Ahu 1a

PERFORMANCE QUALIFICATION
Equipment Name AIR HANDLING UNIT

Protocol Number PQ/CP/028/01
Facility
UNIT-I Block C
Equipment Number AHU 1A

Effective Date
24.10.2001
Module
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TABLE OF CONTENTS
01.0 PROTOCOL APPROVAL..............................................................................................2

02.0 OBJECTIVE...................................................................................................................3
03.0 SCOPE..........................................................................................................................3
04.0 EXECUTION TEAM......................................................................................................4
05.0 EQUIPMENT / SYSTEM DESCRIPTION.....................................................................5
06.0 ACCEPTANCE AND REVALIDATION CRITERIA.......................................................7
07.0 TEST PROCEDURE....................................................................................................8
Calculations...........................................................................................................................9
1. Total Air Flow CFM............................................................................................................9
IPQC 10
FIRST FLOOR.....................................................................................................................12
RESULT
..........................................................................................................................55
08.0 DEFICIENCY AND CORRECTIVE ACTION REPORT............................................56

09.0 SUMMARY AND EVALUATION OF RESULTS .........................................................57
58
10.0 FINAL REPORT APPROVAL......................................................................................59
11.0 APPENDIX................................................................................................................60
Form No: APL/QA/F012-00/06-2001
Facility
UNIT-I Block C
01.0
PROTOCOL APPROVAL
01.1
Protocol Prepared by

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Preparation of this qualification plan is the responsibility of Validation Coordinator of the

Task Force II
NAME
Mr. R. Sridhar Reddy
01.2
TITLE
Deputy ManagerValidation
SIGNATURE
DATE
Protocol checked by
Checking of this qualification plan is the responsibility of Validation Task Force Leader
01.3
NAME
TITLE
Dr. A. Dikshit
Manager- QA & RA
SIGNATURE
DATE
Protocol Approved by
Pre approval of this qualification plan is the responsibility of the Validation Core
Committee
NAME
Mr. S. Baji Saida
Mr. V. Ramulu
Dr. A. R. M Rao
Form No: APL/QA/F012-00/06-2001
DESIGNATION
Asst. ManagerMaintenance
Sr. Manager
Works
HeadQuality Assurance &
Regulatory Affairs
SIGNATURE
DATE
Facility
UNIT-I Block C
02.0

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OBJECTIVE
The objective of this protocol is to provide an outline for the Verification of Performance
of Air Handling Unit (AHU- 1A) against the predetermined acceptance criteria, when
operated as per the set standard operating procedures.
03.0
SCOPE
The scope of this protocol is to establish final
Standard Operating Procedures
Standard Cleaning Procedures
Critical process control checkpoints,
Critical Process control points,
Alert and action limits
Form No: APL/QA/F012-00/06-2001
Facility
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04.0

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EXECUTION TEAM
Name
Mr. Vijay Gornale
Mr. A. Kameswara Rao
Mr. N. Sridhar Reddy
Form No: APL/QA/F012-00/06-2001
Responsibility
To provide Engineering
support for execution
To
provide
protocols/
datasheets and monitor the
execution.
To perform and provide
adequate manpower to
carryout the activity.
Designation
Asst. ManagerEngineering
Sr. AssistantQ.A
Sr. Executive
Production
Signatures
Facility
UNIT-I Block C
05.0

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EQUIPMENT / SYSTEM DESCRIPTION
Air handling unit is a close system, which re-circulates the air free from particulate matter
to different areas. Following parts are installed in the system. (Diagram Enclosed)
1. Pre Filter
2. Mixing Chamber
3. Cooling and Heating coil
4. Centrifugal Blower (Supply)
5. Microvee and HEPA Filters
6.
Supply Air Plenum
7.
Volume and Fire Control Dampers
8.
Supply and Return Air grills / diffusers
9.
Return Air Plenum
10. Centrifugal Blower (Return)

This is a close box type construction having a Chamber for Mixing the Fresh and the
Return air. The fresh air is made to pass through the 10 filter. The Cooling and
Heating coils are fixed in these chambers. There are 2 more chambers, one for
Centrifugal Blower (Supply) and another one for Centrifugal Blower (Return).
The AHU connected to the Level II area is provided with 0 leak dampers for fresh air
and return air so that the system can become automatically once through upon
detection of higher level of solvent concentration by solvent sensor provided in
conditioned space.
Filters
The Pre-filter is made of Synthetic non-woven media supporting by HDPE having

an efficiency of 90% at 10.
The Microvee Filter is made of Synthetic non-woven media supporting by HDPE

