Performance Qualification

Performance
Qualification Protocol
Doc. No.: AR/P/HVAC/01
CLEAN ROOM
Page 1 of
35Issue No.: 01 Revision No.:
00 Effective Date: 31/10/2008P
repared by: Approved by: Iss
ued by:Validation Incharge Va
lidation Head Validation Head
01.0
INDEXSr. No. Content Page
No.
01.0 Index 102.0 Pre-
Approval Sheet 203.0 Objecti
ve 304.0 Scope 405.0 Respo
nsibilities 406.0 Introduction 5
07.0 Equipment And Material
608.0 Air Velocity Test And C
alculation Of Air Changes Per
Hour 609.0 HEPA Filter Integ
rity Testing 910.0 Air Flow Pa
ttern Test 1311.0 Non Viable
Particulate Count Test 1412.0
Recovery Study 1813.0 Diffe
rential Pressure Test 1914.0
Temperature Control Test 20
15.0 Humidity Control Test 21
16.0 Light Intensity Measure
ment: (Lux Measurement) 22
17.0 Noise Level Measureme
nt 2318.0 General Requirmen
ts 2419.0 Annexure 2520.0 R
eference 35
 Highlight
 Add Note
 Share Quote
FLAT No. A/1, Shrusthi Shobha Co-op Hsg
Society Opp. Hotel Pratik, Tembhode Road,
Palghar
PIN – 401210 Dist : Thane
Performance
CLEAN ROOM
Page 2 of
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
beprepared and approved.
PREPARED BY SIGNATUR
E DATECHECKED BY SIGN
ATURE DATEAPPOVED BY
SIGNATURE DATE
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Page 3 of
3.0 OBJECTIVE:
To establish that the
documented evidence of
HVAC System is meeting
predeterminedspecifications
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)
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Page 4 of
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,
RelativeHumidity and
Differential pressure,
monitoring on daily basis.
5.0 RESPONSIBILITIES:
A team comprising of the
representatives of the
following functions shall be
responsible toundertake the
qualification studies.
DESIGNATION
RESPONSIBILITY
Validation HeadResponsible
for final review and approval
of protocol
andreportValidation
InchargeResponsible for
perform site work within the
time
bondperiod.EDP Staff Respo
nsible for Prepare Report.
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Page 5 of
6.0 INTRODUCTION:
The Heating, ventilation & air
conditioning system installed
at service floor of any
company, Itconsists of
following AHU's &
configuration of filters
SR.NO.AIRHANDLINGUNIT
SROOM
NAMEHEPAFILTERSCLAS
S
Palghar
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Page 6 of
7.0 EQUIPMENT
AND MATERIAL:
•
TSI Hot wire Anemometer /

TSI air capture hood
•
Photometer with Aerosol gen
erator
•
Fog generator (Smoke gener

ator)
•
Airborne Non viable Particle

counter
•
Calibrated Temperature &

Relative Humidity data logger
•
Light level meter-Lux meter
•
Noise level meter-dBA meter

8.0 AIR VELOCITY TEST
AND CALCULATION OF
AIR CHANGES PER HOU
R:8
.1
OBJECTIVE:
To demonstrate that the

required air velocity is
delivered by HEPAFilters and
to calculate the Air changes
per hour for each area.
8
.2
ACCEPTANCE CRITERIA:
CRITERIA
ACCEPTANCE
Air velocity and ACPH As per

