Performance Qualification
Protocol Number: PQ_VO_3.2 Rev. No: 3.2 Tag No.: QC-AI-011
Customer
: FCR Organics
Equipment : VACUUM OVEN
Model No. : NLVO1SE
Serial No. : NLVO-1024-0023
Tag No. : QC-AI-011
System Location : Hot Zone Room
Protocol Pre Approval
Company
Name : .....................................................
Prepared By:
Sign : .....................................................
Newtronic Life Care Equipment Pvt.Ltd.
Company
Name : .....................................................
Reviewed By
Sign : .....................................................
FCR Organics.
Company
Name : .....................................................
Approved By
Sign : .....................................................
FCR Organics.
Test Execution Details
Name : .....................................................
Company
Test Executed By Sign : .....................................................
Newtronic Life Care Equipment Pvt.Ltd.
Date : .....................................................
Name : .....................................................
Company
Test Verified By Sign : .....................................................
FCR Organics.
Date : .....................................................
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Performance Qualification
Protocol Number: PQ_VO_3.2 Rev. No: 3.2 Tag No.: QC-AI-011
Contents:
1 Protocol approval............................................................................................................. 3
2 Brief Description...............................................................................................................3
3 Purpose............................................................................................................................. 3
4 Test procedures................................................................................................................3
4.1 Test rules.....................................................................................................................3
5 Responsibilities relatives to the protocol, execution of tests and report...................4
6 Material and equipement to use......................................................................................4
7 To check the Calibration of temperature in chamber....................................................5
7.1 Acceptance Criteria....................................................................................................5
7.2 List of Documents to Include In the Qualification Dossier.....................................5
7.3 External Sensor position...........................................................................................6
7.4 Internal & External sensor placement diagram.......................................................7
8 Deviation Protocol............................................................................................................ 8
9 Appendix........................................................................................................................... 9
10 Approval of test results..................................................................................................10
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Performance Qualification
Protocol Number: PQ_VO_3.2 Rev. No: 3.2 Tag No.: QC-AI-011
1 PROTOCOL APPROVAL
The responsible person signing the Pre-Approval page (page no: 1) had reviewed and approved the
Performance Qualification protocol for Newtronic make Vacuum Oven. Signing of this protocol indicates
that the contents of the documents had been reviewed, all test procedures are accurate and the
acceptance criteria are applicable for the intended purpose of this study.
2 BRIEF DESCRIPTION
The qualification study will be performed to check the Control system supporting the Vacuum Oven that
is supplied to …………………………………………………..at………………………………….for study.
The direction of the sequence of operation must be controlled by a control system and successful
completion of these qualification requirements will provide assurance that the Vacuum Oven Operates
and function as required in the processing environment and meets operational requirements.
3 PURPOSE
The purpose of this document is to verify the performance of the Vacuum Ovens, installed within
company; it consists in the following consecutive sub-activities:
4 TEST PROCEDURES
The Performance for Vacuum Oven shall be verified by performing mappingin loaded condition, using
the test data sheets provided in the protocol. The test data sheets will be used to document the
performance of the Vacuum Oven and to verify that the temperature condition conforms to the User
Requirements.
4.1 Test rules
The PQ forms are intended for entering tests notations pertaining to individual tests and any deviations
that may occur.All Loaded test result must be completed manually during the test execution, as well as
for the remarks areas.
If the test is not applicable please marked "N / A” (not applicable) or "N / R" (nothing to report). All
corrections must be dated and done by hand. The original info has to be crossed out by a single line.
The corrected information must be clearly visible.
Each completed tests has to be signed and dated. Deviations from the PQ specification that occur must
be registered in the deviation protocol and recorded in the appendix.
The PQ is concluding if all acceptance criteria are fulfilled and the notation / deviations registered in the
deviation protocol are remedied or accepted.
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Performance Qualification
Protocol Number: PQ_VO_3.2 Rev. No: 3.2 Tag No.: QC-AI-011
5 RESPONSIBILITIES RELATIVES TO THE PROTOCOL, EXECUTION
OF TESTS AND REPORT
Newtronic Lifecare Equipment is responsible for the creation of this protocol.
………………………………………………………………………………… representatives are responsible to
approve this Protocol within the Stability Chambers
……………………………………………………………………. documents.
Newtronic is responsible to execute the tests in requested order.
