Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 1 of 28

Performance Qualification (PQ)

Palltronic® Flowstar FFS04(B,S,R) Integrity Test Device

Software Version : .....................................

Instrument Serial Number : .....................................

Pre-approvals

Department Name Signature Date

Final-approvals

Department Name Signature Date

Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 2 of 28

Signature Record

Each person to be involved in documenting, verifying or approving any part of the

execution of this protocol must record the specified information in the table below in
order to positively identify all signatures and initials recorded in the execution of this
protocol.

Printed Name Signature Initials Date

Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 3 of 28

Contents

Pre-approvals ......................................................................................................... 1
Final-approvals...................................................................................................... 1
Test No : 1.1 ............................................................................................................ 4
Check on Forward Flow test function of the Palltronic Flowstar device under user
conditions. ................................................................................................................. 4
Test No : 1.2............................................................................................................. 7
Check on Forward Flow test function of the Palltronic Flowstar device under user
conditions and using a process filter. ......................................................................... 7
Test 1.3 ..................................................................................................................... 9
Check on Forward Flow test function of the Palltronic Flowstar device under user
conditions and using a process filter. ......................................................................... 9
Test No : 2.1 .......................................................................................................... 11
Check on Water Intrusion test function of the Palltronic Flowstar device under user
conditions. ............................................................................................................... 11
Test No : 2.2 .......................................................................................................... 14
Check on water intrusion test function of the Palltronic Flowstar device under user
conditions and using a process filter. ....................................................................... 14
Test No : 2.3 .......................................................................................................... 16
Check on water intrusion test function of the Palltronic Flowstar device under user
conditions and using a process filter. ....................................................................... 16
Test No : 3.1 .......................................................................................................... 18
Check on Bubble Point test function of the Palltronic Flowstar device. .................... 18
Test No : 3.2 .......................................................................................................... 21
Check on bubble point test function of the Palltronic Flowstar device under user
conditions and using a process filter. ....................................................................... 21
Test No : 3.3 .......................................................................................................... 23
Check on bubble point test function of the Palltronic Flowstar device under user
conditions and using a process filter. ....................................................................... 23
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 4 of 28

Test No : 1.1

Check on Forward Flow test function of the Palltronic Flowstar device under user
conditions.

Purpose of Test :

To verify that Forward Flow values reported by the Palltronic Flowstar device
when operated under user conditions are accurate and reproducible.

Test Method :

Perform a Forward Flow integrity test using the Palltronic Flowstar device on a
reference capillary (e.g. Palltronic Flow Check FC02 unit). Perform the test
according to the procedure described in the Operating Instructions. Use a 300 second
test time. Compare the final results reported by the Palltronic Flowstar device with
the reference flow values for the capillary at this test pressure.

Retain the print outs from the test performed.

Acceptance Criteria :

The test has passed if the Palltronic Flowstar Forward Flow measurement is within ±
10% of the flow values for the reference capillary at the same test pressure.

Continued ...
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 5 of 28

Test No 1.1 continued …

Measured flow Flow of the Within

(ml/min) reference capillary Tolerance ?
(Yes / No)

Reference Flow Device Type:

(See Appendix 1)
Serial No:

Calibration Due:

Acceptance Criteria Achieved

( Yes / No)?

Comments :

Completed By : Date :

Approved By : Date :
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 6 of 28

Test No 1.1
Test Result Printout:
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 7 of 28

Test No : 1.2

Check on Forward Flow test function of the Palltronic Flowstar device under user
conditions and using a process filter.

Purpose of Test :

To prove that the operator is able to prepare the filter assembly, connect it properly to the
Palltronic Flowstar device and perform a Forward Flow test under process conditions.

Test Method :
Prepare process filter in accordance with Standard Operating Procedure Number……… for
unused filters.
Perform a Forward Flow integrity test using the Palltronic Flowstar device on a new,
unused, process filter in the production area. Perform the test according to the procedure
described in the Operating Instructions. (or Standard Operating Procedure Number………)

Retain the print out from the test performed.

Acceptance Criteria :

This performance qualification has passed if the forward flow test completes without error.

Acceptance Criteria Achieved

( Yes / No)?