design NLT + 20 %
8
.3
PROCEDURE: [FOR
HOT WIRE ANEMOMETER]
STEP ACTIONStart
1Switch on respective air-
handling unit (AHU) of clean
room.2Ensure that AHU is
operational for the last 5 to 10
minutes.3Take the relevant
details, like No of filters of
area, filter size, room
volume,AHU No, design
CMH/CFM and ACPH for
each room.4Switch `ON’ the
calibrated hot wire
Anemometer. Check the
“Zero” readingon the
display.5Hold the `velocity
measurement’-probe at the
working height 6
inches(approx.150 mm)
below the face of HEPA filter
in clean room.6Record air
velocity at different points of
HEPA filter i.e. Four corners
and onecenter [Terminal
HEPA]. For HEPA filter list
with AHU & room7Calculate
the average velocity of each
filter.
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Page 7 of
STEP ACTION
8Average air velocity at each
point.9Record velocity.
[Reference is made to
Annexure-I]
.
End8.4 CALCULATION OF
AIR CHANGES PER
HOURSTEP ACTIONStart
1 Measure the filter face area
in square meter.2 Calculate t
he actual volume of supplied
air in each room as below.3Ai
r flow discharge [m
3
/minute] = Air velocity of
HEPA filter [m/s]
×
Filter area[m
2
]x
60.4 Calculate the volume of t
he room in cubic meter, of wh
ich air changes are tobe
calculated.5 Calculate the no.
of air changes as follows.6N
o. of ACPH = Airflow
discharge in room
×
60(CMH)
÷
Room
volume.7 For filling and sealin
g area, ACPH should not be l
ess than 300.8 For all the Cla
ssified areas, ACPH should n
ot be less than 20.9 If the air
changes in the area are not w
ithin the limit, trouble shoot th
e causeand
rectify.10 Engineering and Q
A staff should investigate the
reason for the deviation.Engin
eering will take immediate
action to rectify it.11Record
the ACPH
[Annexure-I]
.
End
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Page 8 of
8.5 PROCEDURE:
[BY CAPTURE HOOD]
STEP ACTIONStart
1Switch on respective air-
handling unit (AHU) of clean
room.2Ensure that AHU is
operational for the last 5 to 10
minutes.3Take the relevant
details, like No of filters of
area, filter size, room volume,
AHU4Take the mean velocity
reading of each filter [cfm) by
capture hood5Calculate CMH
of room by sum of all filter cfm
multiply into 60.7Calculate
the ACPH of room
i.e.8Record the ACPH
[Annexure-I]. If done by
capture Hood.
End
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Page 9 of
9.0 HEPA FILTER
INTEGRITY TESTING:
9.1 OBJECTIVE:
To demonstrate and validate

the filter integrity –leak
monitoring of the HEPAfilters
installed in different areas
like.
9.2 ACCEPTANCE CRITERI

A:
CRITERIA
ACCEPTANCE
HEPA Filter Integrity TestWith
Using AerosolAn
unacceptable leak is a local
readinggreater than 0.01%
9.3 PROCEDURE: (FOR GE
NERATION OF AEROSOL):
STEP ACTIONStart
1Check the Aerosol oil level
in Aerosol
generator.2Connect
Compressed air / Nitrogen
gas to aerosol generator &
adjustthe pressure regulator
to 20PSI.3Direct the outlet of
the aerosol generator to
return duct [riser] or freshair
intake of AHU.4Start the
aerosol generator by
switching on the Compressed
air /Nitrogen gas to produce
the upstream concentration
required for leakdetection till
photometer reads the
Photometric concentration of
100%.
End
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Page 10 of
9.4 CALIBRATION OF THE
INSTRUMENT
[PHOTOMETER]STEP
ACTIONStart
1Put the photometer selector
switch on upstream
mode.2Connect the tube of
photometer to upstream port
of HEPA filter.3Wait until the
photometer displays 100%
upstream
concentration.4Remove the
tube of photometer and close
the upstream port of
HEPA filterand ensure fir zero
leakage.5Put the photometer
selector switch on down
stream mode.6Wait until
photometer display 0
[ZERO].On any installation
the sealing gasket should be
considered as part of thefilter
and this should be scanned
separately from the filter
pack.
•
Select the sample
port; scan the filter
pack and the gasket
at a distanceof 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,
whichassumes an efficiency
of 99.99% against the
challenge aerosol.
End