having an efficiency of 99% at 5..
The HEPA filter is made of Micro fiberglass having an efficiency of 99.97% at 0.3.
Form No: APL/QA/F012-00/06-2001
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EQUIPMENT / SYSTEM DESCRIPTION (Continued)
The total volume of air is supplied to the different areas with the help of supply duct,
which is made-up of G.I. metal and the air returns to the return air plenum and
exhausted.
Dampers (Volume and Fire Control)
At the junction of each branch duct with main duct and split of main duct, Volume
control dampers are provided.
Fire dampers are of automatic type. These automatic fire dampers shall be capable of
operating automatically on receiving signal from a fire alarm panel. Fire dampers are
connected to a separate panel connected with remote control to achieve audio video
alarm in case of damper closure.
All supply and return air ducts in air handling units and main branches shall be
provided with approved fire dampers of at least 2 hours fire rating. Fire damper blades
shall be one piece folded high strength galvanized steel construction. In normal
position, these blades shall be gathered and stacked at the frame head providing
maximum air passage and preventing passing air current from creating noise chatter.
The blades shall be held in position through fusible links.
Capacity
The AHU-1A has a capacity of 13750 CFM and supplies to the Level II Area. The AHU
covers both the Ground Floor and First Floor Process Areas.
The Following areas are covered by the Air Handling Unit 1A.
GROUND FLOOR
1.
2.
3.
4.
5.
6.
7.
8.
9.
Change Room
Corridor
Office room
IPQC room
Technical Centrifuge area
Crystallizer (Pharma centrifuge) area
Reactor overhanging area
Sparkler Filter & Wash area
Tray dryer & Milling area
Form No: APL/QA/F012-00/06-2001
FIRST FLOOR
1.
2.
3.
4.
5.
Intermediate Reactors area

Weighing and Dispensing room
Intermediate Storage room
Dispensed Raw Material Store
Crystallizer area
Facility
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06.0
ACCEPTANCE AND REVALIDATION CRITERIA
06.1
ACCEPTANCE CRITERIA
06.1.1
The air velocity should be higher than 90 FPM. Air changes should meet to
design criteria.
06.1.2
Efficiency of HEPA filter should not be less than 99.97%.
06.1.3
The particle count of the area should not be more than 100 000 ( 0.5 size)
and 700 ( 5.0 size) per cubic feet under At Rest Condition.
06.1.4
The flow direction should be from positive Pressure to negative pressure.
06.1.5
The temperature of the area should be 23 2OC and the Humidity should be
less than 60%.
06.2
REVALIDATION CRITERIA :
System should be revalidated under following conditions.
06.2.1 Whenever a major changes have been done in the system.

06.2.2 For
Air Velocity & Air Changes

Particle count At Rest Condition
Filter integrity Test (DOP)
Form No: APL/QA/F012-00/06-2001
- Yearly Twice
- Yearly Twice
- Yearly once
Facility
UNIT-I Block C

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07.0
TEST PROCEDURE
07.1
AIR VELOCITY AND AIR CHANGES TEST
a)
Purpose
To demonstrate that the air system is balanced and capable of delivering sufficient
air volume to maintain a minimum cross sectional velocity under the absolute filter
b)
c)
Equipment and Instrument

Anemometer Make
Model
Procedure
07.1.1
These tests are executed in every room where an diffuser is installed.
07.1.2
Keep the Anemometer range as 0 - 1500 FPM.
07.1.3
Keep the probe at 1.5 to 2 below the Diffuser / grill and velocity recording to
be noted.
07.1.4
Each diffuser / grill requires minimum 4 tests spots. Measure the air velocity at 4
corners of the diffuser/grill.
07.1.5
Allow no object within 10 ft of the Anemometer. Minimize the no of people during

at rest testing.
07.1.6
Measurement should be taken for a minimum of 15 seconds.
07.1.7
Calculate the CFM and Air changes.
Form No: APL/QA/F012-00/06-2001
Facility
UNIT-I Block C
d)

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Acceptance Criteria
The air changes per hour should be as per the Design Qualification.
NOTE
10% variation of actual CFM with respect to the Design CFM is acceptable at
each outlet. But the Total CFM in a room should not be less than the Design
CFM.
All Damper positions are marked permanently after air balancing.
V1
V3
Calculations
V2
V4
1. Total Air Flow CFM

FPM x Area of Diffuser/Grill
2. Air Changes
Total CFM x Time (60 minutes)
__________________________
Volume of Room (ft3)
Form No: APL/QA/F012-00/06-2001
Where, FPM is Feet per minute