Comments :

Completed By : Date :

Approved By : Date :
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 8 of 28

Test No 1.2
Test Result Printout:
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 9 of 28

Test 1.3

Check on Forward Flow test function of the Palltronic Flowstar device under user
conditions and using a process filter.

Purpose of Test :

To prove that the operator is able to prepare the filter assembly, connect it properly to
the Palltronic Flowstar device and perform a Forward Flow test under process
conditions.

Test Method :
Prepare process filter in accordance with Standard Operating Procedure
Number……… for used filters.
Perform a Forward Flow integrity test using the Palltronic Flowstar device on a used
process filter in the production area. Perform the test according to the procedure
described in the Operating Instructions. (or Standard Operating Procedure
Number………)

Retain the print out from the test performed.

Acceptance Criteria :

This performance qualification has passed if the forward flow test completes without
error.

Acceptance Criteria Achieved

( Yes / No)?

Comments :

Completed By : Date :

Approved By : Date :
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 10 of 28

Test No 1.3
Test Result Printout:
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 11 of 28

Test No : 2.1

Check on Water Intrusion test function of the Palltronic Flowstar device under user
conditions.

Purpose of Test :

To verify that Water Intrusion values reported by the Palltronic Flowstar device are accurate
and reproducible when operated under user conditions.

Test Method :

Perform a Water Intrusion integrity test using the Palltronic Flowstar device on a reference
capillary (e.g. Palltronic Flow Check FC01 unit). Perform the test according to the
procedure described in the Operating Instructions. Use a 300 second test time. Compare the
final results reported by the Palltronic Flowstar device with the reference flow value for the
capillary at this test pressure.

Retain the print outs from the test performed.

Acceptance Criteria :

The test has passed if the Palltronic Flowstar Water Intrusion measurements are within ±
10% of the flow values for the reference capillary at the same test pressure.

Note: To convert the known flow rate of the Palltronic Flow Check device from air flow rate
to water flow rate, divide the air flow rate by the test pressure in bar absolute. For tests
performed in psi, the conversion factor is air flow rate x 14,5 / test pressure (absolute) in psi.

Continued ...
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 12 of 28

Test No 2.1 continued …

Measured flow Flow of the Within

(ml/min) reference capillary Tolerance ?
(calculated as (Yes / No)
water flow rate)

Reference Flow Device Type:

(See Appendix 1)
Serial No:

Calibration Due:

Acceptance Criteria Achieved

( Yes / No)?

Comments :

Completed By : Date :

Approved By : Date :
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 13 of 28

Test No 2.1
Test Result Printout:
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 14 of 28

Test No : 2.2

Check on water intrusion test function of the Palltronic Flowstar device under user
conditions and using a process filter.

Purpose of Test :

To prove that the operator is able to prepare the filter assembly, connect it properly to the
Palltronic Flowstar device and perform a water intrusion test under process conditions.

Test Method :

Prepare a process filter in accordance with Standard Operating Procedure Number……. For
unused filters.

Perform a water intrusion integrity test using the Palltronic Flowstar device on a new,
unused, process filter in the production area. Perform the test according to the procedure
described in the Operating Instructions (or Standard Operation Procedure Number……….).

Retain the print out from the test performed.

Acceptance Criteria :

This performance qualification has passed if the water intrusion test completes without error.

Acceptance Criteria Achieved

( Yes / No)?

Comments :

Completed By : Date :

Approved By : Date :
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 15 of 28

Test No 2.2
Test Result Printout:
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 16 of 28

Test No : 2.3

Check on water intrusion test function of the Palltronic Flowstar device under user
conditions and using a process filter.

Purpose of Test :

To prove that the operator is able to prepare the filter assembly, connect it properly to the
Palltronic Flowstar device and perform a water intrusion test under process conditions.

Test Method :

Prepare a process filter in accordance with Standard Operating Procedure Number……. for
used filters.

Perform a water intrusion integrity test using the Palltronic Flowstar device on a used
process filter in the production area. Perform the test according to the procedure described in
the Operating Instructions (or Standard Operation Procedure Number……….).

Retain the print out from the test performed.

Acceptance Criteria :

This performance qualification has passed if the water intrusion test completes without error.

Acceptance Criteria Achieved

( Yes / No)?

