Ahu Operation Qualification Document
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OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 1 of 21 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 Sr. Manager - Technical
Sr. Executive - QA Corp. Engg.
Signature
Date
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 2 of 21 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 & RESPONSIBILITY
3
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 SYSTEM NUMBER DOCUMENT NO
PAGE NO. 3 of 21 REV NO: R0
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
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. Room Area in Ft2
False Ceiling Height Ft
Room Volume in Ft3
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
Room Name
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.
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 4 of 21 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. 3.0
To review and approval of qualification protocol and report. 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 SYSTEM NUMBER DOCUMENT NO
4.0
HVAC FUNCTIONAL TEST VERIFICATION
4.1
VERIFICATION OF HVAC STARTS UP:
Sr. No.
Function Parameter
PAGE NO. 5 of 21 REV NO: R0
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
Acceptance Criteria
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 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 of the pressure butterfly valves and Outlet of water line.
7.
By pass valve at chilled / The bypass valve should valve functioning. function as and when operated.
functioning Gauges and on the Inlet the chilled
should
Observations & Result
Remarks
start
The butterfly valve should open and close when so operated with the pressure Gauge showing the pressure respective to the position of the valve.
Comments:.................................................................................................................. .......................................................................................................................... Installed By :
Installation Inspected By :
Installation Approved By :
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 6 of 21 REV NO: R0
Name Name 4.2 VERIFICATION OF MOTOR BLOWER ASSEMBLY OPERATION:
Name
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. Activity
Designed acceptance criteria
Check the Supply Blower and Motor assembly for proper fitment on base frame.
Blower and Motor should be properly fitted on base frame and tightened with bolts and nuts.
Check the motor shaft rotation, manually.
Motor shaft should rotate smoothly when rotated manually.
Check the Blower rotation, manually.
Blower should rotate smoothly when rotated manually.
Check the supply air blower for any abnormal sound
There should not be any abnormal sound in the supply air blower.
Check the direction of the rotation of the blower.
Blower should rotate as per the arrow mark indicated on the blower.
Check the Blower RPM by using calibrated Tachometer.
Blower RPM should be 2874 10%
Observations
Remarks
Comments:.................................................................................................................. ................................................................................................................................. ...................................................................................................... Operated By :
Operations Inspected By :
Operations Approved By :
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
Name Name 4.3 VERIFICATION OF PUSH BUTTON OPERATION: Sr. No.
Function Parameter
Acceptance Criteria
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
PAGE NO. 7 of 21 REV NO: R0 Name
Observations & Result
Remarks
Comments:.................................................................................................................. ................................................................................................................................. ......................................................................................................... Tested By :
Inspected By :
Approved By :
Name
Name
Name
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
4.4
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 8 of 21 REV NO: R0
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
1.
AHU-09
Observation
Done By/ Date
Checked By/ Date
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 9 of 21 REV NO: R0
4.5 NEW FILTER INSTALLATION SEQUENCE: Sr. No.
From
OPERATION
Time
1.
Installation of Pre filters and operation of AHU for 24 hrs.
2.
installation of Fine filters and run for 24 Hours
3.
To Date
Time
Date
OBSERVATION
Removal, cleaning and reinstallation of both Pre filters & Fine filters & installation Plenum HEPA Filters. And Run for 24 Hours
Comments:........................................................................................................... ......................................................................................................................... ......................................................................................................................... ......................................................................................................................... ......................................................................................................................... ......................................................................................................................... ......................................................................................................................... .........................................................................................................................
Performed By :
Name:
Inspected By :
Approved By :
Name
Name
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 10 of 21 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
Change and reduce the set point of Temperature and RH Sensor, installed in the Return Air duct, at 18ºC temperature. Note: 1. Set point for controlling chilled water valve actuator is 24ºC 2. Restore the original setting after study.
Three way valve Set the temp. actuator should 24ºC operate the valve to increase the flow of Reduce the chilled water temp. at 18ºC through the coil
Change and increase the set point of Temperature and RH Sensor, installed in the Return Air duct, at 28ºC temperature. Note: 1. Set point for controlling chilled water valve actuator is 22ºC 2. Restore the original setting after study.
Three way valve Set the temp. actuator should 24ºC operate the valve to reduce the flow of Increase the chilled water temp. at 28ºC through the coil
Check for the leakage of chilled water cooling coil visually.
Observations
Remarks
Restore the temp. 24ºC
Restore the temp. 24ºC There should not be any leakage.
Check the leakage
Comments:........................................................................................................... ......................................................................................................................... Operated By :
Inspected By :
Approved By :
Name
Name
Name
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 11 of 21 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
Change and increase the set point of RH Sensor, installed in the Return Air duct, at 55%. Note: 1. Set point Range for controlling Dehumidifier is 40+5% 2. Restore the original setting after study.