CFM is Cubic Feet per minute
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AIR VELOCITY AND AIR CHANGES TEST RESULTS
Room Name
Diffuser/Grill
Size
(L x B)
CHANGE ROOM
CORRIDOR
OFFICE
IPQC
PHARMA
CENTRIFUGE AREA
REACTOR OVER
HANGING AREA
TECHNICAL
CENTRIFUGE AREA
SPARKLER FILTER/
WASH AREA
TRAY DRYER/
MILLING AREA
INTERMEDIATE
REACTORS AREA
CRYSTALLIZER
AREA
R.M STORAGE
AREA
WEIGHING /
BALANCING AREA
R.M DISPENSING
AREA
Form No: APL/QA/F012-00/06-2001
Qty of
Diffuser/Grill
Diffusers
Area (Ft2)
/ grills
(Filter size x Qty)
Room Volume
(Ft3)
(L x B x H)
Facility
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GROUND FLOOR:
Room Name
Diffuser
/Grill
No.
Air Velocity
V1
V2
V3
V4
Average
Velocity
FPM
Total
Air flow
CFM
No. Of
Air
Changes
Average
Total
No. Of
Change Room
Corridor
Office Area
IPQC Area
Pharma
Centrifuge
Area
Reactor Over
hanging area
Tech.
Centrifuge
Area
Room Name
Diffuser
Form No: APL/QA/F012-00/06-2001
Air Velocity
Facility
UNIT-I Block C
/Grill
No.
V1
V2

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V3
V4
Velocity
FPM
Air flow
CFM
Air
Changes
Average
Velocity
FPM
Total
Air flow
CFM
No. Of
Air
Changes
Sparkler
Filter/Wash
Area
Tray Dryer /
Milling Area
FIRST FLOOR
Room Name
Diffuser
/Grill
No.
Intermediate
Reactors Area
Crystallizer
Area
Raw material
Storage area
Weighing /
Balance area
Raw Material
dispense area
Acceptance Criteria
Form No: APL/QA/F012-00/06-2001
Air Velocity
V1
V2
V3
V4
Facility
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10% of variation of actual CFM with respect to the design CFM is acceptable at each
outlet , but the total CFM in a room should not be less than the desired CFM.
RESULT
The CFM and air changes of the area meets / does not meet with the designed criteria, so
area PASSES / FAILS in the above mentioned test.
Name
Checked by
Reviewed by
Form No: APL/QA/F012-00/06-2001
Department
Signature
Date
Facility
UNIT-I Block C
07.2
FILTER INTEGRITY TEST
a)
Purpose

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To ensure that the HEPA filters installed are not damaged during transit,
installation or operation and / or fixed properly in the appropriate place, such that
there is no leakage from the filter media and the other joint gaskets, frames etc)
b)
c)
Equipments and Instruments

Aerosol Generator
Model No:
Make
Aerosol Photometer
Model No:
Make
Procedure
07.2.1
Filter integrity test is performed after Operational air velocities have been
verified and adjusted.
07.2.2
Introduce the DOP cloud / Aerosol as a challenge agent into the upstream side
of the HEPA filter system and searching for leaks down stream with an aerosol
photometer.
07.2.3
Adjust the aerosol photometer such that the pressure is in the range of 1to 2
kg/cm2.
07.2.4
Position the smoke generator to the pre-filter so that DOP aerosol will be
introduced into the upstream system ahead of HEPA filters.
07.2.5
Once the 100% setting are established at the upstream side turn the instrument
Knob to down stream. Keep the scanning probe 1 below the HEPA filter grill,
and start scanning the HEPA filter face area and fitment of HEPA filter with
frame.
Ensure that the scanning speed does not exceed 10 ft /min velocity.
Form No: APL/QA/F012-00/06-2001
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07.2.6
In case of Flange type HEPA filter, the scanning is to be done at minimum 5

below the HEPA filter to avoid the confusion created by some % value of
aerosol penetration at the dead area (i.e flange surfaces)
07.2.7
If any leak is observed then take out the grill and retest it. Assure that the
leakage is coming through the fitment part or HEPA Filter itself.
07.2.8
If fitment leakage is there, tightening the HEPA filter fitment with pressure plate
can arrest it. And if the HEPA filter leakage is still there, the joint can be sealed
by silicon sealant, but should not exceed more than 5% of the surface area.
7.2.9
Make separate passes with the photometer probe, ground the entire periphery of
the filter, along the bond between filter medium and frame and along other joints in
the filter.
d)
Acceptance Criteria
Any leakage greater than 0.03% of the upstream challenge aerosol
concentration is considered unacceptable and wants repairs and resetting.
Repair patches on the HEPA Filter should not exceed a maximum of 5% of the
total filter area and individual sealed area should not be more than 1 in 2
In case if the sealed area is more than 5% and / or any individual sealed area is
more than 1 in2 then the filter should be rejected and replaced with the new one.
Form No: APL/QA/F012-00/06-2001
Facility
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HEPA FILTER INTEGRITY TEST RESULTS

Location
Air handling Unit Housing
Test
DOP
Equipment used
Date of test
S. No
HEPA
Filter No
Upstream
Penetration
(%)
Down stream
Penetration
(%)
Efficiency
(%)
Remarks
RESULT
Efficiency of filter is as per the limit / out of the limit and there is no leakage found, so the
filter integrity test PASSES / FAILS.
Name
Checked by
Reviewed by
Form No: APL/QA/F012-00/06-2001
Department
Signature
Date
Facility
UNIT-I Block C

