Clean Room Validation Protocol PDF

FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp.
Hotel Pratik, Tembhode Road, Palghar PIN 401210 Dist : Thane
Performance Qualification Protocol
Doc. No.: AR/P/HVAC/01
CLEAN ROOM
Issue No.: 01
01.0
Revision No.: 00
Page 1 of 35
Effective Date: 31/10/2008
INDEX
Sr. No.
Content
Page No.
01.0
Index
02.0
Pre-Approval Sheet
03.0
Objective
04.0
Scope
05.0
Responsibilities
06.0
Introduction
07.0
Equipment And Material
08.0
Air Velocity Test And Calculation Of Air Changes Per Hour
09.0
HEPA Filter Integrity Testing
10.0
Air Flow Pattern Test
13
11.0
Non Viable Particulate Count Test
14
12.0
Recovery Study
18
13.0
Differential Pressure Test
19
14.0
Temperature Control Test
20
15.0
Humidity Control Test
21
16.0
Light Intensity Measurement: (Lux Measurement)
22
17.0
Noise Level Measurement
23
18.0
General Requirments
24
19.0
Annexure
25
20.0
Reference
35
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp. Hotel Pratik, Tembhode Road, Palghar PIN 401210 Dist : Thane

CLEAN ROOM
Issue No.: 01
Revision No.: 00

Page 2 of 35
2.0 PRE-APPROVAL SHEET:

Signing of this approval page of Performance Qualification protocol no. AR/P/HVAC/01
indicates agreement with the performance qualification approach described in this document.
Shall modifications to the performance qualification become necessary, on addendum will be
prepared and approved.
PREPARED BY
SIGNATURE
DATE
CHECKED BY
SIGNATURE
DATE
APPOVED BY
SIGNATURE
DATE
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head

CLEAN ROOM
Issue No.: 01
Revision No.: 00

Page 3 of 35
3.0 OBJECTIVE:
To establish that the documented evidence of HVAC System is meeting predetermined
specifications performing,
Air velocity (ACPH) measurement
HEPA Filter leak testing (using Hot or Cold DOP)
Air flow pattern test (Smoke test)
Nonviable particulate counts measurement
Recovery test
Monitoring of Differential pressure of the area
Monitoring of Temperature within the area
Monitoring of relative humidity within the area
Area light level measurement (LUX measurement)
Area noise level measurement (dB level)
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 4 of 35
Revision No.: 00
4.0 SCOPE:
The scopes of this study will verify that the HVAC System is effective & reproducible.
FREQUENCY: To be performed once in six months basis except Temperature, Relative
Humidity and Differential pressure, monitoring on daily basis.
5.0 RESPONSIBILITIES:
A team comprising of the representatives of the following functions shall be responsible to
undertake the qualification studies.
DESIGNATION
Validation Head
Validation Incharge
EDP Staff
RESPONSIBILITY
Responsible for final review and approval of protocol and
report
Responsible for perform site work within the time bond
period.
Responsible for Prepare Report.
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head

CLEAN ROOM
Issue No.: 01
Revision No.: 00

Page 5 of 35
6.0 INTRODUCTION:
The Heating, ventilation & air conditioning system installed at service floor of any company, It
consists of following AHU's & configuration of filters
SR.
NO.
AIR
HANDLING
HEPA
ROOM NAME
FILTERS
CLASS
UNITS
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head

CLEAN ROOM
Issue No.: 01

Page 6 of 35
Revision No.: 00
7.0 EQUIPMENT AND MATERIAL:
TSI Hot wire Anemometer / TSI air capture hood
Photometer with Aerosol generator
Fog generator (Smoke generator)
Airborne Non viable Particle counter
Calibrated Temperature & Relative Humidity data logger
Light level meter-Lux meter
Noise level meter-dBA meter
8.0
8.1
8.2
8.3
AIR VELOCITY TEST AND CALCULATION OF AIR CHANGES PER HOUR:

