Ahu - PQ-14.10.10

QUALIFICATION PROTOCOL
Equipment
Equipment Name AIR HANDLING UNIT AHU -20
Number
Protocol Number CDP/QP/AHU-20/01 Effective Date Jun. 2009
Page No. 1 of 25
Equipment
Number
TABLE OF CONTENTS
01.0 PROTOCOL APPROVAL..................................................................3
02.0 OBJECTIVE...................................................................................4
03.0 SCOPE..........................................................................................4
04.0 EXECUTION TEAM.........................................................................5
05.0 EQUIPMENT / SYSTEM DESCRIPTION..........................................5
06.0 ACCEPTANCE AND REVALIDATION CRITERIA...............................8
07.0 TEST PROCEDURE.........................................................................9
08.0 DEFICIENCY AND CORRECTIVE ACTION REPORT.......................20
09.0 SUMMARY AND EVALUATION OF RESULTS.................................22
10.0 APPENDIX..................................................................................24
11.0 FINAL REPORT APPROVAL..........................................................25
Page No. 2 of 25
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Number
01.0 PROTOCOL APPROVAL
01.1 Protocol Prepared by
Preparation of this qualification plan is the responsibility of Validation Co-

coordinator.
NAME DESIGNATION SIGNATURE

MAINTENANCE
ENGINEER
01.2 Protocol Checked by
Checking of this qualification plan is the responsibility of Validation Task Force

DY. MANAGER
Mr. M. CHELLAPPA
-PRODUCTION
01.3 Protocol Approved by
Pre approval of this qualification plan is the responsibility of the Head QA
MANAGER -QA
Page No. 3 of 25
Equipment
Number
02.0 OBJECTIVE
The objective of this protocol is to provide an outline for the Verification
of Performance of Air Handling Unit 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
Page No. 4 of 25
Equipment
Number
4.0 EXECUTION TEAM
Name Responsibility Designation Signature

To provide adequate
MAINTENANCE
manpower and
ENGINEER
supervise the execution
activities
To execute the protocol
and to provide sufficient MANAGERPROD
manpower from M/s UCITON
CRP for execution.
To provide protocols/
datasheets and to
EXECUTIVE QA
review the executed
Protocols.
05.0 EQUIPMENT / SYSTEM DESCRIPTION
This AHU-20 unit is designed to handle the Granulation-I. Air handling

unit is a close system, which re-circulates the air free from particulate
matter to different areas.
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.
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. In case of fire
intrinsic energy of the folded blades shall be utilized to close the
openings. The thrust from closing of dampers shall operate a limit switch
mounted in the bottom of fire damper within the duct. Closing of this
limit switch shall shut off the power supply to the AHU-20 where by
stopping the air flow unstintingly.
Capacity
Page No. 5 of 25
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The AHU-20 has a capacity of 6250 CFM supplies to the granulation-I.

This AHU-20 covers Ground floor of process areas
S.No Floor Area Class

1. Ground Granulation-I 1,00,000
05.0 EQUIPMENT / SYSTEM DESCRIPTION

The HVAC system consists of:
i. Air Circulation System
ii. Air Cooling & Heating System
iii. Air Distribution System
iv. Air Filtration System
FUNCTION: The system is designed to circulate the air in the area after
passing it over cooling and heating coils to maintain the required
environmental conditions and passing it through the series of filters to
maintain desired cleanliness level in the area. The air in-take and out-take of
the system is designed to maintain certain degree of pressure gradient in the
area as per the requirement. The major components of the air-handling unit
are briefly described as below:
Page No. 6 of 25
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5.1 AIR CIRCULATION SYSTEM

5.1.1 Supply Blower: Supply blowers are provided in the unit to supply
air in the working area. This blower is belt driven by a motor. The
blower takes the air from the atmosphere and / or from the rooms
as return air and delivers it to the working areas through air
distribution network.
5.1.2 Return Blower: AHU-20 is equipped with Return blowers to pick
air from the working area. This blower is belt driven by a motor.
The blower takes the air from the rooms as return air and delivers
it in Mixing Chamber to get it mixed with fresh air. During de-
fumigation, this blower is to be used at exhaust blower.
5.2 AIR COOLING AND HEATING SYSTEM
5.2.1 Cooling Coil: Chilled water produced by a water chilling plant is to
be circulated into the chilled water coils of air handling units. Air
passes through the coil and in turn gets cooled. Cooling coil is
placed after the pre filters in coil section of AHU-20
5.2.2 Heating Coil: Hot water produced by a hot water tank is to be
circulated into the hot water coils of air handling units. Air passes
through the coil and in turn gets hot. Heating coil is placed after
the cooling coil in coil section of AHU-20
5.3 AIR DISTRIBUTION SYSTEM
5.3.1 Air Distribution Network: An air distribution network is provided
to supply the air, delivered by the blowers, into the working areas.
By using the same network, return air flows back to the air
handling unit to maintain certain pressure gradient and other
parameters like temperature & RH.
5.4 AIR FILTRATION SYSTEM
Page No. 7 of 25
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5.4.1 Fresh Air Filters: Pre filters having filtration efficiency upto 90%
down to 10 are provided in the Fresh air suction to filter out
heavy dust particles from the fresh air and to avoid chocking of
cooling and heating coils.
5.4.2 Secondary Filters: Fine filters having filtration efficiency up to