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07.3 TEMPERATURE, RELATIVE HUMIDITY AND PRESSURE DIFFERENTIAL

MONITORING
a)
Purpose
To demonstrate that the HVAC system is capable of achieving the desired set of
environmental conditions (Temperature, RH Pressure differentials in the subjected
area / room.)
1)
Owing to criticality of product /process handling, Corridors, Drying/Milling,

Sifter room, Blender room, Packing area and F.G Quarantine area are
provided with probes and indicators for Temperature, Relative Humidity and
Pressure differential. These areas will be monitored in At rest and In
Operation conditions during performance qualification studies.
2)
Temperature sensors (only for PQ studies) are placed in the following

areas. These sensors are temporary and meant only for the above studies.
All these areas /rooms are identified as non-critical; hence Temperature will
be monitored only in At rest conditions. Temperature monitoring during
operation is excluded from the scope of this study.
GROUND FLOOR
FIRST FLOOR
1. Change Room
2. Office Area
3. IPQC Area
4. Crystalizer Area
5. Reactor Over Hang Area
6. Technical Centrifuge Area
7. Sparkler Filter & Wash Area
8. Tray Dryer/Milling area
b)
9. Intermediate Reactors Area

10. Crystallizer Area
11. Raw Material Storage Area
12. Weighing / Balancing Area
13. Raw material dispensing Area
14. Equipment wash area
15. Material Airlock area
16. Clean Equipment area
Equipment and Instruments
Data Logger
Make :
Model No.
Calibration Range
Form No: APL/QA/F012-00/06-2001
: M/s Polmon Instruments Pvt. Ltd.,

: DL 120
: -50C to + 300C
Facility
UNIT-I Block C
Temperature Sensors
Make
: M/s Polmon Instruments Pvt. Ltd.,
Model No.
: DPI-20R
Sensor range
: -25C to +75C.
Calibrated digital global indicators (only for critical areas/rooms)
Make
Thermometer with RTD
Sensor range
Differential Pressure
Indicator Range
c)

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: M/s Global Electronics

: -10C to 250C (Temperature)
: 0 to 100% (Relative Humidity)
: 0 to 100 mm WC.
Procedure
07.3.1 Execute these tests after all the balancing procedures have been concluded.
07.3.2 Air conditioning system should be in operation for at least 24 hour prior to
performing this test.
07.3.3 All lights in the subjected room should be kept on during the testing as well as
during the preconditioning period.
07.3.4 Record the temperature, Relative Humidity and Pressure differentials for corridor
area and record the temperature in remaining areas for 72 hours at the time
interval of 1 hour in Annexure - 2
07.3.5 This test should be carried out at rest (Static) and In operation (dynamic)
conditions in corridor area only. Remaining areas will be monitored in At rest
(Static) condition only.
07.3.6 Plot the trend charts for the studied parameters*.
Acceptance Criteria
The temperature is 232C (21 to 25C), Relative Humidity Not more than 60% and the
Pressure Differentials as per the design (0.5 mm WC).
Form No: APL/QA/F012-00/06-2001
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Trend charts shall be enclosed in Annexure - 3
Form No: APL/QA/F012-00/06-2001
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Table No : 1 Environmental control recording chart for At rest Condition
Time (Hrs)
Change Room
Office Area
IPQC Area
Temp
(C)
Temp
(C)
Temp
(C)
Pharma Centrifuge
Area
Temp
(C)
Form No: APL/QA/F012-00/06-2001
Facility
UNIT-I Block C
Time (Hrs)

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Change Room
Office Area
IPQC Area
Temp
(C)
Temp
(C)
Temp
(C)
Pharma Centrifuge
Area
Temp
(C)
Time (Hrs)
Change Room
Office Area
IPQC Area
Temp
Temp
Temp
Form No: APL/QA/F012-00/06-2001
Pharma Centrifuge
Area
Temp
Facility
UNIT-I Block C
(C)
Form No: APL/QA/F012-00/06-2001
(C)

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(C)
(C)
Facility
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Change Room
Office Area
IPQC Area
Temp
(C)
Temp
(C)
Temp
(C)
Time (Hrs)
Pharma Centrifuge
Area
Temp
(C)
Acceptance Criteria
Temperature
: 21 to 25C
Name
Checked by
Reviewed by
Form No: APL/QA/F012-00/06-2001
Department
Signature
Date
Facility
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Time (Hrs)
Reactor Over
Hanging Area
Temp
(C)
Form No: APL/QA/F012-00/06-2001
Tech. Centrifuge
Area
Temp
(C)
Sparkler Filter /
Wash Area
Temp
(C)
Tray Dryer/ Milling

Area
Temp
(C)
Facility
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Time (Hrs)
Reactor Over
Hanging Area
Temp
(C)
Form No: APL/QA/F012-00/06-2001
Tech. Centrifuge
Area
Temp
(C)
Sparkler Filter /
Wash Area
Temp
(C)
Tray Dryer/ Milling