OBJECTIVE: To demonstrate that the required air velocity is delivered by HEPA
Filters and to calculate the Air changes per hour for each area.
ACCEPTANCE CRITERIA:
CRITERIA
ACCEPTANCE
Air velocity and ACPH
As per design NLT + 20 %
PROCEDURE: [FOR HOT WIRE ANEMOMETER]

STEP
ACTION
Start
Switch on respective air-handling unit (AHU) of clean room.
Ensure that AHU is operational for the last 5 to 10 minutes.
Take the relevant details, like No of filters of area, filter size, room volume,
AHU No, design CMH/CFM and ACPH for each room.
Switch `ON the calibrated hot wire Anemometer. Check the Zero reading
on the display.
Hold the `velocity measurement-probe at the working height 6 inches

(approx.150 mm) below the face of HEPA filter in clean room.
Record air velocity at different points of HEPA filter i.e. Four corners and one
center [Terminal HEPA]. For HEPA filter list with AHU & room
Calculate the average velocity of each filter.

Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 7 of 35
Revision No.: 00
STEP
ACTION
Average air velocity at each point.
Record velocity. [Reference is made to Annexure-I].

End
8.4 CALCULATION OF AIR CHANGES PER HOUR

STEP
ACTION
Start
Measure the filter face area in square meter.
Calculate the actual volume of supplied air in each room as below.
Air flow discharge [m3/minute] = Air velocity of HEPA filter [m/s] Filter area
[m2] x 60.
Calculate the volume of the room in cubic meter, of which air changes are to
be calculated.
Calculate the no. of air changes as follows.
No. of ACPH = Airflow discharge in room 60(CMH) Room volume.
For filling and sealing area, ACPH should not be less than 300.
For all the Classified areas, ACPH should not be less than 20.
If the air changes in the area are not within the limit, trouble shoot the cause
and rectify.
10
Engineering and QA staff should investigate the reason for the deviation.
Engineering will take immediate action to rectify it.
11
Record the ACPH [Annexure-I].

End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
8.5
Page 8 of 35
Revision No.: 00
PROCEDURE: [BY CAPTURE HOOD]
STEP
ACTION
Start
Switch on respective air-handling unit (AHU) of clean room.
Ensure that AHU is operational for the last 5 to 10 minutes.
Take the relevant details, like No of filters of area, filter size, room volume, AHU
Take the mean velocity reading of each filter [cfm) by capture hood
Calculate CMH of room by sum of all filter cfm multiply into 60.
Calculate the ACPH of room i.e.
Record the ACPH [Annexure-I]. If done by capture Hood.

End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 9 of 35
Revision No.: 00
9.0 HEPA FILTER INTEGRITY TESTING:

9.1 OBJECTIVE: To demonstrate and validate the filter integrity leak monitoring of the HEPA
filters installed in different areas like.
9.2 ACCEPTANCE CRITERIA:
CRITERIA
HEPA Filter Integrity Test
With Using Aerosol
ACCEPTANCE
An unacceptable leak is a local reading
greater than 0.01%
9.3 PROCEDURE: (FOR GENERATION OF AEROSOL):

STEP
ACTION
Start
Check the Aerosol oil level in Aerosol generator.
Connect Compressed air / Nitrogen gas to aerosol generator & adjust

the pressure regulator to 20PSI.
Direct the outlet of the aerosol generator to return duct [riser] or fresh
air intake of AHU.
Start the aerosol generator by switching on the Compressed air /

Nitrogen gas to produce the upstream concentration required for leak
detection till photometer reads the Photometric concentration of 100%.
End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head

CLEAN ROOM
Issue No.: 01

Page 10 of 35
Revision No.: 00
9.4 CALIBRATION OF THE INSTRUMENT [PHOTOMETER]

STEP
ACTION
Start
Put the photometer selector switch on upstream mode.
Connect the tube of photometer to upstream port of HEPA filter.
Wait until the photometer displays 100% upstream concentration.
Remove the tube of photometer and close the upstream port of HEPA filter
and ensure fir zero leakage.
Put the photometer selector switch on down stream mode.
Wait until photometer display 0 [ZERO].