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Page 11 of
9.5 TESTING PROCEDURE
[TERMINAL HEPA FILTER
WITHOUT INDIVIDUAL
UPSTREAMPORT]STEP
ACTIONStart
1 Ensure that before staring a
ctivity AHU is operational for
5 to 10 minutes.2 Ensure that
the air velocity, air balancing
and flow adjustments are don
ebefore proceeding to the
Filter integrity testing of HEPA
filters.3 Check that a samplin
g point is provided and acces
sible immediatelyupstream of
the filter to be
tested.4 Start the compresse
d air / nitrogen gas to Aerosol
generator to generate thetest
aerosol at minimum 20 psi
and monitor the
pressure.5 Direct the test aer
osol to riser of room.6 Ensur
e that it is possible to introduc
e test aerosol so that 100%co
ncentration can be detected
at the upstream sampling
point.7Place the aerosol
generator in an accessible
position, ideally near the
riser,and adjust the aerosol
concentration to the specified
density.8Prior to the
generation of the aerosol
place the photometer probe
downstream of the HEPA
filter until the instrument has
stabilized.9Put photometer
selector switch on upstream
mode.10Check the upstream
concentration of Aerosol at
port provided
forrepresentative HEPA filter
for each room;Until
photometer displays 100
%upstream.11After getting
the upstream conc. & put
selector switch to clear
position andclose upstream
Aerosol
port.12 Put photometer select
or switch on down stream mo
de.13Wait until photometer
displays 0.14Measure the
down stream concentration
by holding the probe approx.1
inchaway from the face of
filter.15The photometer has a
sample flow rate of 1 cfm.
Hold the probe at adistance
between 50 to 100 mm from
the filter face and scan the
filter andperimeter by passing
the probe in slightly
overlapping strokes so that
theentire area of filter and
sealing gasket is sampled.
The probe traverse
rateshould not exceed 10 feet
per minute.16Observe the
percentage of leakage
directly on photometer
17If any leakage observed

through the sealing of filter
tighten the filter nutsand
check again for any leakage.
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Page 12 of
STEP ACTION
18If any leakage is more than
0.01% of the upstream
aerosol concentrationthen
repair it.19Repair the patches
on filter s should not exceed
maximum of 5% of the
totalfilter face area &
maximum width / length of
each patch should not be
morethan 1.5 inches. Total no
of patches should not exceed
5 number / filter.20If above
mentioned limit exceeds then
replace the filter & check the
integrityof the filter as per
above
procedure.21 Record the res
ult [Annexure-II].
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Page 13 of
10.0 AIR FLOW
PATTERN TEST
10.1 OBJECTIVE:
To determine airflow pattern
of terminal HEPA filters and
laminar air flowunits.
10.2 ACCEPTANCE
CRITERIA:
CRITERIA
ACCEPTANCE
Air flow pattern of HEPA filte
r Unidirectional
10.3 PROCEDURE:
STEP ACTIONStart
1Start the respective AHU of
which airflow pattern is to be
checked.2Person carrying out
airflow pattern activity should
follow clean
roomgowning.3Fog generator
should be used for smoke
generation.4During the
process, hands of operator
and facemask should
becovered properly with
gloves and
facemask.5Expose the
smoke at supply end of the
system.6Observe the smoke
pattern and ensure the
following.
•
The airflow
pattern should be within speci
fication in order to ensureenvi
ronmental contamination
control.
•
The smoke should be diffuse
d uniformly at supply grill
and passthrough return
riser.7Carry out Videography/
Photography of the entire
airflow patternchecking
activity.8 Record the result [A
nnexure-III
]
.9
End

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Page 14 of
11.0 NON VIABLE PARTICU
LATE COUNT TEST:
11.1 OBJECTIVE:
To establish that zone meets
predefined conditions for non-
viableparticles.
11.2 ACCEPTANCE CRITER

IA:
As Per EU Guide
CRITERIA ACCEPTANCE
Maximum number of
permitted particles per cubic
meterequal to or above
AT REST IN OPERATION
Grade0.5-5µm >5 µm 0.5-
5µm >5 µmA 3500 0 3500 0B
3500 0 350000 2000C 35000
0 2000 3500000 20000Non
viableparticulatecount
testD 3500000 20000 Not defi
nedNotdefined
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Page 15 of
11.3 PROCEDURE:
ESTABLISHMENT OF
SAMPLING
LOCATION:STEP
ACTIONStart
1 All components of the clean
air system affecting air qualit
y must beoperating in
accordance with the
specification and all aspects
of thecontrolled environment,
which contribute to the
operational integrity,
arecomplete.
2 Measure on a centered grid

pattern determined by dividin
g the total floorarea, into
approximately equal areas
such that:
•
The number of sub-areas is