Area
Temp
(C)
Facility
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Time (Hrs)
Reactor Over
Hanging Area
Temp
(C)
Form No: APL/QA/F012-00/06-2001
Tech. Centrifuge
Area
Temp
(C)
Sparkler Filter /
Wash Area
Temp
(C)
Tray Dryer/ Milling

Area
Temp
(C)
Facility
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Time (Hrs)
Reactor Over
Hanging Area
Temp
(C)
Tech. Centrifuge
Area
Temp
(C)
Sparkler Filter /
Wash Area
Temp
(C)
Tray Dryer/ Milling

Area
Temp
(C)
Acceptance Criteria
Temperature
: 21 to 25C
Name
Checked by
Reviewed by
Form No: APL/QA/F012-00/06-2001
Department
Signature
Date
Facility
UNIT-I Block C

Effective Date
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Time (Hrs)
Intermediate
Reactor Area
Temp
(C)
Form No: APL/QA/F012-00/06-2001
Crystallizer Area
Temp
(C)
Raw material
storage Area
Temp
(C)
Weighing / Balance
Area
Temp
(C)
Facility
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Time (Hrs)
Intermediate
Reactor Area
Temp
(C)
Form No: APL/QA/F012-00/06-2001
Crystallizer Area
Temp
(C)
Raw material
storage Area
Temp
(C)
Weighing / Balance
Area
Temp
(C)
Facility
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Time (Hrs)
Intermediate
Reactor Area
Temp
(C)
Form No: APL/QA/F012-00/06-2001
Crystallizer Area
Temp
(C)
Raw material
storage Area
Temp
(C)
Weighing / Balance
Area
Temp
(C)
Facility
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Time (Hrs)
Intermediate
Reactor Area
Temp
(C)
Crystallizer Area
Temp
(C)
Raw material
storage Area
Temp
(C)
Weighing / Balance
Area
Temp
(C)
Acceptance Criteria
Temperature
: 21 to 25C
Name
Department
Signature
Checked by
Reviewed by
Time (Hrs)
Raw material
Form No: APL/QA/F012-00/06-2001
Corridor
Date
Facility
UNIT-I Block C
Dispensing Area
Temp
(C)
Temp
(C)

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RH
(%)
PD
(mm WC)
Time (Hrs)
Raw material
Dispensing Area
Temp
(C)
Form No: APL/QA/F012-00/06-2001
Corridor
Temp
(C)
RH
(%)
PD
(mm WC)
Facility
UNIT-I Block C
Form No: APL/QA/F012-00/06-2001

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Facility
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Time (Hrs)
Raw material
Dispensing Area
Temp
(C)
Form No: APL/QA/F012-00/06-2001
Corridor
Temp
(C)
RH
(%)
PD
(mm WC)
Facility
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Time (Hrs)
Raw material
Dispensing Area
Temp
(C)
Corridor
Temp
(C)
RH
(%)
PD
(mm WC)
Acceptance Criteria
Temperature
: 21 to 25C
Relative Humidity
: Not More Than 60%
Pressure Differentials : 0.5 mm WC.
Name
Checked by
Reviewed by
Form No: APL/QA/F012-00/06-2001
Department
Signature
Date
Facility
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Effective Date
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Table No : 2 Environmental control recording chart for In Operation Condition

Time (Hrs)
Form No: APL/QA/F012-00/06-2001
Temp
(C)
Corridor
RH
(%)
PD
(mm WC)
Facility
UNIT-I Block C

Effective Date
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Module
I
Page No
37 of 60

Time (Hrs)
Form No: APL/QA/F012-00/06-2001
Temp
(C)
Corridor
RH
(%)
PD
(mm WC)
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
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Time (Hrs)
Form No: APL/QA/F012-00/06-2001
Temp
(C)
Corridor
RH
(%)
PD
(mm WC)
Facility
UNIT-I Block C

Effective Date
24.10.2001
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I
Page No
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Table No : 2Environmental control recording chart for In Operation Condition

Time (Hrs)
Temp
(C)
Corridor
RH
(%)
PD
(mm WC)
Acceptance Criteria
Temperature
: 21 to 25C
Relative Humidity
: Not More Than 60%
Pressure Differentials : 0.5 mm WC.
Name
Checked by
Reviewed by
Form No: APL/QA/F012-00/06-2001
Department
Signature
Date
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
40 of 60
07.4
NON VIABLE AIR BORNE PARTICULATE COUNT TEST (At Rest Condition)
a)
Purpose
To demonstrate that the clean rooms and critical work locations within the clean
rooms comply with the design qualification during the At Rest Condition and as
per the Federal standard 209E
b)

Laser Particle Counter
c)
Procedure
07.4.1 After the Environmental control Test, clean the entire Room and allow the Air
Conditioning system to run for at least 7-8 hours with no man or material
Movement inside the room.
07.4.2 With the help of Laser Particle counter, count the non-viable airborne particles at
working height about 40 inches from the floor.
07.4.3 Count particles greater than 0.5 micron and 5.0 micron diameter at 5 locations on
each filter grid and in the subjected clean room.
07.4.4
Find out the Mean, Standard Deviation, Standard Error and Calculate the UCL for
particles 0.5 and 5.0 . Record the results.
07.4.5 Calculate the reading as per the formula mentioned below

(M) =
a 1 + a 2 + ..... + a i
n
(SEM) =
(SD) =
(a 1 - M) 2 + (a 2 - M) 2 + ..... + (a i - M) 2
(n - 1)
SD
n
Where, n = number of observations.