On any installation the sealing gasket should be considered as part of the
filter and this should be scanned separately from the filter pack.
Select the sample port; scan the filter pack and the gasket at a distance
of 50 to 100 mm.
For a filter to efficiency 0.001% the range selected should be 0.01%
and the alarm set for 0.001%, which is 10% of the full scale, which
assumes an efficiency of 99.99% against the challenge aerosol.
End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 11 of 35
Revision No.: 00
9.5 TESTING PROCEDURE [TERMINAL HEPA FILTER WITHOUT INDIVIDUAL UPSTREAM

PORT]
STEP
ACTION
Start
Ensure that before staring activity AHU is operational for 5 to 10 minutes.
Ensure that the air velocity, air balancing and flow adjustments are done
before proceeding to the Filter integrity testing of HEPA filters.
Check that a sampling point is provided and accessible immediately

upstream of the filter to be tested.
Start the compressed air / nitrogen gas to Aerosol generator to generate the
test aerosol at minimum 20 psi and monitor the pressure.
Direct the test aerosol to riser of room.
Ensure that it is possible to introduce test aerosol so that 100%

concentration can be detected at the upstream sampling point.
Place the aerosol generator in an accessible position, ideally near the riser,
and adjust the aerosol concentration to the specified density.
Prior to the generation of the aerosol place the photometer probe down
stream of the HEPA filter until the instrument has stabilized.
Put photometer selector switch on upstream mode.
10
Check the upstream concentration of Aerosol at port provided for

representative HEPA filter for each room ;Until photometer displays 100 %
upstream.
11
After getting the upstream conc. & put selector switch to clear position and
close upstream Aerosol port.
12
Put photometer selector switch on down stream mode.
13
Wait until photometer displays 0.
14
Measure the down stream concentration by holding the probe approx.1 inch
away from the face of filter.
15
The photometer has a sample flow rate of 1 cfm. Hold the probe at a
distance between 50 to 100 mm from the filter face and scan the filter and
perimeter by passing the probe in slightly overlapping strokes so that the
entire area of filter and sealing gasket is sampled. The probe traverse rate
should not exceed 10 feet per minute.
16
Observe the percentage of leakage directly on photometer
17
If any leakage observed through the sealing of filter tighten the filter nuts
and check again for any leakage.
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head

CLEAN ROOM
Issue No.: 01
Page 12 of 35
Revision No.: 00
STEP
ACTION
18
If any leakage is more than 0.01% of the upstream aerosol concentration

then repair it.
19
Repair the patches on filter s should not exceed maximum of 5% of the total
filter face area & maximum width / length of each patch should not be more
than 1.5 inches. Total no of patches should not exceed 5 number / filter.
20
If above mentioned limit exceeds then replace the filter & check the integrity
of the filter as per above procedure.
21
Record the result [Annexure-II].
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 13 of 35
Revision No.: 00
10.0 AIR FLOW PATTERN TEST

10.1 OBJECTIVE: To determine airflow pattern of terminal HEPA filters and laminar air flow
units.
10.3
CRITERIA
ACCEPTANCE
Air flow pattern of HEPA filter
Unidirectional
PROCEDURE:
STEP
ACTION
Start
Start the respective AHU of which airflow pattern is to be checked.
Person carrying out airflow pattern activity should follow clean room
gowning.
Fog generator should be used for smoke generation.
During the process, hands of operator and facemask should be

covered properly with gloves and facemask.
Expose the smoke at supply end of the system.
Observe the smoke pattern and ensure the following.

