Document Control:
Document Number: PQ-ISOLATOR-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Performance Qualification Protocol for Isolator/RABS System in Aseptic Processing
Objective: To validate the performance of the Isolator/RABS System to ensure it provides a reliable aseptic processing environment for the production of prefilled syringes and cartridges.
Scope: This protocol applies to the Isolator/RABS System used in the aseptic processing area for the production of prefilled syringes and cartridges. It covers the qualification of the equipment to meet the requirements defined in the User Requirement Specification (URS) and relevant regulatory guidelines.
Responsibilities:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Ensure equipment is maintained and operated according to SOPs.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary documentation and equipment.
- Training of personnel on equipment operation and validation procedures.
Equipment Description: The Isolator/RABS System provides a controlled environment for aseptic processing, ensuring sterility during the filling of prefilled syringes and cartridges. Key features include HEPA filtration, pressure integrity monitoring, and VHP (Vaporized Hydrogen Peroxide) decontamination capabilities.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Pressure Integrity Test | System maintains pressure within specified limits | Test log and calibration certificate |
| PQ-002 | VHP Cycle Audit Trail Review | Audit trail logs show successful VHP cycles | Audit trail report |
Detailed Test Cases:
- Test Case PQ-001: Conduct a pressure integrity test of the Isolator/RABS system. Ensure the system maintains the required pressure throughout the test duration. Document results and any deviations.
- Test Case PQ-002: Review the VHP cycle audit trail logs for compliance. Confirm that all cycles are recorded and meet the specified criteria. Document any discrepancies found during the review.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A deviation report should be generated and reviewed by the validation team and quality assurance.
Approvals:
- Validation Team Lead: ___________________ Date: ___________
- Quality Assurance Manager: ______________ Date: ___________
CSV Data Integrity Checks:
- Ensure that all electronic records are backed up and maintain integrity throughout the PQ process.
- Verify that audit trails are enabled and functioning correctly for all critical parameters.
- Confirm that user access controls are in place to prevent unauthorized modifications.