UCL factor for 95% upper confidence limit for different number of locations is
indicated in the following table.
Form No: APL/QA/F012-00/06-2001
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
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UCL Factor for 95% upper confidence limit

3
4
5
6
7
8
9
No. of locations
2
>9*
(L)
95% UCL Factor
6.31
2.92
2.35
2.13
2.02
1.94
1.90
1.86
NA
* When the number of locations is greater than 9, the calculation of a UCL is not required.
07.4.6 In case there is a deviation from acceptance criteria, various components related
to the system operation are need to be reviewed and accordingly adjustments to
be done.
Acceptance Criteria
Class 100 000
0.5 Micron Not more than 100 000
5.0 Micron Not more than 700
Note
The particle Count locations for the specified clean room shall be enclosed with
the results sheet.
Form No: APL/QA/F012-00/06-2001
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
42 of 60
NON VIABLE AIRBORNE PARTICLE COUNT RESULTS IN AT REST CONDITION

1.
CHANGE ROOM
Room
Name
Location
Non viable air borne particle counts (per

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5
Average Counts at
each locations (a)
0.5
5.0
Mean of the average (M)

Standard Deviation of the averages (SD)
Standard error of the mean of the averages (SEM)
b) Calculations
Upper Confidence limit (UCL0.5)

UCL = M + (UCL Factor X SEM)
UCL =
UCL =

UCL =
UCL =
c)
RESULT
The average particle concentration are less than ________ / _______ so the above data meets
the acceptance criteria for class _________
Name
Checked by
Reviewed by
Form No: APL/QA/F012-00/06-2001
Department
Signature
Date
Facility
UNIT-I Block C
2.
Room
Name
Location

Effective Date
24.10.2001
Module
I
Page No
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CORRIDOR AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5
Average Counts at
each locations (a)
0.5
5.0

b) Calculations

UCL =
UCL =

UCL =
UCL =
c)
RESULT
Name
Department
Signature
Date
Checked by
Reviewed by
3.
Room
Name
Location
Form No: APL/QA/F012-00/06-2001
OFFICE AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5
Average Counts at
each locations (a)
0.5
5.0
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
44 of 60

b) Calculations

UCL =
UCL =

UCL =
UCL =
c)
RESULT
Name
Department
Signature
Date
Checked by
Reviewed by
4.
Room
Name
Location
IPQC AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5

Form No: APL/QA/F012-00/06-2001
Average Counts at
each locations (a)
0.5
5.0
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
45 of 60
b) Calculations

UCL =
UCL =

UCL =
UCL =
c)
RESULT
Name
Department
Signature
Date
Checked by
Reviewed by
5.
Room
Name
Location
PHARMA CENTRIFUGE AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5
Average Counts at
each locations (a)
0.5

b) Calculations

Form No: APL/QA/F012-00/06-2001

5.0
Facility
UNIT-I Block C
UCL =

Effective Date
24.10.2001
Module
I
Page No
46 of 60
UCL =
UCL =
UCL =
c)
RESULT
Name
Department
Signature
Date
Checked by
Reviewed by
6.
Room
Name
Location
REACTOR OVER HANGING AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5
Average Counts at
each locations (a)
0.5
5.0

b) Calculations

UCL =
UCL =

UCL =
UCL =
c)
RESULT
Name
Form No: APL/QA/F012-00/06-2001
Department
Signature
Date
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
47 of 60
Checked by
Reviewed by
7.
Room
Name
Location
TECH. CENTRIFUGE AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5
Average Counts at
each locations (a)
0.5
5.0

b) Calculations

UCL =
UCL =

UCL =
UCL =
c)
RESULT
Name
Department
Signature
Date
Checked by
Reviewed by
8.
Room
Name
Location
Form No: APL/QA/F012-00/06-2001
SPARKLER FILTER / WASH AREA

Cu. Ft)
0.5
5.0
Average Counts at
each locations (a)
0.5
5.0
Facility
UNIT-I Block C
1

Effective Date
24.10.2001
Module
I
Page No
48 of 60
4

b) Calculations

UCL =
UCL =

UCL =
UCL =
c)
RESULT
Name
Department
Signature
Date
Checked by
Reviewed by
9.
Room
Name
Location
TRAY DRYER / MILLING AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5