The Dehumidifier should switch on when RH in return air RH reaches 45%
Change and decrease the set point of RH Sensor, installed in the Return Air duct, at 25% temperature. Note: 1. Set point for controlling Dehumidifier is 40+5% 2. Restore the original setting after study.
The Dehumidifier should switch off when return air RH reaches 35%
Activity
Observations
Remarks
Set the RH to 40% Increase the RH at 55% Restore the RH at 40% Set the RH to 40% Decrease the RH at 25% Restore the RH at 40%
Comments:........................................................................................................... ......................................................................................................................... ......................................................................................................................... Operated By :
Inspected By :
Approved By :
Name
Name
Name
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 12 of 21 REV NO: R0
4.7 VERIFICATION OF MAGNEHALIC GAUGE OPERATION: MAGNEHELIC GAUGES FOR PRE, FINE & HEPA FILTERS: Sr. No . 1.
2.
Function Parameter
Acceptance Criteria
Check the zero Setting of the Magnehelic Gauge by disconnecting Tube connections on both ends. Verify the Magnehelic Gauge function when AHU is “ON”
The Magnehelic Gauge should indicate Zero setting. The Magnehelic Gauge should indicate the pressure differential across filter.
Observation &Results
Remarks
Measured DP across Pre 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 SYSTEM NUMBER DOCUMENT NO
Sr. No 1.
2.
Function Parameter Check the zero Setting of the Indicator by keeping the door open of the room which DP to be measured. Verify the DP Indicator function.
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
Acceptance Criteria
PAGE NO. 13 of 21 REV NO: R0
Observation &Results
Remarks
The DP Indicator should indicate Zero setting.
The DP indicator should indicate the pressure differential across Rooms
Measured DP Corridor-4 to Material In:
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 SYSTEM NUMBER DOCUMENT NO
Sr. No. 1.
2.
Function Parameter
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
Acceptance Criteria
PAGE NO. 14 of 21 REV NO: R0
Observation &Results
Remarks
Keep Selector Switch in Manual Mode Function, Keep The AHU in “ON” Condition, Open Blower Motor Access Door when AHU in Running Condition
The motor should stop as soon as the access door lost the contact of limit switch, Green Push Button Indicator should glow in starter panel 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 SYSTEM NUMBER DOCUMENT NO Sl. No
Attributes
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02 Units
1
Total Supply Air Quantity
CFM
2
Fresh Air Quantity
CFM
3
Static Pressure
4
Fan Speed
RPM
5
Motor Speed
RPM
PAGE NO. 15 of 21 REV NO: R0 Design
Actual
Remarks
Mm wg
R 6
Motor Current
Amps
Y B RY
7
Line Voltage
Volts
RB YB
Comments:............................................................................. ........................................................................................... ........................................................................................... .......................................................................................... Tested By :
Inspected By :
Approved By :
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO Name 4.11
2 3
Attributes
Process Air In Dry bulb temperature
6
Process Air In Wet bulb temperature
7
Specific Humidity
8
Process Air Out Qty
Design
Actual
Remarks
CFM
Fresh Air Dry Bulb temperature Fresh Air Wet Bulb temperature
5
11
Units
Pre Cooling Fresh Air Qty
Process Air in Qty
10
Name
DEHUMIDIFIER COMMISSIONING REPORT:
4
9
PAGE NO. 16 of 21 REV NO: R0
Name
Sl. No 1
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
0
F
0
F
CFM 0
F
0
F
No of Grains/
CFM
Process Air out Dry bulb temperature Process Air out Wet bulb temperature Specific Humidity
0
F
0
F
No of Grains/
R 12
Motor Current
Amps
13
Line Voltage
Volts
Y B RY RB YB
Comments:............................................................................. ........................................................................................... ........................................................................................... .......................................................................................... Tested By :
Inspected By :
Approved By :
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
PAGE NO. 17 of 21 REV NO: R0
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
Name Name
Name
5.0 TESTING/MEASURING INSTRUMENTS CALIBRATION STATUS Instrument Name
Inspected By: -
Serial No
Calibration Done on
Calibration Due on
Calibration Report Ref
Approved By: -
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 18 of 21 REV NO: R0
6.0 OBSERVED DEVIATIONS: Details of Deviations
:
Investigation
:
Corrective Action
:
Acceptable
: Yes / No
Deviation Approved By / Date :
Name :
Sign :
Name :
Sign :
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
7.0 RECOMMENDATIONS:
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 19 of 21 REV NO: R0
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 20 of 21 REV NO: R0
8.0 CONCLUSION:
Concluded by: : Date:
(Q.A) Date
(Engineering): Date
: :
:
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 21 of 21 REV NO: R0
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 1 of 21 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 Sr. Manager - Technical
Sr. Executive - QA Corp. Engg.
