OPERATION QUALIFICATION

SYSTEM NAME AIR HANDLING UNIT PAGE NO.

SYSTEM NUMBER AHU-09 1 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

1.0 PROTOCOL APPROVAL SHEET

The signatures below indicate of this protocol and its data collection forms certify that it may
be executed. This approval is the joint responsibility of the listed functional areas of .

PROTOCOL DEVELOPMENT

Name Designation Signature Date

Project Engg.

PROTOCOL REVIEW

Name Designation Signature Date

Project Manager

Engineer

Manager-FDD

PROTOCOL APPROVAL

Name Designation Signature Date

Sr. Manager - Technical

Sr. Executive - QA

Corp. Engg.
 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 2 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

TABLE OF CONTENTS

SR. NO CONTENTS PAGE NO

1.0 PROTOCOL APPROVAL SHEET 1

2.0 PURPOSE, SCOPE, INTENDED USE, LOCATION, REFERENCE & 3

RESPONSIBILITY
3.0 OPERATION QUALIFICATION PROCEDURE 4
4.0 HVAC FUNCTIONAL TEST VERIFICATION 5
4.1 VERIFICATION OF HVAC START UP 5
4.2 VERIFICATION OF MOTOR BLOWER ASSEMBLY OPERATION 6
4.3 VERIFICATION OF PUSH BUTTONS OPERATION 7
4.4 AHU BLOWDOWN PROCEDURE & TEST REPORT 8
4.5 NEW FILTER INSTALLATION SEQUENCE 9
4.6 VERIFICATION OF COOLING & HEATING SYSTEMS 10
4.7 VERIFICATION OF MAGNEHELIC GAUGES OPERATION 12
4.8 VERIFICATION OF DIFFERENTIAL PRESSURE INDICATOR OPERATION 13
4.9 VERIFICATION OF AHU SAFETY LIMIT SWITCH OPERATION 14
4.10 AHU COMMISSIONING REPORT 15
4.11 DEHUMIDIFIER COMMISSIONING REPORT 16
5.0 TESTING/MEASURING INSTRUMENTS CALIBRATION STATUS 17
5.0 OBSERVED DEVIATION 18
6.0 RECOMENDATIONS 19
7.0 CONCLUSION 20
 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 3 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

2.0 PURPOSE, SCOPE, INTENDED USE, LOCATION, REFERENCE & RESPONSIBILITY

2.1 PURPOSE:
To provide the documentary evidences that the HVAC system (AHU-09) of Manufacturing
Area is Operating as per set design parameters
2.2 SCOPE
This qualification protocol is applicable to AHU-09 which is catering clean and conditioned
air to following rooms of Manufacturing Area.

False Ceiling Height

Room Name Room Area in Ft2 Room Volume in Ft3
Ft
GRANULATION 273.44 8.69 2377

MATERIAL IN 50.32 7.87 396

MATERIAL OUT 56.51 7.87 445

AIR LOCK 43.86 7.87 345

2.3 INTENDED USE:

 To supply the required air quantity and quality to various rooms of Manufacturing
Area.
 To maintain the temperature and humidity of room as per design specification.
 To provide differential air pressure of the room.
2.4 LOCATION
2.5 REFERENCE
Design Qualification, Installation Qualification

2.6 RESPONSIBILITY:

 To prepare qualification protocol.

 To submit qualification protocol to for approval.
 To record the observation along with during execution of the protocol.
 To submit final qualification report to for approval.
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SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 4 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

QUALITY ASSURANCE
 To review and approval of qualification protocol and report.

ENGINEERING
 To review the Qualification protocol and report.
 To provide utilities and supportive services for qualification.
 To assist QA/Production while qualification study.

TECHNICAL SERVICES.
 To review and approval of qualification protocol and report.

3.0 OPERATION QUALIFICATION PROCEDURE:

 Operate the AHU as per predefined procedure.

