1. Air Velocity Test
1.0 PURPOSE
To describe a procedure for carrying out Air Velocity Test.
2.0 SCOPE
This Procedure includes guidelines for carrying out the Air Velocity Test.
3.0 RESPONSIBILITY
Validation Team and Engineering/Maintenance Department is responsible for
carry out the Test.
4.0 PRINCIPLE
This test is performed to determine the average airflow velocity, volume and
Uniformity in a clean room, as well as to determine air supply volume flow rate.
Air velocity test will be performed and the results will be required to determine
the air changes per hour for the clean room.
5.0 DEFINITION
5.1 Air Changes per Hour
The rate of air exchange in a particular room is expressed as Air Changes
Per Hour and is calculated by dividing the total volume of air delivered in
the time unit by the volume of the space.
5.2 Non-Unidirectional air flow
Air distribution where the supply air entering the clean zone mixes with
the internal air by means of induction.
5.3 Unidirectional Airflow
Controlled airflow through the entire cross section of a clean zone with
steady velocity approximately parallel streamlines.
6.0 PROCEDURE
6.1 Airflow velocity measurement in unidirectional airflow
6.1.1 Before starting the work take the details of the whole area that to
be validated.
6.1.2 Clean all the instruments with IPA before entering the clean area.
6.1.3 System should be kept ON before starting the measurements.

2. 6.1.4 Hot wire Anemometer or Vane type Anemometer is used for
measuring air velocity.
6.1.5 Measure the filter size of the installation for which the test is to be
carried out.
6.1.6 Measuring point should be defined at a distance between 150mm
from the filter face.
6.1.7 For measuring the filter face velocity, the distance should be about
150mm, and for checking the uniformity, it should be more than
300mm.Measuring time at each position should be at least 10
second, and the average,maximum and minimum values should be
recorded.
6.1.8 Note down the readings.
6.2 Airflow velocity measurement for non-unidirectional airflow
6.2.1 Before starting the work take the details of the whole area that to
be validated.
6.2.2 Clean all the instruments with IPA before entering the clean area.
6.2.3 System should be kept ON before starting the measurements.
6.2.4 Hot wire Anemometer or Vane type Anemometer is used for
measuring air velocity.
6.2.5 Measure the filter size of the installation for which the test is to be
carried out.
6.2.6 Measuring point should be defined at a distance 150mm from the
filter face.
6.2.7 Measuring time at each position should be at least 10 second.
6.2.8 Calculate the average velocity for each filter.
6.2.9 Calculate the CFM of each filter by using following formula;
CFM=Avg.Velocity (fpm) x Area of grill (ft2)
6.2.10 Calculate the total CFM of room by adding each filter CFM.
6.2.11 Find out the ACPH by using following formula:
No. of Air Changes /Hr = Total CFM X 60
3
Room Volume (ft )
6.2.12 Calculated the air changes should not less than the designed air
changes.
6.2.13 If the air changes are lesser than required, adjust the dampers to
desired CFM.
6.2.14 Note down the readings.

3. 7.0 REFERENCE
ISO 14644
8.0 ABBREVIATION
SOP Standard Operating Procedure
ISO International Standard Operating
CFM Cubic Feet per Minute
Ft Feet
Avg Average
Hr Hour
ACPH Air Changes per Hour

4. DOP/PAO leak integrity test.
1.0 PURPOSE
To describe a procedure for carrying out DOP/PAO leak integrity test.
2.0 SCOPE
This Procedure includes guidelines for detection of defects or pinhole leaks of HEPA
filter
3.0 RESPONSIBILITY
Validation Team and Engineers/ Maintenance Department is responsible for carryout the
Test.
4.0 PRINCIPLE
This test is performed to confirm that the HEPA filter is properly installed by verifying
the absence of bypass leakage in the installation and the filters are free of defects and
leaks in the filter frame and gasket seals, leaks in the filter bank framework. The test is
performed by injecting and aerosol challenge upstream of the filters and immediately
scanning down stream of the filters and supporting frame.
5.0 DEFINITION
5.1 DOP (Di octyl Phthalate) / PAO (Poly Alfa Olefin)
A mono-dispersed test aerosol of sub-micron particles, generated to challenge (evaluate
integrity ) of HEPA filters for HVAC
5.2 Aerosol Challenge
Challenging of filter or an installed filter system by test aerosol.
5.3 Aerosol Generator
System wherein aerosol is mixed with particle –free dilution air in a known volumetric
ratio to reduce concentration.
5.4 Installed Filter Leakage Test
Test performed to confirm that the final filters are properly installed by verifying that
there
is absence of bypass leakage in the installation, and that the filters and the grid system are
free of defects and leak.
5.4 Installed Filter Leakage Test
Test performed to confirm that the final filters are properly installed by verifying that
there
is absence of bypass leakage in the installation, and that the filters and the grid system
are free of defects and leak.
5.5 Aerosol
A gaseous suspension of fine (100µm or smaller in size) solid or liquid particles.