The airflow pattern should be within specification in order to ensure
environmental contamination control.
The smoke should be diffused uniformly at supply grill and pass
through return riser.
Carry out Videography/ Photography of the entire airflow pattern

checking activity.
Record the result [Annexure-III].
End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head

CLEAN ROOM
Issue No.: 01
Page 14 of 35
Revision No.: 00
11.0
NON VIABLE PARTICULATE COUNT TEST:
11.1
OBJECTIVE: To establish that zone meets predefined conditions for non-viable
particles.
11.2
ACCEPTANCE CRITERIA: As Per EU Guide
CRITERIA
ACCEPTANCE
Maximum number of permitted particles per cubic meter
equal to or above
Grade
Non viable
particulate
count test
AT REST
IN OPERATION
0.5-5m
>5 m
0.5-5m
>5 m
3500
3500
3500
350000
2000
350000
2000
3500000
20000
3500000
20000
Not defined
Not
defined
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 15 of 35
Revision No.: 00
11.3 PROCEDURE: ESTABLISHMENT OF SAMPLING LOCATION:

STEP
ACTION
Start
All components of the clean air system affecting air quality must be
operating in accordance with the specification and all aspects of the
controlled environment, which contribute to the operational integrity, are
complete.
Measure on a centered grid pattern determined by dividing the total floor
area, into approximately equal areas such that:
The number of sub-areas is as specified in any relevant national

standard or as agreed between the client and the contractor
sampling positions should be at the intersection of the corners of
each sub-area and at a height of 900 mm from the floor, unless
agreed otherwise by the client.
Take the required number of samples at the specified flow rate at

each point on the grid. These can be determined from the relevant
national standards or agreed by the customer.
Calculate the number of sampling locations with the formula
N = Square root of Room in cubic meter made it to approx. [Reference is

made to ISO14644-1].
The sampling location shall be evenly distributed throughout the area of
clean room or clean zone and position at the height of work activity. In
case of additional sampling locations their number and position will be
specified.
End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 16 of 35
Revision No.: 00
11.4 ESTABLISHMENT OF SINGLE SAMPLE VOLUME PER LOCATION:

STEP
ACTION
Start
Sample a sufficient volume of air at each location such that minimum of

20 particles would be detected if the particle concentration for the
relevant class were at the class limit for the largest considered particle
size.
The single sample volume Vs per location will be determined by
Vs =20x1000 / Cnm Where
Vs = is the minimum sample volume per location expressed in liters.
Cnm =class limit (number of particles/ m3) for the largest considered
particles size specified for the relevant class.
20 = is the defined number of particles that could be counted if particle

concentration were at the class limit.
The volume sampled at each location shall be at least 2 liters with a
minimum time at each location of 1 minute.
Since particle counter operate at a flow rate of 1CFM, which is equal to
28.3 lits per minute, therefore particle analyzed per cubic feet will need
to be multiply with 35.31 to convert to m3.
Direct measurement with 1 M3 particle counter,
Specification are: 50 LPM i.e. 1M3 i.e. 1000 liters per 20 minutes.
Sample at each location is taken for 20 minutes, which is equivalent to

50 LPM i.e. 1M3/20 minutes. There fore for grade A/B/C areas
[ISO/5/6/7] and for grade D area 1 minute per location. Sampling
locations are abased on the criticality of the work zone [Reference is
made to AnnexureIV].
End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 17 of 35
Revision No.: 00
11.5 SAMPLING AT SPECIFIED LOCATIONS AT WORKING HEIGHT:

STEP
ACTION
Start
Start the sampling and take minimum of single sample volumes from
each location and compute the average particle concentration at
specified location.
Sampling will be conducted at rest and during operation.