 Record the observation in Table provided against operational parameters.
 Document initial and date after each observation in respective column
 In case of any deviation document in ‘Remark’ column and inform to department head
and quality head for necessary action.
 Document the deviation details in Observed deviation section.
 The Quality head and department head of will decide whether deviation is acceptable
or not.
 If deviation is acceptable and it does not have impact on operation, initiate for
performance qualification.
 If deviation is not acceptable inform to Manufacturer for necessary action for
attending problems to complete Operational Qualification.
 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 5 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

4.0 HVAC FUNCTIONAL TEST VERIFICATION

4.1 VERIFICATION OF HVAC STARTS UP:

Sr. Observations &

Function Parameter Acceptance Criteria Remarks
No. Result
1. Start the motor of the fan The motor should start
after switching “ON” from operating.
Starter.
2. Switch “OFF” the fan motor The motor should stop.
from the Starter.
3. Start the Dehumidifier The DHU should start
after switching “ON” from operating.
DHU Starter Panel.
4. Switch “OFF” the The DHU should stop.
Dehumidifier from the DHU
Starter Panel.
5. Check the functioning of The damper should open
the damper on the return and close when so done.
air inlet/ supply air outlet/
Fresh air inlet.
6. Check for the functioning The butterfly valve should
of the pressure Gauges and open and close when so
butterfly valves on the Inlet operated with the
and Outlet of the chilled pressure Gauge showing
water line. the pressure respective to
the position of the valve.
7. By pass valve at chilled / The bypass valve should
valve functioning. function as and when
operated.

Comments:..................................................................................................................
..........................................................................................................................

Installed By : Installation Inspected By : Installation Approved By :

 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 6 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

Name Name Name

4.2 VERIFICATION OF MOTOR BLOWER ASSEMBLY OPERATION:
Instructions: Check the motor blower assembly for proper fitment on base frame, motor shaft
rotation, blower rotation, belt tension between motor and blower pulley. Verify the motor RPM by
using calibrated Tachometer. Check the motor current by using calibrated Multi meter. Verify the
performance of motor by running it continuously for 30 minutes. Record any unusual observations in
Comments/Inference.
Designed acceptance
Activity Observations Remarks
criteria
Check the Supply Blower Blower and Motor should be
and Motor assembly for properly fitted on base
proper fitment on base frame and tightened with
frame. bolts and nuts.
Check the motor shaft Motor shaft should rotate
rotation, manually. smoothly when rotated
manually.
Check the Blower Blower should rotate
rotation, manually. smoothly when rotated
manually.
Check the supply air There should not be any
blower for any abnormal abnormal sound in the supply
sound air blower.
Check the direction of Blower should rotate as per
the rotation of the the arrow mark indicated on
blower. the blower.
Check the Blower RPM
Blower RPM should be 2874
by using calibrated
 10%
Tachometer.

Comments:..................................................................................................................
.................................................................................................................................
......................................................................................................

Operated By : Operations Inspected By : Operations Approved By :

 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 7 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

Name Name Name

4.3 VERIFICATION OF PUSH BUTTON OPERATION:

Observations &
Sr. No. Function Parameter Acceptance Criteria Remarks
Result
1. Keep The Control AHU Should be switched on
Switch in Manual Mode
in AHU Starter Panel
Press the Green Push
Button located in Clean
Corridor to start the
AHU
2. Press the Red Push The AHU should Switch Off
Button to switch off the
AHU
3. Keep The Control AHU should not switched
Switch in Auto Mode in on
AHU Starter Panel,
Press the Green Push
Button to start the AHU
4. Keep The Control AHU should not be switched
Switch in Auto Mode in off
AHU Starter Panel and
keep the AHU in
running condition
Press the Red Push
Button to switch off the
AHU

Comments:..................................................................................................................
.................................................................................................................................
.........................................................................................................

Tested By : Inspected By : Approved By :

Name Name Name

 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 8 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

4.4 AHU BLOWDOWN PROCEDURE:

1.0 Purpose:
Steps to be followed to blow down the contaminants, dusts and other unwanted items
stored in ducts or inside the clean rooms during HVAC/Clean room installation after
successful completion of installation
2.0 Testing Procedure:
 The motor is set at the design speed and direction of rotation is ok.
 Install blow down filter (to avoid larger size particles) instead of installing new filters to
avoid dust accumulation in new filters and may have chance of choking during
commissioning stage itself.
 Check all dampers (AHU, riser & terminals) are open & working properly.
 Note down the current and frequency’s at the design RPM.
 AHU to be operated continuously for minimum of 72 hours and cleaning of area where the
AHU is catering air supply to be carried out in parallel to blow down all unwanted
materials, dust, welding purs, insulation cut pieces etc.
 Check for any abnormal sound, misalignment of blower and motor, proper belt tension
during operation of AHU.
 Procedure to be followed again for another 72 hours if the accumulation of dusts and
unwanted materials not removed from the area satisfactorily.
Note: Installation of new Pre Filters, Fine Filters, HEPA Filters to be carried out stage by stage
(as shown in next page) only after satisfactory completion of blow down procedure,
cleaning at clean room area and service floor where AHU is located.