Comments :

Completed By : Date :

Approved By : Date :
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 17 of 28

Test No 2.2
Test Result Printout:
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 18 of 28

Test No : 3.1

Check on Bubble Point test function of the Palltronic Flowstar device.

Purpose of Test :

To verify that the Palltronic Flowstar device correctly detects a bubble point under user
conditions. A pre-set spring relief valve is needed for this test. The relief valve setpoint
should be checked against an accurate calibrated pressure reference device before
commencing the test.

Test Method :

Perform a bubble point test using the Palltronic Flowstar unit on a pre-set spring relief
valve under user conditions. Perform the test according to the procedure described in the
Operating Instructions.

Retain the printed output.

Acceptance Criteria :

The test has passed if the bubble point results reported by the Palltronic Flowstar device are
within ± 10% of the known setpoint of the spring relief valve.

Continued ...
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 19 of 28

Test No 3.2 continued …

Please circle applicable units of pressure

Flowstar Spring Relief Valve Within

Bubble Point Setpoint Tolerance ?
(mbarg / psig) (mbarg / psig) (Yes / No)

Reference Pressure Device Type :

(See Appendix 1)
Serial No :

Calibration Due:

Acceptance Criteria Achieved

( Yes / No)?

Comments :

Completed By : Date :

Approved By : Date :
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 20 of 28

Test No 3.1
Test Result Printout:
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 21 of 28

Test No : 3.2

Check on bubble point test function of the Palltronic Flowstar device under user conditions
and using a process filter.

Purpose of Test :

To prove that the operator is able to prepare the filter assembly, connect it properly to the
Palltronic Flowstar device and perform a bubble point test under process conditions.

Test Method :

Prepare process filter in accordance with Standard Operating Procedure Number……… for
new filters.

Perform a Bubble Point integrity test using the Palltronic Flowstar device on a new, unused
process filter in the production area. Perform the test according to the procedure described
in the Operating Instructions. (or Standard Operating Procedure Number………)

Retain the print out from the test performed.

Acceptance Criteria :

This performance qualification has passed if the bubble point test passes without error.

Acceptance Criteria Achieved

( Yes / No)?

Comments :

Completed By : Date :

Approved By : Date :
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 22 of 28

Test No 3.2
Test Result Printout:
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 23 of 28

Test No : 3.3

Check on bubble point test function of the Palltronic Flowstar device under user conditions
and using a process filter.

Purpose of Test :

To prove that the operator is able to prepare the filter assembly, connect it properly to the
Palltronic Flowstar device and perform a bubble point test under process conditions.

Test Method :

Prepare a process filter in accordance with Standard Operating Procedure Number……… for
used filters.

Perform a Bubble Point integrity test using the Palltronic Flowstar device on a used process
filter in the production area. Perform the test according to the procedure described in the
Operating Instructions. (or Standard Operating Procedure Number………)

Retain the print out from the test performed.

Acceptance Criteria :

This performance qualification has passed if the bubble point test passes without error.

Acceptance Criteria Achieved

( Yes / No)?

Comments :

Completed By : Date :

Approved By : Date :
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 24 of 28

Test No 3.3
Test Result Printout:
 Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 25 of 28

APPENDIX A - DEVIATION, IMPACT AND CORRECTIVE ACTION SHEET

Device: Palltronic Flowstar FFS04S Integrity Test Device

Project No:
Deviation No: Document Ref.: PQ Sample Protocols
Page No: Item No:
Deviation Description:

Impact of Deviation:

Tester: Signature: Date:

Corrective Action:

Approval: Signature: Date:

Corrective Action Carried Out And Complete:

Approval: Signature: Date:

Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 26 of 28

APPENDIX B – CALIBRATION CERTIFICATES

CALIBRATION CERTIFICATION FOR

REFERENCE MEASUREMENT

EQUIPMENT
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 27 of 28

APPENDIX C -DOCUMENT AMMENDMENTS

VERSION DATE ITEM CHANGE PAGE
Sample PQ Test Protocol for the Palltronic Flowstar Instrument Page 28 of 28

APPENDIX D – REFERENCE DOCUMENTS

TITLE DOCUMENT NUMBER ISSUE

Palltronic Flowstar Operating Instructions