End
11.6 PARTICLE COUNTING AT EACH LOCATION

STEP
ACTION
Start
Switch on the AHU and let it run for 10-15 minutes.
Switch `ON the particle counter and set the sampling rate as 1.0 cfm
(Approximately 28.0 liters/minute).
Hold the particle counter probe to the working height at different

locations of control/critical areas and take the print out of the particle
counts of mentioned locations of control/critical areas.
Take the particle count at different location under HEPA filters covering
total area of the control / critical room as mentioned in layout & take
printouts of particle count.
Switch OFF the particle counter.
Get report of the particle count by the external party (Supplier)
Such reports should be preserved by the Quality Assurance department.
Particle count test of all control /critical rooms under AHUs to be carried
out once in six months or earlier immediately after any major change in
AHU facility.
10
Record the results and make the trend of particle count [Reference is
made to Annexure IV].
End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
12.0
Page 18 of 35
Revision No.: 00
RECOVERY STUDY
12.1 OBJECTIVE: To determine the recovery period for the HEPA filters installed in critical
areas.
CRITERIA
ACCEPTANCE
Not more than 10 minutes/As per
Design Specification
Recovery period
12.3 PROCEDURE:
STEP
ACTION
Start
Measure the clean room or clean zone non-viable particulate counts at

rest [before disturbing the area for Recovery test].
Shut OFF the AHU of required zone.
Allow the required zone to reach next higher grade (i.e. Grade B To
Grade C).
Measure the non-viable particulate counts when area achieve the next
higher grade with help of particle counter for one day.
Continue the particle counting for at least 5 counts.
Start the AHU and measure the particle counts till it the area achieves
the desired level of counts approximately equivalent to the initial counts
taken at rest before the test.
Measure time taken to recovery the initial grade.
Record the results and enclose the particle count printouts and calculate
the recovery time as-
5 minutes-Initial count after AHU shut OFF
X minutes-Time taken by the area to recover to initial counts after

getting the next grade.
Recovery time = X minutes.
Record the result [Reference is made to Annexure-V].

End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head

CLEAN ROOM
Issue No.: 01
13.0

Page 19 of 35
Revision No.: 00
DIFFERENTIAL PRESSURE TEST
13.1 OBJECTIVE: To demonstrate the capability of the air system to provide pressure
gradient among the different room.
13.2
CRITERIA
Differential pressure of rooms
ACCEPTANCE
As per design sheet + 0.5 mm of water
13.3 PROCEDURE:
STEP
ACTION
Start
All HVAC systems of the clean room facility are to be in continuous

operation when performing these tests.
To avoid unexpected changes in pressure and to establish baseline, all

doors in sterile facility must be closed and no traffic is to be allowed through
the facility during the test.
Adjust the Magnehelic gauge to give a reading of zero in accordance with

the manufacturers instructions.
Connect one end of the tubes to the higher-pressure side of the Magnehelic
gauge(Calibrated) & place the other end of the tube in the area of higher
pressure such that it is free from obstruction and directed away from any
airflows.
Next, connect one end of the second tube to the lower pressure input side
of the Magnehelic gauge and place the other end of the tube in the area of
lower pressure such that it is free from obstruction and directed away from
any airflows. If the tubing passes a surface ensure that any gap surrounding
the tube are sealed.
Record the pressure displayed on the Magnehelic gauge three times ,for
design differential pressure.
Record the result [Reference is made to Annexure-VII].

End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
14.0
Page 20 of 35
Revision No.: 00
TEMPERATURE CONTROL TEST
14.1 OBJECTIVE: To demonstrate the ability of the AHU's to provide the required
temperature in critical and controlled areas.
14.2
CRITERIA
Temperature of controlled areas
14.3
ACCEPTANCE
NMT 25 0C
PROCEDURE
STEP
ACTION
Start
Verify that the air conditioning system is operating in the stable condition
and all equipment that is specified is running.
Divide the room area in four equal zones test as required by the
specification or on a grid pattern of 3m x 3m.
Use calibrated Data logger to record the temperature.
Record the temperature for location in each room .
Record the result [Reference is made to Annexure-VI].