AHU BLOWDOWN REPORT

Sr. No. AHU Number Observation Done By/ Date Checked By/ Date

1. AHU-09
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SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 9 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

4.5 NEW FILTER INSTALLATION SEQUENCE:

Sr. From To
OPERATION OBSERVATION
No. Time Date Time Date
1. Installation of Pre filters and
operation of AHU for 24 hrs.

2. installation of Fine filters and

run for 24 Hours

Removal, cleaning and

3. reinstallation of both Pre
filters & Fine filters &
installation Plenum HEPA
Filters. And Run for 24 Hours

Comments:...........................................................................................................
.........................................................................................................................
.........................................................................................................................
.........................................................................................................................
.........................................................................................................................
.........................................................................................................................
.........................................................................................................................
.........................................................................................................................

Performed By : Inspected By : Approved By :

Name:
Name Name
 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 10 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

4.6 VERIFICATION OF OPERATION OF COOLING & HEATING SYSTEMS:

3 WAY MODULATING VALVE:
Instructions: Verify 3 Way modulating valves located on chilled water loops for proper functioning.
Record any unusual observations in Comments/Inference. Record any unusual observations.

Method acceptance criteria Activity Observations Remarks

Change and reduce the set Three way valve Set the temp.
point of Temperature and RH actuator should 24ºC
Sensor, installed in the operate the valve to
Return Air duct, at 18ºC increase the flow of Reduce the
temperature. chilled water temp. at 18ºC
Note: 1. Set point for through the coil
controlling chilled water
valve actuator is 24ºC Restore the
temp. 24ºC
2. Restore the original
setting after study.
Change and increase the set Three way valve Set the temp.
point of Temperature and RH actuator should 24ºC
Sensor, installed in the operate the valve to
Return Air duct, at 28ºC reduce the flow of Increase the
temperature. chilled water temp. at 28ºC
Note: 1. Set point for through the coil
controlling chilled water
valve actuator is 22ºC Restore the
temp. 24ºC
2. Restore the original
setting after study.
Check for the leakage of There should not
Check the
chilled water cooling coil be any leakage.
leakage
visually.

Comments:...........................................................................................................
.........................................................................................................................

Operated By : Inspected By : Approved By :

Name Name Name

 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 11 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

4.6 VERIFICATION OF OPERATION OF COOLING & HEATING SYSTEMS:

DEHUMIDIFIER:
Instructions: Verify Strip Heater installed in the AHU for proper functioning. Record any unusual observations in
Comments/Inference. Record any unusual observations.

Method acceptance criteria Activity Observations Remarks

Change and increase the set The Dehumidifier Set the RH to
point of RH Sensor, should switch on 40%
installed in the Return Air when RH in return
duct, at 55%. air RH reaches 45% Increase the RH
Note: 1. Set point Range at 55%
for controlling Dehumidifier
is 40+5%
Restore the RH
2. Restore the original at 40%
setting after study.

Change and decrease the The Dehumidifier Set the RH to

set point of RH Sensor, should switch off 40%
installed in the Return Air when return air RH
duct, at 25% temperature. reaches 35% Decrease the
Note: 1. Set point for RH at 25%
controlling Dehumidifier is
40+5%
Restore the RH
2. Restore the original at 40%
setting after study.

Comments:...........................................................................................................
.........................................................................................................................
.........................................................................................................................

Operated By : Inspected By : Approved By :

Name Name Name

 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 12 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

4.7 VERIFICATION OF MAGNEHALIC GAUGE OPERATION:

MAGNEHELIC GAUGES FOR PRE, FINE & HEPA FILTERS:

Sr. Observation
No Function Parameter Acceptance Criteria &Results Remarks
.
1. Check the zero Setting of the The Magnehelic
Magnehelic Gauge by Gauge should
disconnecting Tube indicate Zero setting.
connections on both ends.
2. Verify the Magnehelic Gauge The Magnehelic Measured DP
function when AHU is “ON” Gauge should across Pre Filter:
indicate the pressure
differential across ………………………
filter.
Measured DP
across Fine
Filter:

………………………
Verify the Magnehelic Gauge The Magnehelic
function when AHU is “OFF” Gauge readings
should come back to
Zero.

Comments:...........................................................................................................
.........................................................................................................................
.........................................................................................................................