99% down to 5 are provided after the cooling and heating coils to
remove fine particles up to 5 from the treated air.
06.0 ACCEPTANCE AND REVALIDATION CRITERIA
06.1 ACCEPTANCE CRITERIA
06.1.1 The air velocity and air changes should be less than the design criteria
06.1.2 The particle count of the area should not be more than 1,00,000 (
0.3 size) and 700 ( 5.0 size) per cubic feet under At Rest
Condition.
06.1.3 Temperature of the all areas should be 25 2OC and Relative Humidity
Between 50 5%.
Page No. 8 of 25
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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) Equipment and Instrument

Anemometer Make -Millipore Model MP - 212
c) Procedure
07.1.1 These tests are executed in every room where an diffuser / grill 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 5 tests spots. Measure the air
velocity at 4 corners of the diffuser/grill and one at the center.
07.1.5 Allow no object within 10 ft of the Anemometer. Minimize the no of

people during at rest testing.
07.1.6 Reading should be taken for a minimum of 15 seconds.
07.1.7 Calculate the CFM and Air changes.
NOTE
5% variation of actual CFM with respect to the Design CFM is
acceptable at each outlet. However the Total CFM in a room
should not be less than the Design CFM.
Page No. 9 of 25
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All Damper positions are marked permanently after air

balancing.
V1 V2
V3 V4
Calculations
1. Total Air Flow CFM
Air Velocity in FPM x Area of Diffuser/GrillWhere, FPM is Feet per minute

CFM is Cubic Feet per minute
2. Air Changes
Total CFM x Time (60 minutes)

__________________________
Volume of Room (ft3)
Page No. 10 of
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d) TEST RESULTS
i) ROOM DETAILS :
Room Name Length Width Height Area

(Cu. ft)
Granulation - I
25 25 10 6250
e) Acceptance Criteria
5% of variation on actual CFM with respect to the design CFM is

acceptable at each outlet. However the total CFM in a room should not
be less than the desired CFM.
f) Conclusion
The Air Velocity (CFM) and air changes per hour (ACPH) of the AHU-20
Complies/ Not complies with the acceptance criteria.
Page No. 11 of
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07.2 FILTER INTEGRITY TEST
a) Purpose
To ensure that the 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.
c) 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 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 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 filter
grill, and start scanning the filter face area and fitment of filter with
frame.
Ensure that the scanning speed does not exceed 10 ft /min

velocity.
07.2.9 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.
Page No. 12 of
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07.3 TEMPERATURE, RELATIVE HUMIDITY MONITORING
a) Purpose
To demonstrate that the Air Handling Unit is capable of achieving the

desired set of environmental conditions (Temperature, RH in the
subjected area / room.)
c) 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 for 72 hours at the time
interval of 1 hour.
07.3.5 This test should be carried out at rest (Static) and In operation
(dynamic) conditions.
7.3.6 Plot the trend charts for the studied parameters*.
d) Test Results
Record the Temperature and Relative Humidity in Table: 1 At Rest

Condition.
Record the Temperature and Relative Humidity in Table: 2In

Operation Condition.
Table No: 1 Environmental Control Recording Chart for At rest

Condition
Page No. 13 of
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Equipment
Number
Granulation I
Time (Hrs)
Temp. (C) RH (%)
Table No: 2 Environmental Control Recording Chart for At rest

Condition
Time Granulation I
(Hrs) Temp. (C) RH (%)
Page No. 14 of
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d) Acceptance Criteria
Temperature : 25 2C
Relative Humidity : 50 5%
e) Conclusion
Temperature and relative humidity monitoring of GranulationI AHU-20
was (At rest condition) Complies / Not Complies with acceptance
criteria.
Page No. 15 of
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Number
Table No: 3 Environmental Control Recording Chart for In

Operation Condition
Time Granulation I
(Hrs) Temp. (C)
RH (%)
Table No: 4 Environmental Control Recording Chart for In

Operation Condition
Granulation I
Page No. 16 of
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Number
Time
Temp. (C)
(Hrs)
RH (%)
Page No. 17 of
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Temperature : 25 2C
Relative Humidity : 50 5%
e) Conclusion
Temperature and relative humidity monitoring of Granulation-I AHU-20
was (At rest condition) Complies/ Not Complies with acceptance
criteria.
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.
Class 100 000