End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
15.0
Page 21 of 35
Revision No.: 00
HUMIDITY CONTROL TEST
15.1 OBJECTIVE: To demonstrate the capability of air handling system to control relative
humidity at the specified level in each room in critical area and controlled areas.
15.2
CRITERIA
ACCEPTANCE
Relative humidity in critical area
NMT 50 %
Relative humidity in controlled area
NMT 55%
15.3 PROCEDURE:
STEP
ACTION
Start
Execute humidity control test after all the air balancing procedure have been
concluded and air conditioning system is completely in operation and stable
conditions have been achieved
Use calibrated Data Logger to record the relative humidity.
Record the relative humidity in room as per layout of relative humidity record in
each room.
Record the result for three consecutive days [Reference is made to Annexure-VI].
End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
16.0
Page 22 of 35
Revision No.: 00
LIGHT INTENSITY MEASUREMENT: LUX MEASUREMENT
16.1 OBJECTIVE: To determine the lighting level and its uniformity throughout an area at predetermined points
16.2
ACCEPTANCE
CRITERIA
Light level
16.3
Not less than 300 lux / As per Design Specification
PROCEDURE
STEP
ACTION
Start
Record the light levels on a pre-determined grid pattern/ layout of lux

level or in the absence of a specification on a 3m x 3m grid pattern.
Divide the room into four equal locations.
Record the light level at working height or 750 mm above finished floor
height.
The area under test must have all fitted lights working and the area
structure should be complete also if required emergency lighting levels
can be recorded.
Record the light levels in lux for each position on the grid [Reference is
made to AnnexureVII].
Note down all variations from the specification if any.

End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 23 of 35
Revision No.: 00
17.0
NOISE LEVEL MEASUREMENT:
17.1
OBJECTIVE: To determine the noise level and its uniformity throughout an area
at pre-determined points.
17.2
CRITERIA
ACCEPTANCE
Noise level
Not more than 85 dB / As per Design Secification
17.3 PROCEDURE
STEP
ACTION
Start
Verify that the air conditioning system is operating in the stable condition
and all equipment that is specified is running [In operational condition].
Map out the area under test as required by the specification in a 2400 mm
x 2400 mm x grid or on a previously agreed location basis i.e divide the
area into fur equal parts.
Set the instrumentation to work and ensure unauthorized entry and exits
from the room are prevented.
Measure the sound levels at work surface height or 750 mm from the
finished floor level and layout of noise level.
Record the data [Reference is made to Annexure- VII].
Note down all variations from the specification if any.

End
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Revision No.: 00
Page 24 of 35
18.0 GENERAL REQUIRMENTS:

18.1 The protocol should be signed off (prior to start validation activities).
18.2 Under responsibility of the Validation Head, Performance Qualification will be executed.
18.3 After execution of required tests, the Validation Head should
Check the results versus the Acceptance Criteria.
Write the report.
18.4 The report will be approved by the same persons (or same designations) who has
Undersigned the protocol.
18.5 The report should contain the following information:
Report of all measurements and/or analytical results
List of all documentation and or certifications.
Check of the results against the Acceptance Criteria.
Conclusions concerning this validation study
Name and designations of persons who has executed the protocol
Any (relevant) deviation from the prescriptions in this protocol and the
Justification for the deviation.
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head

CLEAN ROOM
Issue No.: 01
19.0
Page 25 of 35
Revision No.: 00
ANNEXURE
ANNEXURE I (Air Velocity & ACPH Calculation)
Ambient Condition:- NMT 25 & 50-55%RH

:
:
:
:
:
:
Area/Room Name
Department
Code No.
AHU No.
Test
Equipment Used
Air Velocity & ACPH Calculation
Test Performed Date

Test End Date
Next Due Date
Acceptance Criteria
Occupancy State
Test Method
:
:
:
: 20%
: At rest/ At operation
:
Observation Table:
Sr.
No.
Filter
Tag No.
Obs. Rdg.
(m/s)/(ft/min)
1
Avg.
Velocity
CMM/
CFM
Total
CMM/ CFM
Room
Volume
Graphical Representation: Filters v/s CMH & Filters v/s ACPH

Filters v/s CMH
Filters v/s ACPH
Conclusion:
Certified As Per ISO 14644
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
ACPH
CLEAN ROOM
Issue No.: 01
Page 26 of 35
Revision No.: 00
ANNEXURE II (Filter Integrity test (DOP/PAO)