6 MATERIAL AND EQUIPEMENT TO USE
Newtronic calibrated measure recorder equipment for temperature includes:
Sensors (aquisition system of temperature).
Electronic interface base module linked to sensors ( Instrument identification and instrument calibration verification).
A local printer
Full instrumentation identification and qualification report of used program.
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Performance Qualification
Protocol Number: PQ_VO_3.2 Rev. No: 3.2 Tag No.: QC-AI-011
7 TO CHECK THE CALIBRATION OF TEMPERATURE IN CHAMBER
a) Set the Login Interval of the machine controller at an interval of 10 minutes so as to record the
temperature.
b) Program the Calibrator unit in order to record the temperature with a 10 minutes frequency interval.
c) Keep Calibrator sensors to the Chamber
d) Allow the chamber to get stabilize as per the set conditions.
e) Extract and print the raw data from the machine controller and the Calibrator unit
f) Determine the time where the temperatures of the inbuilt and the external 1 sensors are stabilized
g) Run the Chamber 1 Hours for Calibration
h) Put in tabular format all recorded data.
7.1 Acceptance Criteria
Temperature distribution in the chamber:
Temperature (°C)
………… ± 2°C
7.2 List of Documents to Include In the Qualification Dossier
- Measured raw data of temperature
- Calibration certificate(s) of the sensors used for the qualification.
Everything ok Yes / No Signature Date
Executor
Verified by
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Performance Qualification
Protocol Number: PQ_VO_3.2 Rev. No: 3.2 Tag No.: QC-AI-011
7.3 External Sensor position
01 calibrator sensors are used for mapping of the chamber.
External Sensor Connection to
unit ok
Sensor position Inside the Chamber
No Sensors ID
(Yes / No)
1.
Comments …………………………………………………………………………………………………
(Ref.)
…………………………………………………………………………………………………
Attachments …………………………………………………………………………………………………
(Ref.)
…………………………………………………………………………………………………
Everything ok Yes / No Signature Date
Executor
Verified by
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Performance Qualification
Protocol Number: PQ_VO_3.2 Rev. No: 3.2 Tag No.: QC-AI-011
7.4 Internal & External sensor placement diagram
Chamber sensor
1 1
Calibrator sensor
It is recommended to photograph and Calibrator sensor
Comments
…………………………………………………………………………………………………
(Ref.)
…………………………………………………………………………………………………
Attachments
…………………………………………………………………………………………………
(Ref.)
…………………………………………………………………………………………………
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Performance Qualification
Protocol Number: PQ_VO_3.2 Rev. No: 3.2 Tag No.: QC-AI-011
8 DEVIATION PROTOCOL
Sequential no:………………………………………..
Deviations to the acceptance criteria that occur during testing need to be stated in the deviation
protocol. One deviation protocol must be created for each deviation and the sequential number to be
indicated accordingly.
The deviation protocol can be copied as required.
Description of ……………………………………………………………………………………
problem
……………………………………………………………………………………
……………………………………………………………………………………
……………………………………………………………………………………
……………………………………………………………………………………
……………………………………………………………………………………
Measures for
trouble shooting
……………………………………………………………………………………
……………………………………………………………………………………
……………………………………………………………………………………
……………………………………………………………………………………
……………………………………………………………………………………
……………………………………………………………………………………
Remarks
……………………………………………………………………………………
……………………………………………………………………………………
……………………………………………………………………………………
Executor Sign: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Date:. . . . . . . . . . . . . . . . . .
Verified/
accepted by Sign: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date:. . . . . . . . . . . . . . . . . .
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Performance Qualification
Protocol Number: PQ_VO_3.2 Rev. No: 3.2 Tag No.: QC-AI-011
9 APPENDIX
Annexure Number Contents Number of
pages
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Performance Qualification
Protocol Number: PQ_VO_3.2 Rev. No: 3.2 Tag No.: QC-AI-011
10 APPROVAL OF TEST RESULTS
The PQ is approved if all acceptance criteria are fulfilled and the notations / deficiencies registered in
the deviation protocol are remedied or fully accepted.
Approved by:
Tests executed Name Signature and Date
Executor: .......................... ........................
All Test criteria have been
Name Signature and Date
fulfilled
Verified: .......................... ........................
All Test criteria have been
Name Signature and Date
fulfilled
Approved: .......................... ........................
Remarks
..........................................................
..........................................................
..........................................................
..........................................................
..........................................................
..........................................................
..........................................................
..........................................................
..........................................................
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