5. 5.6 Aerosol Photometer
Light-scattering mass concentration indicating instrument which uses a forward
Scattered optical chamber to make measurements.
5.7 Scanning
Method for disclosing leaks in units, whereby the probe inlet of an aerosol photometer is
moved in overlapping strokes across the defined filter area.
6.0 PROCEDURE
6.1 Before starting the work take the details of the whole area that to be validated.
6.2 Ask engineering / maintenance person to arrange single phase power supply as
well as air connection with 20psi (1.5kg) pressure.
6.3 Clean all the instruments with IPA before entering the clean area
6.4 Ensure that the floor and area as well as Equipment is visually cleaned.
6.5 System should be kept ON before starting the measurements.
6.6 Connect the Spike Guard to Photometer before starting it.
6.7 Start the air to generate the aerosol particles at 20psi pressure.
6.8 Direct the generator face to the return air point or fresh air intake of the AHU.
6.9 Take a tube and connect on end to the filter face Upstream port and other to the
photometer in Upstream mode.
6.10 Switch ON the photometer and set it to zero.
6.11 Put the photometer to upstream mode and note the reading, the reading should be
in between 20mg/Ltr to 80mg/Ltr.
6.12 If it is between the above range then set the value to 100%, wait until the
photometer displays 100% upstream concentration.
6.13 Put the photometer switch on clear mode and enter zero for machine to become
zero.
6.14 Wait until photometer display ‘0’ (zero).
6.15 Now put the switch to down stream mode and scan the filter by holding the probe
approximately one inch away from the filter face.
6.16 Scan the corners of HEPA filter for checking the installation leakages.
6.17 If the reading on the photometer is more than 0.01%, rectify the leakages by
tightening the locking bolts.
6.18 Repair patches on filters should not exceed maximum of 5% of the total filter
face area and the maximum width x length of each patch should not be more than
1.5 inches. Total number of patches should not exceed 5 numbers / filters.
6.19 Note down the final readings after rectification.

6. 7.0 REFERENCE
ISO 14644
8.0 ABBREVIATION
SOP Standard Operating Procedure
ISO International Standard Operating
CFM Cubic Feet per Minute
Psi Pascal per Square Inch
HVAC Heating Ventilation and Air Conditioning
AHU Air Handling Unit

7. Non- Viable Particle Count Test.
1.0 PURPOSE
To describe a procedure for carrying out Non- Viable Particle Count Test.
4.0 SCOPE
This Procedure includes guidelines for Carrying out Non-Viable Particle Count Test
which includes the classification of air classification of air cleanliness in clean rooms and
associated controlled environments in terms of Concentration of airborne particles.
5.0 RESPONSIBILITY
Validation Team and Engineers/ Maintenance Department is responsible for carryout the
Test.
4.0 PRINCIPLE
This test is method specifies the measurement of air borne particle concentrations with
size distributions having a threshold size between 0.5µm and 5.0µm. Measurements can
be made in any of three defined occupancy states as-built, at-rest and operational. The
measurements are made to certify the cleanliness classification.
5.0 DEFINITION
5.1 AIRBORNE PARTICLES
5.1.1 Particle
Solid or liquid object which, for purposes of classification of air
cleanliness, falls with in a cumulative distribution that is based upon a
threshold (lower limit) size in the range from 0.1µm to 5.0µm.
5.1.2 Particle Size
Diameter of a sphere that produces a response, by a given particle-sizing
instruments, that is equivalent to the response produced by the particle
being measured.
5.1.3 Particle Concentration
Number of individual particles per unit volume of air.
5.1.4 Particle Size Distribution
Cumulative distribution of particle concentration as a function of particle
size.
5.2 OCCUPANCY STATES

8. 5.2.1 As-Built
Conditions where the installation is complete with all services
connected and functioning but with no production equipment,
materials, or personnel present.
4.2.1 At-Rest
Condition where the installation is complete with equipment
installed and operating, but with no personnel present.
6.0 CLASSICATION
6.1 Classification for Cleanliness Classes for Clean Rooms and Clean Zones
ISO Classification Number Particles / M3
0.5µm 5.0µm
ISO CLASS 5 3520 29
ISO CLASS 6 35200 293
ISO CLASS 7 352000 2930
ISO CLASS 8 3520000 29300
7.0 SAMPLING
7.1 ESTABLISHMENT OF SAMPLING LOCATION
7.1.1 Calculation for No. of Locations
To calculate the minimum number of sampling point locations:
NL = √A
Where,
NL is the minimum number of sampling locations ( rounded up
to a whole number
A is the area of clean room or clean zone in square meters
7.1.2 Sampling Point
Ensure that the sampling locations are evenly distributed
throughout the area of the clean room and positioned at a working
level.
7.2. ESTABLISHMENT OF SINGLE SAMPLE VOLUME PER
LOCATION

9. 7.2.1 Sampling Volume
At each sampling location, sampling a sufficient volume of air that
a minimum of 20 particles would be detected if the particle
concentration for the largest considered particles sized were at the
class limit for the designed ISO Class.
The single sample volume VS per locations is :
Vs =20/Cnm x 1000
Where,
Vs is the minimum single sample volume per location in liters
Cnm is the class limit ( number of particles per cubic meter ) for
the largest considered particles size specified for the
relevant class.
20 is the defined number of particle that could be counted if
the particle concentration were at the class limit.
8.0 PROCEDURE
8.1 Before starting the work take the details of the whole are that to be
validate.
8.2 Ask Engineering / maintenance person to arrange single phase power
supply.
8.3 Clean all the instruments with IPA before entering the clean area.
8.4 Ensure that the floor and area as well as Equipment is visually cleaned.
8.5 System should be kept ON 2 hours before starting the measurements.
8.6 Connect the Spike Guard to particle counter before starting the counter.
8.7 Set the Particle counter as per the given details of rooms/LAFs.
8.8 The sampling probe shall be positioned vertically upward.
8.9 Switch ON the Air Borne Particle Counter.

10. 8.10 Set the Particle Counter for 0 Purging before starting the measurement
8.11 Place the probe at working level height.
8.12 Start taking samples at different location as per the details and take print
of the reading.
8.13 The Thermal paper reading should be pasted on a blank page and should
be Xeroxed immediately.
9.0 REFERENCE
ISO 14644
10.0 ABBREVIATION
SOP Standard Operating Procedure
ISO International Standard Operating
LAF Laminar Air Flow Unit
AHU Air Handling Unit