Sterile Hold Tank (Pressurized) – PQ Protocol

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.
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Detailed Test Cases:

  • Test Case ID: PQ-001-01

    • 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.

  • Test Case ID: PQ-001-02

    • 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.

  • Test Case ID: PQ-001-03

    • 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: ________________________

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