Form No: APL/QA/F012-00/06-2001
Average Counts at
each locations (a)
0.5
5.0
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
49 of 60

b) Calculations

UCL =
UCL =
c)

UCL =
UCL =
RESULT
Name
Department
Signature
Date
Checked by
Reviewed by
10.
Room
Name
Location
CRYSTALLIZER AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5

b) Calculations
Form No: APL/QA/F012-00/06-2001
Average Counts at
each locations (a)
0.5
5.0
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
50 of 60

UCL =
UCL =

UCL =
UCL =
c)
RESULT
Name
Department
Signature
Date
Checked by
Reviewed by
11.
Room
Name
Location
INTERMEDIATE REACTORS AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5
Average Counts at
each locations (a)
0.5
5.0

b) Calculations

UCL =
UCL =
Form No: APL/QA/F012-00/06-2001

UCL =
UCL =
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
51 of 60
c)
RESULT
Name
Department
Signature
Date
Checked by
Reviewed by
12.
Room
Name
Location
RAW MATERIAL STORAGE AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5
Average Counts at
each locations (a)
0.5
5.0

b) Calculations

UCL =
UCL =

UCL =
UCL =
c)
RESULT
Name
Checked by
Reviewed by
Form No: APL/QA/F012-00/06-2001
Department
Signature
Date
Facility
UNIT-I Block C
13.
Room
Name
Location

Effective Date
24.10.2001
Module
I
Page No
52 of 60
WEIGHING / BALNCE AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5
Average Counts at
each locations (a)
0.5
5.0

b) Calculations

UCL =
UCL =

UCL =
UCL =
c)
RESULT
Name
Department
Signature
Date
Checked by
Reviewed by
14.
Room
Name
Location
Form No: APL/QA/F012-00/06-2001
RAW MATERIAL DISPENSING AREA

Cu. Ft)
0.5
5.0
1
2
3
4
5
1
2
3
4
5
Average Counts at
each locations (a)
0.5
5.0
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
53 of 60

b) Calculations

UCL =
UCL =

UCL =
UCL =
c)
RESULT
Name
Checked by
Reviewed by
Form No: APL/QA/F012-00/06-2001
Department
Signature
Date
Facility
UNIT-I Block C
07.5
SOUND LEVEL TEST
a)
Purpose

Effective Date
24.10.2001
Module
I
Page No
54 of 60
To measure the air borne sound pressure levels produced by the basic clean room
mechanical and electrical systems within the room and in adjacent external
occupied areas and to verify that it is in the acceptable range.
b)
c)
Procedure
07.5.1 Divide the work zone entrance plane into a grid of equal areas, the areas
should not exceed 430 Sq.ft.
07.5.2 Support the Sound level meter on the stand with the microphone Approx.
1.5 meter above floor and 3 meters away from the equipment.
07.5.3
07.5.4
d)
Measure and record the sound pressure level for each octave band (63 to 8000
Hz) in the center of each grid.
Record all measurements and corresponding grid locations.
Acceptance Criteria
Less than 65 db A at the work area against an ambient of 55 db A units for LAF
units.
Less than 70 db A against the ambient of 55 db A at the work area of Material
handling Equipments.
Form No: APL/QA/F012-00/06-2001
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
55 of 60
Sound Level Result sheet

Room Name
Locations
Sound Level Value in

db A Scale
CHANGE ROOM
CORRIDOR
OFFICE AREA
IPQC AREA
PHARMA CENTRIFUGE AREA
REACTOR HANGING AREA
TECH CENTRIFUGE AREA
SPARKLER FILTER/WASH
AREA
TRAY DRYER/MILLING AREA
INTERMEDIATE REACTORS
AREA
CRYSTALLIZER AREA
R.M STORAGE AREA
WEIGHING BALANCE AREA
DISPENSED R.M AREA
Acceptance Criteria
Less than 65 db A at the work area against an ambient of 55 db A units for LAF units.
Less than 70 db A against the ambient of 55 db A at the work area of Material handling
Equipments.
RESULT
The Sound level test was found to be within limits, hence the rooms PASS / FAIL for the
test.
Name
Checked by
Reviewed by
Form No: APL/QA/F012-00/06-2001
Department
Signature
Date
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
56 of 60
08.0 DEFICIENCY AND CORRECTIVE ACTION REPORT

08.1
Description of deficiency and date observed
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------08.2
Person responsible for corrective action and date assigned
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------08.3
Corrective actions taken and date conducted
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------SIGNATURES
Conducted By:
Date:
Approved By:
Date:
Form No: APL/QA/F012-00/06-2001
Facility
UNIT-I Block C
09.0

Effective Date
24.10.2001
Module
I
Page No
57 of 60
SUMMARY AND EVALUATION OF RESULTS
Form No: APL/QA/F012-00/06-2001
Facility
UNIT-I Block C
09.1
FINAL REPORT
Form No: APL/QA/F012-00/06-2001