Area/Room Name
Department
Code No.
AHU No.
:
:
:
Test
Equipment Used
:
:
:
Filter Integrity test (DOP/PAO)
Test Performed Date

Test End Date
Next Due Date
Acceptance Criteria
:
:
:
Occupancy State
Test Method
:
:
0.01% As Per ISO

14644
At rest/ At operation
Observation Table:
Sr.
No.
Filter Tag
No.
Concentration
----
----
Upstream
Conc. %
Leak in %
DOP/ PAO
Test Result
Remark
Graphical Representation: Filters v/s Leak in %
Conclusion:
Certified As Per ISO 14644
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head

CLEAN ROOM
Issue No.: 01
Page 27 of 35
Revision No.: 00
ANNEXURE III (Air Flow Visualization)

Area/Room Name
Department
Code No.
AHU No.
Test
Equipment Used
:
:
:
:
:
:
Test Performed Date
Air Flow Visualization
Test End Date

Next Due Date
Test Method
Occupancy State
:
:
:
:
:
Trace Injection Air Flows Visualization
Observation Table:
Sr. No.
Filter Tag No.
Flow Pattern Observed
Remark
Photographic Representation:
Conclusion:
Certified As Per Design Qualification.
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 28 of 35
Revision No.: 00
ANNEXURE IV (Non Viable Particle Count Measurement)

Area/Room Name
Department
Code No.
AHU No.
Test
Equipment Used
:
:
:
:
:
:
Non Viable Particle Count. Meas.
Test Performed Date

Test End Date
Next Due Date
For Class
Occupancy State
Test Method
:
:
:
:
:
:
Observation Table:
Location
No.
Occupancy
State
1
2
At rest
At operation
No. of Particles Per CFM/CMM

0.5
5
Remark
Conclusion:
Meets/ Does not meets the acceptance Criteria as per ISO 14644/USFDA/USP/EU/GMP.
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Revision No.: 00
Page 29 of 35
ANNEXURE V (Recovery)
Area/Room Name
Department
Code No.
AHU No.
Test
Equipment Used
:
:
:
:
:
:
Test Performed Date

Test End Date
Next Due Date
Acceptance Criteria
Recovery
Occupancy State
Test Method
:
:
:
:
:
:
At rest
Observation Table:- For Class

Location
AHU
STATUS
Time
Required
No. of Partical Per CFM/CMM

0.5m
5m
Remark
Conclusion:
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Revision No.: 00
Page 30 of 35
ANNEXURE VI (Temp. & RH Mapping)

Area/Room Name
Department
Code No.
AHU No.
Test
Equipment Used
Occupancy State
:
:
:
:
:
:
:
Test Performed Date

Mapping Duration
Frequency of Rdg.
Acceptance Criteria
Next Due Date
No. of Channel
Temp. & RH Mapping
:
:
:
:
:
:
Schematic Diagram:
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 31 of 35
Revision No.: 00
Mapping Observations Table:

Time
P1
Temp
P2
RH
Temp
RH
Positions
P3
Temp
RH
P4
Temp
P5
RH
Temp
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
RH

CLEAN ROOM
Issue No.: 01
Revision No.: 00

Page 32 of 35
Graphical Representation: [Temperature ( C) v/s Time]
Graphical Representation: [Relative Humidity (% RH) v/s Time]
Conclusion:
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 33 of 35
Revision No.: 00
ANNEXURE VII (Differential Pressure & Lux Level Measurement)

Area/Room Name
Department
Code No.
AHU No.
Test
Equipment Used
:
:
:
:
:
:
Test Performed Date

Test End Date
Next Due Date
Acceptance Criteria
Test Method
Occupancy State
:
:
:
:
:
:
Observation Table: (For Differential Pressure)

Designed Press.
mm of of H2O
Actual Press. (mm of H2O)

