rating
Pressure Difference
across final Filter
4-40mm WG Once in a Year
(EU9) of HVAC
System
Differential
Pressure across
4-24mm WG Once in a Year
filter
Bank (EU-7)
Pressure Difference
1.0 - 3.0 mmWC
with respect to
Once in a Year
atmosphere/adjace
0.5 – 2.0 mmWC
nt area.
Number of Air 20 for ISO class 8 areas, 40 for ISO
Once in a Year
changes per hour. class 7 areas.
% cfm at fresh air
Fresh air inlet should be NLT 10% Once in a Year
filter.
Temperature and
22±3 ºC and 45-60% Once in a Year
Relative Humidity

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Sign/ Date: ____________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 17 of 20

Test Acceptance criteria Frequency

Operation of Manual
Should be operational Once in a Year
Control Valves.
Operation and
Supply and return air ducting should be
locking
operational and its locking arrangement
arrangement Once in a Year
is properly holding the damper to its
check of airflow
position.
control dampers.
Air velocity Average measured clean air velocity
Once in a Year
measurements should meet the design criteria.
The smoke should be diffused uniformly
Airflow Pattern test
at supply air location to room and pass
(Room and Once in two years
through the riser’s location as well as
Corridor)
from positive to negative pressure area.
Particulate matter count
Recovery Test should be achieved within 15 Once in two years
minutes
Settle Plate
Test Limits
ISO Class 5
Bacterial NIL
Fungal NIL
ISO Class 7
Bacterial 20 cfu/plate
Fungal NIL
ISO Class 8
Microbiological Bacterial 90 cfu/plate
Testing Fungal 10 cfu/plate
Once in a Year
(Air Sampling and SettleAir Sampling
Plate) Test Limits
ISO Class 5
Bacterial 1 cfu/plate
Fungal NIL
ISO Class 7
Bacterial 16 cfu/plate
Fungal NIL
ISO Class 8
Bacterial 400 cfu/plate
Fungal 16 cfu/plate
% cfm across bleed
Should be as per the design of
filter of HVAC Once in a Year
area
system

Prepared by
Sign/ Date: ____________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 18 of 20

Test Acceptance criteria Frequency

Operation of Manual
Should be operational Once in a Year
Control Valves.
Operation and
Supply and return air ducting should be
locking
operational and its locking arrangement
arrangement Once in a Year
is properly holding the damper to its
check of airflow
position.
control dampers.
Air velocity Average measured clean air velocity
Once in a Year
measurements should meet the design criteria.
The smoke should be diffused uniformly
Airflow Pattern test
at supply air location to room and pass
(Room and Once in two years
through the riser’s location as well as
Corridor)
from positive to negative pressure area.
1. For EU13 filters: Any leakage should
Installed Filter not be more than 0.01% of Upstream
Leakage challenge aerosol concentration.
Once in two years
Testing 2. For EU9 filters: Any leakage should
not be more than 0.01 % of Upstream
challenge Aerosol concentration.
Particulate matter, temperature and RH
Initial Clean Up should be achieved within 30 minutes Once in two years
after AHU is put on.

20.0 CHECKING FOR PRESSURE IN CUBICLE WITH RESPECT TO ADJACENT

PROCEDURE

1. Ensure that the AHU’s in all areas are operational for 10 minutes.

2. Ensure the ‘0’ reading of the manometer while the door is open, if not, adjust the
reading to’0’ while the door is still open.

3. Ensure that the door of the adjacent areas are in closed condition.

4. Read the value on gauge, which is directly corresponding to the indicator needle.

5. Record the observation in the respective format.

6. If pressure difference is not within limit, inform Engineering on the same and
activity.

21.0 ANNEXURES:

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Sign/ Date: ____________________
 STANDARD OPERATING PROCEDURE
SOP No.: EN-XX
Approval Date:
VALIDATION OF HEATING
Version No.: 01 VENTILATION AND SIR
CONDITIONING SYSTEM (HVAC) AND
Next Review Date: AREA Page 19 of 20

Annexure Annexure Name To be used as

Number
ENG-xx-A1 Differential Pressure Record Bound Book

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Sign/ Date: ____________________