Effective Date
24.10.2001
Module
I
Page No
58 of 60
Facility
UNIT-I Block C
10.0

Effective Date
24.10.2001
Module
I
Page No
59 of 60
FINAL REPORT APPROVAL
CHECKED BY VALIDATION CO-ORDINATOR

The Signature of checked by indicates that the qualification protocol was executed and all
tests cases and discrepancies were properly documented.
Mr. R.SRIDHAR REDDY
_____________________
Name
___________________
Signature
________________
Date
Approval of this qualification is the responsibility of Validation Core Committee

MAINTENANCE
The signature of Maintenance indicates that the results have been reviewed and is in
agreement with those results and their conclusions
Mr. BAJI SAIDA
_____________________
Name
___________________
Signature
________________
Date
MANUFACTURING
The signature of Manufacturing indicates that the results have been reviewed and is in
agreement with those results and conclusions
Mr. V.RAMULU
_____________________
Name
___________________
Signature
________________
Date
QUALITY ASSURANCE
The signature of Quality Assurance indicates that qualification, documentation and reports
have been reviewed and they meet the requirements specified
Dr. A.R.M RAO
_____________________
Name
___________________
Signature
Now the equipment is READY FOR OPERATION
Form No: APL/QA/F012-00/06-2001
________________
Date
Facility
UNIT-I Block C

Effective Date
24.10.2001
Module
I
Page No
60 of 60
11.0 APPENDIX
ABBREVIATIONS
AHU
AMP
CFM
G.I.
FPM
MOC
db
RH
SOP
T.F
PUF
HEPA
DOP
Sq.ft
Form No: APL/QA/F012-00/06-2001
Air Handling Unit

Ampere
Cubic Feet per Minute
Galvanized Iron
Feet Per Minute
Material Of Construction
Decibels
Micron
Relative Humidity
Standard Operating Procedure
Treated Fire resistance
Poly Urethane Foam
High Efficiency Particulate Air
Di Octyl Phthalate
Square feet

Ahu 1a

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Ahu 1a

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PERFORMANCE QUALIFICATION

Equipment Name AIR HANDLING UNIT

Equipment Number AHU 1A

01.0 PROTOCOL APPROVAL..............................................................................................2

08.0 DEFICIENCY AND CORRECTIVE ACTION REPORT............................................56

Form No: APL/QA/F012-00/06-2001

Equipment Number AHU 1A

Preparation of this qualification plan is the responsibility of Validation Coordinator of the

Form No: APL/QA/F012-00/06-2001

Equipment Number AHU 1A

The scope of this protocol is to establish final

Standard Operating Procedures

Standard Cleaning Procedures

Critical process control checkpoints,

Critical Process control points,

Alert and action limits

Form No: APL/QA/F012-00/06-2001

Equipment Number AHU 1A

Form No: APL/QA/F012-00/06-2001

Equipment Number AHU 1A

EQUIPMENT / SYSTEM DESCRIPTION

Supply Air Plenum

Volume and Fire Control Dampers

Supply and Return Air grills / diffusers

Return Air Plenum

10. Centrifugal Blower (Return)

The Pre-filter is made of Synthetic non-woven media supporting by HDPE having

The Microvee Filter is made of Synthetic non-woven media supporting by HDPE

Form No: APL/QA/F012-00/06-2001

Equipment Number AHU 1A

EQUIPMENT / SYSTEM DESCRIPTION (Continued)

Form No: APL/QA/F012-00/06-2001

Intermediate Reactors area

Equipment Number AHU 1A

ACCEPTANCE AND REVALIDATION CRITERIA

Efficiency of HEPA filter should not be less than 99.97%.

The flow direction should be from positive Pressure to negative pressure.

06.2.1 Whenever a major changes have been done in the system.

Air Velocity & Air Changes

Form No: APL/QA/F012-00/06-2001

Equipment Number AHU 1A

AIR VELOCITY AND AIR CHANGES TEST

Equipment and Instrument

These tests are executed in every room where an diffuser is installed.

Keep the Anemometer range as 0 - 1500 FPM.

Allow no object within 10 ft of the Anemometer. Minimize the no of people during

Measurement should be taken for a minimum of 15 seconds.

Calculate the CFM and Air changes.

Form No: APL/QA/F012-00/06-2001

Equipment Number AHU 1A

All Damper positions are marked permanently after air balancing.

1. Total Air Flow CFM

Form No: APL/QA/F012-00/06-2001

Where, FPM is Feet per minute

Equipment Number AHU 1A

AIR VELOCITY AND AIR CHANGES TEST RESULTS

Form No: APL/QA/F012-00/06-2001

Equipment Number AHU 1A

Form No: APL/QA/F012-00/06-2001

Equipment Number AHU 1A

Form No: APL/QA/F012-00/06-2001

Equipment Number AHU 1A

Form No: APL/QA/F012-00/06-2001