0.3 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.
Page No. 18 of
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08.0 DEFICIENCY AND CORRECTIVE ACTION REPORT
08.1 Description of deficiency and date observed
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08.2 Person responsible for corrective action and date assigned
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Page No. 19 of
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08.3 Corrective actions taken and date conducted
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SIGNATURES
Conducted By: Date:
Approved By: Date:
Page No. 20 of
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09.0 SUMMARY AND EVALUATION OF RESULTS
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Page No. 21 of
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09.1 FINAL REPORT
Page No. 22 of
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10.0 APPENDIX
ABBREVIATIONS
AHU Air Handling Unit
AMP Ampere
CFM Cubic Feet per Minute
Db Decibels
DOP Di Octyl Pthylate
DP Differential Pressure
FPM Feet Per Minute
G.I. Galvanized Iron
HVAC Heating Ventilation and Air Conditioning
MOC Material Of Construction
PUF Poly Urethane Foam
RH Relative Humidity
SOP Standard Operating Procedure
Sq.ft Square feet
UCL Upper Confidence Limit
URS User Requirement Specification
Micron
Page No. 23 of
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Number
11.0 FINAL REPORT APPROVAL
11.1 Prepared by
The Signature indicates that the qualification protocol was executed and all
tests cases and discrepancies were properly documented.
NAME DESIGNATION SIGNATURE DATE

MAINTENANCE
ENGINEER
11.2 Checked by
The Signature indicates that qualification, documentation and reports have

been reviewed and they meet the requirements specified.
EXECUTIVE- QUALITY
ASSURANCE
MANAGER-
PRODUCTION
11.3 Approved by
The Signature indicates that the results have been reviewed and is in
agreement with those results and their conclusions.
MANAGER- QA
Now the equipment is READY FOR ROUTINE USE.
Page No. 24 of
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QUALIFICATION PROTOCOL

01.0 PROTOCOL APPROVAL..................................................................3

04.0 EXECUTION TEAM.........................................................................5

05.0 EQUIPMENT / SYSTEM DESCRIPTION..........................................5

06.0 ACCEPTANCE AND REVALIDATION CRITERIA...............................8

07.0 TEST PROCEDURE.........................................................................9

08.0 DEFICIENCY AND CORRECTIVE ACTION REPORT.......................20

09.0 SUMMARY AND EVALUATION OF RESULTS.................................22

11.0 FINAL REPORT APPROVAL..........................................................25

01.0 PROTOCOL APPROVAL

01.1 Protocol Prepared by

Preparation of this qualification plan is the responsibility of Validation Co-

NAME DESIGNATION SIGNATURE

01.2 Protocol Checked by

Checking of this qualification plan is the responsibility of Validation Task Force

NAME DESIGNATION SIGNATURE

01.3 Protocol Approved by

Pre approval of this qualification plan is the responsibility of the Head QA

NAME DESIGNATION SIGNATURE

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

4.0 EXECUTION TEAM

Name Responsibility Designation Signature

05.0 EQUIPMENT / SYSTEM DESCRIPTION

This AHU-20 unit is designed to handle the Granulation-I. Air handling

Dampers (Volume and Fire Control)

The AHU-20 has a capacity of 6250 CFM supplies to the granulation-I.

S.No Floor Area Class

05.0 EQUIPMENT / SYSTEM DESCRIPTION

5.1 AIR CIRCULATION SYSTEM

5.4.2 Secondary Filters: Fine filters having filtration efficiency up to

06.0 ACCEPTANCE AND REVALIDATION CRITERIA

06.1 ACCEPTANCE CRITERIA

07.0 TEST PROCEDURE

07.1 AIR VELOCITY AND AIR CHANGES TEST

To demonstrate that the air system is balanced and capable of delivering

b) Equipment and Instrument

07.1.2 Keep the Anemometer range as 0 - 1500 FPM.

07.1.5 Allow no object within 10 ft of the Anemometer. Minimize the no of

07.1.6 Reading should be taken for a minimum of 15 seconds.

07.1.7 Calculate the CFM and Air changes.

All Damper positions are marked permanently after air

1. Total Air Flow CFM

Air Velocity in FPM x Area of Diffuser/GrillWhere, FPM is Feet per minute

Total CFM x Time (60 minutes)

Room Name Length Width Height Area

5% of variation on actual CFM with respect to the design CFM is

07.2 FILTER INTEGRITY TEST

Ensure that the scanning speed does not exceed 10 ft /min

07.3 TEMPERATURE, RELATIVE HUMIDITY MONITORING

To demonstrate that the Air Handling Unit is capable of achieving the

07.3.2 Air conditioning system should be in operation for at least 24 hour

7.3.6 Plot the trend charts for the studied parameters*.

Record the Temperature and Relative Humidity in Table: 1 At Rest