Document Control:
Document ID: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Sterile Hold Tank Used in IV Infusions
Objective: To validate the performance of the Sterile Hold Tank (Pressurized) used for holding sterile bulk before filling to ensure compliance with quality and regulatory standards.
Scope: This protocol applies to the Sterile Hold Tank utilized in the production area for IV infusions (LVP/SVP – Bags/Bottles). It encompasses the validation of critical parameters impacting product quality.
Responsibilities:
- Validation Team: Overall execution and documentation of the PQ protocol.
- Quality Assurance: Review and approval of the protocol and results.
- Production Personnel: Support in conducting tests and providing necessary data.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and materials.
- Training of personnel involved in the PQ process.
Equipment Description:
The Sterile Hold Tank (Pressurized) is designed to hold sterile bulk solutions prior to filling. It maintains a controlled environment to ensure product integrity and safety. Key critical parameters include pressure, hold, vent filter integrity, and temperature.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001-01 | Verify pressure hold for 24 hours. | Pressure remains within specified limits. | Pressure log records. |
| PQ-001-02 | Test vent filter integrity. | No leakage detected. | Filter integrity test report. |
| PQ-001-03 | Monitor temperature for 24 hours. | Temperature remains within specified limits. | Temperature log records. |
Detailed Test Cases:
- Test Case ID: PQ-001-01
- Test Case ID: PQ-001-02
- Test Case ID: PQ-001-03
Procedure: Monitor and log the pressure in the Sterile Hold Tank over a 24-hour period.
Acceptance Criteria: Pressure must remain within the specified limits as defined in the URS.
Evidence: Documented pressure logs for the 24-hour period.
Procedure: Conduct a vent filter integrity test using a validated method.
Acceptance Criteria: No leakage should be detected during testing.
Evidence: Integrity test report showing results.
Procedure: Monitor and log the temperature of the Sterile Hold Tank for 24 hours.
Acceptance Criteria: Temperature must remain within the specified limits as defined in the URS.
Evidence: Documented temperature logs for the 24-hour period.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.
Approvals:
- Prepared by: ________________________
- Approved by: ________________________
- Date: ________________________