as specified in any relevant
nationalstandard or as agreed
between the client and the
contractorsampling positions
should be at the intersection
of the corners ofeach sub-
area and at a height of 900
mm from the floor,
unlessagreed otherwise by
the client.
•
Take the required number of
samples at the specified flow
rate ateach point on the grid.
These can be determined
from the relevantnational
standards or agreed by the
customer.3 Calculate the num
ber of sampling locations with
the formulaN = Square root
of Room in cubic meter made
it to approx. [Reference
ismade to
ISO14644-1
].4 The sampling location shal
l be evenly distributed throug
hout the area ofclean room or
clean zone and position at the
height of work activity. Incase
of additional sampling
locations their number and
position will bespecified.
End
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Page 16 of
11.4 ESTABLISHMENT OF
SINGLE SAMPLE VOLUME
PER LOCATION:STEP
ACTIONStart
1Sample a sufficient volume
of air at each location such
that minimum of20 particles
would be detected if the
particle concentration for
therelevant class were at the
class limit for the largest
considered particlesize.2The
single sample volume V
s
per location will be
determined byV
s
=20x1000 / C
nm
WhereV
s
= is the minimum sample
volume per location
expressed in liters.C
nm
=class limit (number of
particles/ m
3
) for the largest
consideredparticles size
specified for the relevant
class.20 = is the defined
number of particles that could
be counted if
particleconcentration were at
the class limit.The volume
sampled at each location
shall be at least 2 liters with
aminimum time at each
location of 1 minute.
Since particle counter operate
at a flow rate of 1CFM, which
is equal to28.3 lits per minute,
therefore particle analyzed
per cubic feet will needto be
multiply with 35.31 to convert
to m
3
.3Direct measurement with 1
M
3
particle counter,Specification
are: 50 LPM i.e. 1M
3
i.e. 1000 liters per 20
minutes.Sample at each
location is taken for 20
minutes, which is equivalent
to50 LPM i.e. 1M
3
/20 minutes. There fore for g
rade A/B/C areas[ISO/5/6/7]
and for grade D area 1
minute per location.
Samplinglocations are
abased on the criticality of the
work zone [Reference ismade
to
AnnexureIV
].
End

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Page 17 of
11.5 SAMPLING
AT SPECIFIED
LOCATIONS AT WORKING
HEIGHT:STEP ACTIONStart
1 Start the sampling and take
minimum of single sample vol
umes fromeach location and
compute the average particle
concentration atspecified
location.2 Sampling will be co
nducted at rest and during op
eration.
End11.6 PARTICLE
COUNTING AT EACH
LOCATIONSTEP
ACTIONStart
1Switch on the AHU and let it
run for 10-15 minutes.2Switch
`ON’ the particle counter and
set the sampling rate as 1.0
cfm(Approximately 28.0
liters/minute).3Hold the
particle counter probe to the
working height at
differentlocations of
control/critical areas and take
the print out of the
particlecounts of mentioned
locations of control/critical
areas.4Take the particle
count at different location
under HEPA filters
coveringtotal area of the
control / critical room as
mentioned in layout &
takeprintouts of particle
count.6Switch OFF the
particle counter.7Get report of
the particle count by the
external party
(Supplier)8Such reports
should be preserved by the
Quality Assurance
department.9Particle count
test of all control /critical
rooms under AHUs to be
carriedout once in six months
or earlier immediately after
any major change inAHU
facility.10Record the results
and make the trend of particle
count [Reference ismade to
Annexure IV
]
.
End
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Page 18 of
12.0 RECOVERY STUDY
12.1
OBJECTIVE
:
To determine the recovery

period for the HEPA filters
installed in criticalareas.
12.2
ACCEPTANCE CRITERIA:
CRITERIA
ACCEPTANCE
Recovery periodNot more
than 10 minutes/As
perDesign Specification
12.3
PROCEDURE:
STEP ACTIONStart
1Measure the clean room or
clean zone non-viable
particulate counts atrest
[before disturbing the area for
Recovery
test].2 Shut OFF the AHU of r
equired zone.3Allow the
required zone to reach next
higher grade (i.e. Grade B
ToGrade C).4Measure the
non-viable particulate counts
when area achieve the
nexthigher grade with help of
particle counter for one
day.5 Continue the particle co
unting for at least 5 counts.6S
tart the AHU and measure the
particle counts till it the area
achievesthe desired level of
counts approximately
equivalent to the initial
countstaken at rest before the
test.7 Measure time taken to r
ecovery the initial grade.8Rec
ord the results and enclose
the particle count printouts
and calculatethe recovery
time as-
•
5 minutes-
Initial count after AHU shut O
FF
•
X minutes-
Time taken by the area to rec
over to initial
counts aftergetting the next
grade.
•
Recovery time = X minutes.9
Record the result [Reference
is made to
Annexure-V
]
.
End