Tested By : Inspected By : Approved By :

Name Name Name

4.8 VERIFICATION OF DIFFERENTIAL PRESSURE INDICATOR OPERATION:

 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 13 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

Sr. Function Observation &Results

Acceptance Criteria Remarks
No Parameter
1. Check the zero The DP Indicator
Setting of the should indicate Zero
Indicator by setting.
keeping the door
open of the room
which DP to be
measured.
2. Verify the DP The DP indicator Measured DP
Indicator function. should indicate the Corridor-4 to Material In:
pressure differential
across Rooms
Corridor-4 to Material Out:

Corridor-4 to Airlock:

Air Lock- Granulation:

Comments:...........................................................................................................
.........................................................................................................................
.........................................................................................................................

Tested By : Inspected By : Approved By :

Name Name Name

4.9 VERIFICATION OF AHU SAFETY LIMIT SWITCH OPERATION:

 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 14 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

Sr. Observation
Function Parameter Acceptance Criteria Remarks
No. &Results
1. Keep Selector Switch in The motor should
Manual Mode Function, Keep stop as soon as the
The AHU in “ON” Condition, access door lost the
Open Blower Motor Access contact of limit
Door when AHU in Running switch, Green Push
Condition Button Indicator
should glow in
starter panel
2. Close the AHU Motor Blower The AHU Should start
Access Door, Switch on the again
AHU by pushing RED Push
Button
Keep Selector Switch in Auto The motor should
Mode Function, Keep The AHU stop as soon as the
in “ON” Condition, Open access door lost the
Blower Motor Access Door contact of limit
when AHU in Running switch, Green Push
Condition Button Indicator
should glow in
starter panel
Close the AHU Motor Blower The AHU Should start
Access Door, again automatically

Comments:...........................................................................................................
.........................................................................................................................
.........................................................................................................................

Tested By : Inspected By : Approved By :

Name Name Name

4.10 AIR HANDLING UNIT COMMISSIONING REPORT:

 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 15 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

Sl. No Attributes Units Design Actual Remarks

1 Total Supply Air Quantity CFM

2 Fresh Air Quantity CFM

3 Static Pressure Mm wg

4 Fan Speed RPM

5 Motor Speed RPM

6 Motor Current Amps Y

RY

7 Line Voltage Volts RB

YB

Comments:.............................................................................
...........................................................................................
...........................................................................................
..........................................................................................
Tested By : Inspected By : Approved By :
 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 16 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

Name Name Name

4.11 DEHUMIDIFIER COMMISSIONING REPORT:

Sl. No Attributes Units Design Actual Remarks

1 Pre Cooling Fresh Air Qty CFM
Fresh Air Dry Bulb
2 0
F
temperature
Fresh Air Wet Bulb 0
3 F
temperature
4 Process Air in Qty CFM
Process Air In Dry bulb 0
5 F
temperature

6 Process Air In Wet bulb 0

F
temperature
No of Grains/
7 Specific Humidity
8 Process Air Out Qty CFM
Process Air out Dry bulb 0
9 F
temperature
Process Air out Wet bulb
10 0
F
temperature
11 Specific Humidity No of Grains/

R
12 Motor Current Amps Y
B
RY
13 Line Voltage Volts RB
YB

Comments:.............................................................................
...........................................................................................
...........................................................................................
..........................................................................................
Tested By : Inspected By : Approved By :
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SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 17 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

Name
Name Name

5.0 TESTING/MEASURING INSTRUMENTS CALIBRATION STATUS

Calibration Calibration
Instrument Name Serial No Calibration Report Ref
Done on Due on

Inspected By: - Approved By: -

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SYSTEM NAME AIR HANDLING UNIT PAGE NO.
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DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

6.0 OBSERVED DEVIATIONS:

Details of Deviations :

Investigation :

Corrective Action :

Acceptable : Yes / No

Deviation Approved By / Date :

Name : Sign : Name : Sign :

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DOCUMENT NO /NPL/OQ/S-02 REV NO: R0

7.0 RECOMMENDATIONS:
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SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 20 of 21
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8.0 CONCLUSION:

Concluded by:

: (Engineering):

Date: Date :

(Q.A) :

Date :
 OPERATION QUALIFICATION
SYSTEM NAME AIR HANDLING UNIT PAGE NO.
SYSTEM NUMBER AHU-09 21 of 21
DOCUMENT NO /NPL/OQ/S-02 REV NO: R0