1
mm of H2O
Average
Remark
Average
(Lux)
Remark
Conclusion:
Observation Table: (For Lux Level)
Designed
(Lux)
Actual (Lux)
1
Conclusion:
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 34 of 35
Revision No.: 00
ANNEXURE VIII (Sound Level (dB))

Observation Table: (For Sound Level)
Design (dB)
Actual (dB)
2
Average (dB)
Remark
Conclusion:
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head
CLEAN ROOM
Issue No.: 01
Page 35 of 35
Revision No.: 00
20.0 REFERENCE:NO.
CODE
TITLE
ISO 14644
Clean Room & Associated Environment
VMP-2006
Validation Master Plan.
SCH.M Pt. I-A
Drug and Cosmetics act 1940.
Annex 6
WHO Technical report series No 902, 2002.
USP
2005 USP NF the Official compendia of standards.
EC GUIDE
EC guide to good manufacturing practice annexure-1 September 2003.
Prepared by:
Approved by:
Issued by:
Validation Incharge
Validation Head
Validation Head

Clean Room Validation Protocol PDF

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Clean Room Validation Protocol PDF

Uploaded by

Copyright:

Available Formats

FLAT No. A/1, Shrusthi Shobha Co-op Hsg Society Opp.

Hotel Pratik, Tembhode Road, Palghar PIN 401210 Dist : Thane

Performance Qualification Protocol

Doc. No.: AR/P/HVAC/01

Equipment And Material

Air Velocity Test And Calculation Of Air Changes Per Hour

HEPA Filter Integrity Testing

Air Flow Pattern Test

Non Viable Particulate Count Test

Differential Pressure Test

Temperature Control Test

Humidity Control Test

Light Intensity Measurement: (Lux Measurement)

Noise Level Measurement

Performance Qualification Protocol

Doc. No.: AR/P/HVAC/01

2.0 PRE-APPROVAL SHEET:

Performance Qualification Protocol

Doc. No.: AR/P/HVAC/01

Air velocity (ACPH) measurement

HEPA Filter leak testing (using Hot or Cold DOP)

Air flow pattern test (Smoke test)

Nonviable particulate counts measurement

Monitoring of Differential pressure of the area

Monitoring of Temperature within the area

Monitoring of relative humidity within the area

Area light level measurement (LUX measurement)

Area noise level measurement (dB level)

Performance Qualification Protocol

Doc. No.: AR/P/HVAC/01

Effective Date: 31/10/2008

Performance Qualification Protocol

Doc. No.: AR/P/HVAC/01

Performance Qualification Protocol

Doc. No.: AR/P/HVAC/01

Effective Date: 31/10/2008

7.0 EQUIPMENT AND MATERIAL:

TSI Hot wire Anemometer / TSI air capture hood

Photometer with Aerosol generator

Fog generator (Smoke generator)

Airborne Non viable Particle counter

Calibrated Temperature & Relative Humidity data logger

Light level meter-Lux meter

Noise level meter-dBA meter

AIR VELOCITY TEST AND CALCULATION OF AIR CHANGES PER HOUR:

Air velocity and ACPH

As per design NLT + 20 %

PROCEDURE: [FOR HOT WIRE ANEMOMETER]

Switch on respective air-handling unit (AHU) of clean room.

Ensure that AHU is operational for the last 5 to 10 minutes.

Hold the `velocity measurement-probe at the working height 6 inches

Calculate the average velocity of each filter.

Performance Qualification Protocol

Doc. No.: AR/P/HVAC/01

Effective Date: 31/10/2008

Average air velocity at each point.

Record velocity. [Reference is made to Annexure-I].

8.4 CALCULATION OF AIR CHANGES PER HOUR

Measure the filter face area in square meter.

Calculate the actual volume of supplied air in each room as below.

Calculate the no. of air changes as follows.

No. of ACPH = Airflow discharge in room 60(CMH) Room volume.

Record the ACPH [Annexure-I].