Signature
Date
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 2 of 21 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 & RESPONSIBILITY
3
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 SYSTEM NUMBER DOCUMENT NO
PAGE NO. 3 of 21 REV NO: R0
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
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. Room Area in Ft2
False Ceiling Height Ft
Room Volume in Ft3
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
Room Name
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.
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 4 of 21 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. 3.0
To review and approval of qualification protocol and report. 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 SYSTEM NUMBER DOCUMENT NO
4.0
HVAC FUNCTIONAL TEST VERIFICATION
4.1
VERIFICATION OF HVAC STARTS UP:
Sr. No.
Function Parameter
PAGE NO. 5 of 21 REV NO: R0
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
Acceptance Criteria
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 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 of the pressure butterfly valves and Outlet of water line.
7.
By pass valve at chilled / The bypass valve should valve functioning. function as and when operated.
functioning Gauges and on the Inlet the chilled
should
Observations & Result
Remarks
start
The butterfly valve should open and close when so operated with the pressure Gauge showing the pressure respective to the position of the valve.
Comments:.................................................................................................................. .......................................................................................................................... Installed By :
Installation Inspected By :
Installation Approved By :
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 6 of 21 REV NO: R0
Name Name 4.2 VERIFICATION OF MOTOR BLOWER ASSEMBLY OPERATION:
Name
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. Activity
Designed acceptance criteria
Check the Supply Blower and Motor assembly for proper fitment on base frame.
Blower and Motor should be properly fitted on base frame and tightened with bolts and nuts.
Check the motor shaft rotation, manually.
Motor shaft should rotate smoothly when rotated manually.
Check the Blower rotation, manually.
Blower should rotate smoothly when rotated manually.
Check the supply air blower for any abnormal sound
There should not be any abnormal sound in the supply air blower.
Check the direction of the rotation of the blower.
Blower should rotate as per the arrow mark indicated on the blower.
Check the Blower RPM by using calibrated Tachometer.
Blower RPM should be 2874 10%
Observations
Remarks
Comments:.................................................................................................................. ................................................................................................................................. ...................................................................................................... Operated By :
Operations Inspected By :
Operations Approved By :
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
Name Name 4.3 VERIFICATION OF PUSH BUTTON OPERATION: Sr. No.
Function Parameter
Acceptance Criteria
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
PAGE NO. 7 of 21 REV NO: R0 Name
Observations & Result
Remarks
Comments:.................................................................................................................. ................................................................................................................................. ......................................................................................................... Tested By :
Inspected By :
Approved By :
Name
Name
Name
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
4.4
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 8 of 21 REV NO: R0
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
1.
AHU-09
Observation
Done By/ Date
Checked By/ Date
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 9 of 21 REV NO: R0
4.5 NEW FILTER INSTALLATION SEQUENCE: Sr. No.
From
OPERATION
Time
1.
Installation of Pre filters and operation of AHU for 24 hrs.
2.
installation of Fine filters and run for 24 Hours
3.
To Date
Time
Date
OBSERVATION
Removal, cleaning and reinstallation of both Pre filters & Fine filters & installation Plenum HEPA Filters. And Run for 24 Hours
Comments:........................................................................................................... ......................................................................................................................... ......................................................................................................................... ......................................................................................................................... ......................................................................................................................... ......................................................................................................................... ......................................................................................................................... .........................................................................................................................
Performed By :
Name:
Inspected By :
Approved By :
Name
Name
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 10 of 21 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
Change and reduce the set point of Temperature and RH Sensor, installed in the Return Air duct, at 18ºC temperature. Note: 1. Set point for controlling chilled water valve actuator is 24ºC 2. Restore the original setting after study.
Three way valve Set the temp. actuator should 24ºC operate the valve to increase the flow of Reduce the chilled water temp. at 18ºC through the coil
Change and increase the set point of Temperature and RH Sensor, installed in the Return Air duct, at 28ºC temperature. Note: 1. Set point for controlling chilled water valve actuator is 22ºC 2. Restore the original setting after study.
Three way valve Set the temp. actuator should 24ºC operate the valve to reduce the flow of Increase the chilled water temp. at 28ºC through the coil
Check for the leakage of chilled water cooling coil visually.
Observations
Remarks
Restore the temp. 24ºC
Restore the temp. 24ºC There should not be any leakage.
Check the leakage
Comments:........................................................................................................... ......................................................................................................................... Operated By :
Inspected By :
Approved By :
Name
Name
Name
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 11 of 21 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
Change and increase the set point of RH Sensor, installed in the Return Air duct, at 55%. Note: 1. Set point Range for controlling Dehumidifier is 40+5% 2. Restore the original setting after study.