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Page 19 of
13.0 DIFFERENTIAL PRE
SSURE TEST
13.1 OBJECTIVE
:
To demonstrate the capability
of the air system to provide
pressuregradient among the
different room.
IA:CRITERIA
ACCEPTANCE
Differential pressure of rooms
As per design sheet + 0.5 m
m of water
13.3 PROCEDURE:STEP
ACTIONStart
1 All HVAC systems of the cle
an room facility are to be in co
ntinuousoperation when
performing these
tests.2 To avoid unexpected c
hanges in pressure and to est
ablish baseline, alldoors in
sterile facility must be closed
and no traffic is to be allowed
throughthe facility during the
test.3 Adjust the Magnehelic
gauge to give a reading of zer
o in accordance withthe
manufacturers
instructions.4 Connect one en
d of the tubes to the higher-
pressure side of the Magnehe
licgauge(Calibrated) & place
the other end of the tube in
the area of higherpressure
such that it is free from
obstruction and directed away
from
anyairflows.5 Next, connect o
ne end of the second tube to t
he lower pressure input sideo
f the Magnehelic gauge and
place the other end of the
tube in the area oflower
pressure such that it is free
from obstruction and directed
away fromany airflows. If the
tubing passes a surface
ensure that any gap
surroundingthe tube are
sealed.6 Record the pressure
displayed on the Magnehelic
gauge three times ,fordesign
differential pressure.7Record
the result [Reference is made
to
Annexure-VII]
.
End
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Page 20 of
14.0 TEMPERATURE CO
NTROL TEST
14.1 OBJECTIVE
:
To demonstrate the ability of
the AHU's to provide the
requiredtemperature in critical
and controlled areas.

IA:CRITERIA
ACCEPTANCE
Temperature of controlled
areas
NMT 25
0
C
14.3
PROCEDURE
STEP ACTIONStart
1Verify that the air
conditioning system is
operating in the stable
conditionand all equipment
that is specified is
running.2Divide the room
area in four equal zones test
as required by
thespecification or on a grid
pattern of 3m x
3m.3 Use calibrated Data log
ger to record the temperature.
4 Record the temperature for
location in each room .5Recor
d the result [Reference is
made to
Annexure-VI
].
End
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Page 21 of
15.0 HUMIDITY CONTRO
L TEST
15.1 OBJECTIVE
:
To demonstrate the capability
of air handling system to
control relativehumidity at the
specified level in each room
in critical area and controlled
areas.

