PERFORMANCE QUALIFICATION PROTOCOL
TABLE OF CONTENTS
1.0 PROTOCOL APPROVAL
10.0 REVISION OF PROTOCOL
1.0 PROTOCOL APPROVAL:
Protocol Prepared by:
QA is responsible for the preparation of protocol for Performance Qualification of Nitrogen plant.
Protocol Checked by:
Validation Core Committee Member responsible to review the Protocol for performance qualification of Nitrogen plant located in Utility section.
Protocol Approved by:
DGM – Tech is responsible to approve the performance qualification protocol.
The objective of this protocol is to establish sufficient data to assure that the Nitrogen plant is suitable for the production of nitrogen gas qualifies for the performance qualification used in various processes of production department. Validation of the Nitrogen gas is carried out by monitoring the Microbial Quality of Nitrogen gas from all the User Points.
Performance Qualification Protocol shall provide the Methodology of qualification studies, Criteria of Qualification procedure and a guideline for documentation of the study.
- These procedures are to be performed after the installation and operational qualification have been completed and approved.
- These procedures are to be performed, as per the schedule given to assure that the system performance is consistent between the period, after completion of performance qualification study and before conducting a revalidation study.
- These procedures are to be performed after any major modification of the equipment or relocation and for revalidation during appropriate intervals.
- Any change in user point location and pipe line.
- To show that the Nitrogen Plant installed in the Utility section performs for its intended use.
- A plan to carry out the validation shall be prepared in the form of a protocol.
- The validation team members shall be responsible to carry out the validation.
Head – Quality Assurance.
- VALIDATION TEAM MEMBERS :
- SYSTEM DESCRIPTION
Pure nitrogen is obtained by removing oxygen from air in two stages. Oil free compressed air is first dehumidified (anhydrous alumina is the desiccant) and is passed through a 0.01 micron filter and then column of Carbon Molecular Sieve (CMS) where oxygen is adsorbed from this column. Then it is further purified by passing through a copper catalyst column where nitrogen of purity of 99.99 % is obtained. This plant also has an oxygen analyzer which is connected to an automatic dumping system which operates when the oxygen content is more than 2 ppm.
The Nitrogen is further filtered through 0.01 micron and is circulated to different user points through SS 316 L pipelines. Terminal additional 0.22 micron filter is given at all user points. All the user point lines are made out of PU.
Validation of nitrogen gas system includes
- Moisture content
- Oil content.
- Non viable particles count
- Viable particles count
- Dew Point
- TEST PROGRAM AND ACCEPTANCE CRITERIA
- MICROBIAL QUALITY
Monitor quality of Nitrogen gas from all the user points for three consecutive days. Microbial content by bubbling Nitrogen gas from 0.22 micron final filter through 200 ml of filtered highly purified water. Then that water is handover to microbiology department for sterility testing.
At the end of 14 days incubation, the media shall show no growth of organisms in the Broth for all the three runs.
- PARTICLE COUNT TESTING:
Monitor the quality of Nitrogen gas from all the user points for three consecutive days, particulate content by bubbling the Nitrogen gas from 0.22 micron filter in 0.22 micron filtered WFI for 5 minutes. Testing the bubbled water for particulate matter by liquid particle counter.
For all the user points: 10 micron size should not more than 6000 particles,20 micron size should not more than 600 particles.
- MOITURE AND OIL CONTENT:
Check the chemical quality (presence of Moiture and Oil content) of the Nitrogen gas from plant out let and other user points by blowing the Nitrogen gas on to a Blotting paper.
Nitrogen gas from Plant Out let and other user points shall not have moisture and oil present in it.
- REVALIDATION CRITERIA
System should be revalidated under following conditions
- Major changes have been done to the system
- Every year
- After completion of each study, a report shall be prepared by the validation team members which shall include the following information.
- Tabulated Data.
- Validation Team Members and their Signatures.
- Summary Report
- Evolution of results
- Quality Assurance Department Certification.
- WFI → Water For Injection
- NMT → Not More Than.
- NLT → Not Less Than.
- GTP → General Test Procedure
10.0 REVISION OF PROTOCOL:
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