The Dehumidifier should switch on when RH in return air RH reaches 45%
Change and decrease the set point of RH Sensor, installed in the Return Air duct, at 25% temperature. Note: 1. Set point for controlling Dehumidifier is 40+5% 2. Restore the original setting after study.
The Dehumidifier should switch off when return air RH reaches 35%
Activity
Observations
Remarks
Set the RH to 40% Increase the RH at 55% Restore the RH at 40% Set the RH to 40% Decrease the RH at 25% Restore the RH at 40%
Comments:........................................................................................................... ......................................................................................................................... ......................................................................................................................... Operated By :
Inspected By :
Approved By :
Name
Name
Name
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 12 of 21 REV NO: R0
4.7 VERIFICATION OF MAGNEHALIC GAUGE OPERATION: MAGNEHELIC GAUGES FOR PRE, FINE & HEPA FILTERS: Sr. No . 1.
2.
Function Parameter
Acceptance Criteria
Check the zero Setting of the Magnehelic Gauge by disconnecting Tube connections on both ends. Verify the Magnehelic Gauge function when AHU is “ON”
The Magnehelic Gauge should indicate Zero setting. The Magnehelic Gauge should indicate the pressure differential across filter.
Observation &Results
Remarks
Measured DP across Pre 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 SYSTEM NUMBER DOCUMENT NO
Sr. No 1.
2.
Function Parameter Check the zero Setting of the Indicator by keeping the door open of the room which DP to be measured. Verify the DP Indicator function.
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
Acceptance Criteria
PAGE NO. 13 of 21 REV NO: R0
Observation &Results
Remarks
The DP Indicator should indicate Zero setting.
The DP indicator should indicate the pressure differential across Rooms
Measured DP Corridor-4 to Material In:
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 SYSTEM NUMBER DOCUMENT NO
Sr. No. 1.
2.
Function Parameter
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
Acceptance Criteria
PAGE NO. 14 of 21 REV NO: R0
Observation &Results
Remarks
Keep Selector Switch in Manual Mode Function, Keep The AHU in “ON” Condition, Open Blower Motor Access Door when AHU in Running Condition
The motor should stop as soon as the access door lost the contact of limit switch, Green Push Button Indicator should glow in starter panel 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 SYSTEM NUMBER DOCUMENT NO Sl. No
Attributes
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02 Units
1
Total Supply Air Quantity
CFM
2
Fresh Air Quantity
CFM
3
Static Pressure
4
Fan Speed
RPM
5
Motor Speed
RPM
PAGE NO. 15 of 21 REV NO: R0 Design
Actual
Remarks
Mm wg
R 6
Motor Current
Amps
Y B RY
7
Line Voltage
Volts
RB YB
Comments:............................................................................. ........................................................................................... ........................................................................................... .......................................................................................... Tested By :
Inspected By :
Approved By :
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO Name 4.11
2 3
Attributes
Process Air In Dry bulb temperature
6
Process Air In Wet bulb temperature
7
Specific Humidity
8
Process Air Out Qty
Design
Actual
Remarks
CFM
Fresh Air Dry Bulb temperature Fresh Air Wet Bulb temperature
5
11
Units
Pre Cooling Fresh Air Qty
Process Air in Qty
10
Name
DEHUMIDIFIER COMMISSIONING REPORT:
4
9
PAGE NO. 16 of 21 REV NO: R0
Name
Sl. No 1
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
0
F
0
F
CFM 0
F
0
F
No of Grains/
CFM
Process Air out Dry bulb temperature Process Air out Wet bulb temperature Specific Humidity
0
F
0
F
No of Grains/
R 12
Motor Current
Amps
13
Line Voltage
Volts
Y B RY RB YB
Comments:............................................................................. ........................................................................................... ........................................................................................... .......................................................................................... Tested By :
Inspected By :
Approved By :
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
PAGE NO. 17 of 21 REV NO: R0
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
Name Name
Name
5.0 TESTING/MEASURING INSTRUMENTS CALIBRATION STATUS Instrument Name
Inspected By: -
Serial No
Calibration Done on
Calibration Due on
Calibration Report Ref
Approved By: -
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 18 of 21 REV NO: R0
6.0 OBSERVED DEVIATIONS: Details of Deviations
:
Investigation
:
Corrective Action
:
Acceptable
: Yes / No
Deviation Approved By / Date :
Name :
Sign :
Name :
Sign :
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
7.0 RECOMMENDATIONS:
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 19 of 21 REV NO: R0
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 20 of 21 REV NO: R0
8.0 CONCLUSION:
Concluded by: : Date:
(Q.A) Date
(Engineering): Date
: :
:
OPERATION QUALIFICATION SYSTEM NAME SYSTEM NUMBER DOCUMENT NO
AIR HANDLING UNIT AHU-09 /NPL/OQ/S-02
PAGE NO. 21 of 21 REV NO: R0
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