IA:CRITERIA
ACCEPTANCE
Relative humidity in critical ar
ea NMT 50 %Relative humidit
y in controlled area NMT 55%
15.3
PROCEDURE
:
STEP ACTIONStart
1 Execute humidity control te
st after all the air balancing pr
ocedure have beenconcluded
and air conditioning system is
completely in operation and
stableconditions have been
achieved2 Use calibrated Dat
a Logger to record the relativ
e humidity.3 Record the relati
ve humidity in room as per lay
out of relative humidity record
ineach
room.4 Record the result for t
hree consecutive days [Refer
ence is made to Annexure-
VI].
End
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Page 22 of
16.0 LIGHT INTENSITY M
EASUREMENT: LUX ME
ASUREMENT
16.1 OBJECTIVE:
To determine the lighting
level and its uniformity
throughout an area at pre-
determined points
IA:CRITERIAACCEPTANCE
Light level Not less than 300 l
ux / As per Design Specificati
on
16.3 PROCEDURESTEP
ACTIONStart
1 Record the light levels on a
pre-
determined grid pattern/ layou
t of luxlevel or in the absence
of a specification on a 3m x
3m grid
pattern.2 Divide the room into
four equal locations.3 Record
the light level at working heig
ht or 750 mm above finished f
loorheight.4 The area under t
est must have all fitted lights
working and the areastructure
should be complete also if
required emergency lighting
levelscan be
recorded.5 Record the light le
vels in lux for each position o
n the grid [Reference ismade
to
AnnexureVII
].6 Note down all variations fr
om the specification if any.
End
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Page 23 of
17.0 NOISE LEVEL MEA
SUREMENT:
17.1 OBJECTIVE:
To determine the noise level
and its uniformity throughout
an areaat pre-determined
points.
IA:
CRITERIA
ACCEPTANCE
Noise level Not more than 85
dB / As per Design Secificatio
n
17.3 PROCEDURESTEP
ACTIONStart
1 Verify that the air conditioni
ng system is operating in the
stable conditionand all
equipment that is specified is
running [In operational
condition].2 Map out the area
under test as required by the
specification in a 2400 mmx
2400 mm x grid or on a
previously agreed location
basis i.e divide thearea into
fur equal
parts.3 Set the instrumentatio
n to work and ensure unautho
rized entry and exitsfrom the
room are
prevented.4 Measure the sou
nd levels at work surface heig
ht or 750 mm from thefinished
floor level and layout of noise
level.5Record the data
[Reference is made to
Annexure- VII
].6 Note down all variations fr
om the specification if any.
End
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Page 24 of
18.0 GENERAL REQUIR
MENTS:
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
hasUndersigned 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 t
he 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 protoc
ol and theJustification for the
deviation.
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Page 25 of
19.0
ANNEXUREANNEXURE I
(Air Velocity & ACPH
Calculation
)
Ambient Condition:- NMT
25° & 50-55%RH
Area/Room Name:
Test Performed Date:
Department:
Test End Date:
Code No.:
Next Due Date:
AHU No.:
Acceptance Criteria:
± 20%
Test:
Air Velocity & ACPH Calculation

Occupancy State:
At rest/ At operation
Equipment Used:Test
Method:
Observation Table:Obs.
Rdg.(m/s)/(ft/min)Sr.No.Filt
erTag No.
12345
Avg.VelocityCMM/CFMTota
lCMM/
CFMRoomVolumeACPHGr
aphical Representation:
Filters v/s CMH & Filters v/s
ACPH
Filters v/s CMH Filters v/s ACP
H
Conclusion:
Certified As Per ISO 14644
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Page 26 of
ANNEXURE II (Filter
Integrity test (DOP/PAO)
25° & 50-55%RH
Area/Room Name:
Department:
Test End Date:
Code No.:
Next Due Date:
AHU No.:
0.01% As Per ISO14644

Test:
Filter Integrity test (DOP/PAO)
Occupancy State:
Equipment Used:Test
Method:
Observation
Table:Sr.No.Filter
TagNo.ConcentrationUpstr
eamConc. %Leak in %DOP/
PAOTest ResultRemark
1 ---- ----
Graphical Representation:
Filters v/s Leak in
%Conclusion:
Certified As Per ISO 14644

Palghar
Performance
CLEAN ROOM
Page 27 of
ANNEXURE III (Air Flow
Visualization
)

25° & 50-55%RH
Area/Room Name:
Test Performed Date

:
Department:
Test End Date:
Code No.:
Next Due Date:
AHU No.:
Test Method:
Trace Injection Air
Flows Visualization
Test:
Air Flow Visualization

Occupancy State:
Equipment Used:
Observation
Table:Sr. No. Filter Tag No.
Flow Pattern Observed Re
markPhotographic
Representation:Conclusion
:
Certified As Per Design
Qualification.
Palghar
Performance
CLEAN ROOM
Page 28 of
ANNEXURE IV (Non –
Viable Particle Count
Measurement)
25° & 50-55%RH
Area/Room Name:
Department:
Test End Date:
Code No.:
Next Due Date:
AHU No.:
For Class:
Test:
Non – Viable Particle Count. Meas.

