Inline Sterile Filtration Skid – OQ Protocol

Document Number: OQ-ISF-001

Version: 1.0

Effective Date: [Insert Date]

Reviewed By: [Insert Name]

Approval Date: [Insert Date]

Operational Qualification Protocol for Inline Sterile Filtration Skid

Objective: To validate the Inline Sterile Filtration Skid to ensure it meets specified requirements for sterilizing filtration prior to filling.

Scope: This protocol applies to the Inline Sterile Filtration Skid used in the production area for sterile powders and lyophilized products.

Responsibilities:

  • Validation Team: Responsible for executing the OQ protocol and documenting results.
  • Quality Assurance: Responsible for reviewing and approving the protocol and results.
  • Production Team: Responsible for providing access to the equipment and necessary operational support.

Prerequisites:

  • Completion of Installation Qualification (IQ).
  • Training of personnel on equipment operation.
  • Availability of all necessary documentation and logs.

Equipment Description:

The Inline Sterile Filtration Skid is designed for sterilizing filtration of products prior to filling, ensuring the removal of microorganisms and particulates. It operates under critical parameters that directly impact product quality.

Test ID Procedure Acceptance Criteria Evidence
OQ-001 Verify Flow Rate Flow rate within specified range Flow rate log
OQ-002 Perform DP Integrity Test DP integrity test passes Integrity test report
OQ-003 Review Audit Trail Logs No discrepancies in logs Audit trail log review

Detailed Test Cases:

  • Test Case OQ-001: Measure the flow rate during operation and ensure it remains within the specified range. Document the results in the flow rate log.
  • Test Case OQ-002: Conduct a Differential Pressure (DP) integrity test according to the SOP. Document the results in the integrity test report.
  • Test Case OQ-003: Review the audit trail logs for any discrepancies. Ensure all entries are accurate and complete.
See also  Sampling Booth (Downflow/RLAF) – PQ Protocol

Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented.

Approvals:

__________________________
Validation Team Lead

__________________________
Quality Assurance Manager

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