Sterile Hold Tank (Pressurized) – OQ Protocol

Document Control Number: OQ-001

Version: 1.0

Effective Date: [Insert Date]

Reviewed By: [Insert Name]

Approval Date: [Insert Date]

Operational Qualification Protocol for Sterile Hold Tank in IV Infusions

Objective: To validate the operational performance of the Sterile Hold Tank used for holding sterile bulk before filling in the production area.

Scope: This protocol applies to the Sterile Hold Tank utilized for IV infusions (LVP/SVP – Bags/Bottles) within the production area, ensuring compliance with URS Annex 1 and Annex 15 standards.

Responsibilities:

  • Validation Team: Execute and document the OQ protocol.
  • Quality Assurance: Review and approve the OQ protocol and results.
  • Production Team: Ensure equipment is prepared and maintained during the qualification process.

Prerequisites:

  • Installation Qualification (IQ) must be completed and approved.
  • All personnel involved must be trained in the operation of the Sterile Hold Tank.

Equipment Description:

The Sterile Hold Tank is a pressurized container designed to hold sterile bulk solutions prior to filling. It is equipped with a pressure hold vent filter to ensure sterility and prevent contamination.

Test ID Procedure Acceptance Evidence
OQ-001-01 Verify pressure hold integrity. Pressure holds for a minimum of 30 minutes without drop. Pressure log records.
OQ-001-02 Test vent filter integrity. No contamination detected in post-test samples. Microbial test results.
OQ-001-03 Measure temperature during hold. Temperature remains within specified range. Temperature log records.

Detailed Test Cases:

  1. Test Case OQ-001-01:
    • Procedure: Set the Sterile Hold Tank to the desired pressure and monitor for 30 minutes.
    • Acceptance Criteria: No pressure drop observed.
    • Evidence: Documented pressure readings at intervals.
  2. Test Case OQ-001-02:
    • Procedure: Conduct a microbial test after the vent filter has been in use.
    • Acceptance Criteria: No microbial growth.
    • Evidence: Microbial test report.
  3. Test Case OQ-001-03:
    • Procedure: Monitor the temperature of the Sterile Hold Tank during the hold period.
    • Acceptance Criteria: Temperature remains within specified limits.
    • Evidence: Temperature log records.
See also  Checkweigher – Deviation Impact Assessment

Deviations: Any deviations from the acceptance criteria must be documented, including the reason for the deviation and corrective actions taken.

Approvals: The final report must be reviewed and approved by the Quality Assurance team, along with signatures from all responsible personnel.

Data Integrity Checks:

  • Ensure all pressure readings are logged in real-time.
  • Verify that temperature logs are timestamped and signed off by operators.
  • Conduct regular audits of microbial test results for compliance.

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