Occupancy State:
Equipment Used:Test
Method:
Observation Table:No. of
Particles Per
CFM/CMMLocationNo.Occu
pancyState
≥
0.5µ
≥
5µRemark
1 At rest2 At operation
Conclusion:
Meets/ Does not meets the
acceptance Criteria as per
ISO
14644/USFDA/USP/EU/GMP
.
Palghar
Performance
CLEAN ROOM
Page 29 of
ANNEXURE V (Recovery)
25° & 50-55%RH
Area/Room Name:

Department:
Test End Date:
Code No.:
Next Due Date:
AHU No.:
Test:
Recovery
Occupancy State
:
At rest
Equipment Used:Test
Method:
Observation Table:- For
ClassNo. of Partical Per
CFM/CMMLocationAHUST
ATUSTimeRequired
≥
0.5µm
≥
5µmRemarkConclusion:
Qualification.
Palghar
Performance
CLEAN ROOM
Page 30 of
ANNEXURE VI (Temp. &
RH Mapping)
25° & 50-55%RH
Area/Room Name:
Department:
Mapping Duration:
Code No.:
Frequency of Rdg.:
AHU No.:
Test:
Temp. & RH Mapping
Next Due Date:
Equipment Used:No. of
Channel:Occupancy State:
Schematic Diagram:
Palghar
Performance
CLEAN ROOM
Page 31 of
Mapping Observations
Table:
PositionsP1 P2 P3 P4
P5TimeTemp RH Temp RH
Temp RH Temp RH Temp RH
Palghar
Performance
CLEAN ROOM
Page 32 of
[Temperature (
O
C) v/s Time]
[Relative Humidity (% RH)
v/s Time]
Conclusion:
Qualification.
Palghar
Performance
CLEAN ROOM
Page 33 of
ANNEXURE VII
(Differential Pressure &
Lux Level Measurement)
25° & 50-55%RH
Area/Room Name:
Department:
Test End Date:
Code No.:
Next Due Date:
AHU No.:
Test:
Test Method:
Equipment Used:Occupancy
State:
Observation Table: (For
Differential Pressure)Actual
Press. (mm of H
2
O)Designed Press.mm of of
H
2
O
123
mm of H
2
OAverageRemarkConclusi
on:
Qualification.
Lux Level)Actual
(Lux)Designed(Lux)
123
Average(Lux)RemarkConcl
usion:
Qualification.
Palghar
Performance
CLEAN ROOM
Page 34 of
ANNEXURE VIII (Sound
Level (dB))
Sound Level)Actual
(dB)Design (dB)1 2
3Average (dB) RemarkCon
clusion:
Qualification.
Palghar
Performance
CLEAN ROOM
Page 35 of
20.0 REFERENCE:-
NO. CODE TITLE
1 ISO 14644 Clean Room &
Associated Environment2 VM
P-
2006 Validation Master Plan.
3 SCH.M Pt. I-
A Drug and Cosmetics act 19
40.4 Annex 6 WHO Technical
report series No 902, 2002.5
USP 2005 USP NF the Offici
al compendia of standards.6
EC GUIDE EC guide to good
manufacturing practice annex
ure-1 September 2003.

Performance Qualification

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Performance Qualification

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Performance

HEPA Filter leak testing

Air flow pattern test (Smoke

Nonviable particulate counts

Monitoring of relative humidity

Area light level measurement

To be performed once in six

TSI Hot wire Anemometer /

Fog generator (Smoke gener

Airborne Non viable Particle

Calibrated Temperature &

Noise level meter-dBA meter

To demonstrate that the

Air velocity and ACPH As per

To demonstrate and validate

9.2 ACCEPTANCE CRITERI

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

17If any leakage observed

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

11.2 ACCEPTANCE CRITER

2 Measure on a centered grid

The number of sub-areas is

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

To determine the recovery

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

14.2 ACCEPTANCE CRITER

15.2 ACCEPTANCE CRITER

Test Performed Date:

Test End Date:

Next Due Date:

Air Velocity & ACPH Calculation

Test End Date:

Next Due Date:

0.01% As Per ISO14644

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

Ambient Condition:- NMT

Test Performed Date

Test End Date:

Next Due Date:

Air Flow Visualization

Test Performed Date:

Test End Date:

Next Due Date:

Non – Viable Particle Count. Meas.

Test Performed Date:

Test End Date:

Next Due Date:

Test Performed Date:

Test End Date:

Next Due Date:

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