Document Control Number: PQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approved By: [Name]
Performance Qualification Protocol for RABS/Isolator in Ophthalmics Production
Meta Description: This document outlines the Performance Qualification (PQ) Protocol for RABS/Isolator used in the production of sterile ophthalmic products, ensuring compliance with regulatory standards.
Tags: Performance Qualification, Equipment Validation, Ophthalmics, RABS, Isolator, Aseptic Barrier
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the RABS/Isolator system operates within the defined parameters to ensure the integrity and sterility of the ophthalmic products produced.
Scope
This protocol applies to the RABS/Isolator system utilized in the production area for filling sterile eye drops and eye ointments. It covers all aspects of the equipment validation process.
Responsibilities
The Quality Assurance (QA) team is responsible for the approval and oversight of the PQ protocol. The Validation team will execute the protocol and document results. Production personnel will assist in the execution of tests as required.
Prerequisites
- Completed Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and materials for testing.
- Training of personnel involved in the PQ execution.
Equipment Description
The RABS/Isolator system serves as an aseptic barrier for the filling of sterile ophthalmic products. It includes glove ports for operator access and is equipped with a VHP (Vaporized Hydrogen Peroxide) decontamination cycle.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Leak Integrity Test | No leaks detected | Test report |
| TP-002 | Glove Integrity Test | Gloves pass integrity test | Test report |
| TP-003 | VHP Cycle Log Review | All cycles within specified parameters | Log report |
Detailed Test Cases
Test Case ID: TP-001
Procedure: Perform a leak test on the RABS/Isolator system to ensure no air leaks are present.
Acceptance Criteria: No leaks detected.
Evidence: Documented test report with results.
Test Case ID: TP-002
Procedure: Conduct a glove integrity test using a suitable method (e.g., pressure decay).
Acceptance Criteria: Gloves must pass the integrity test without any breaches.
Evidence: Documented test report with results.
Test Case ID: TP-003
Procedure: Review VHP cycle logs to confirm all cycles were executed according to predefined parameters.
Acceptance Criteria: All cycles must be within specified parameters.
Evidence: Log reports reviewed and signed off by QA.
Deviations
Any deviations from the acceptance criteria must be documented, investigated, and resolved prior to final approval of the PQ results.
Approvals
This protocol must be reviewed and approved by the QA team before execution. Final results must also be approved by the QA manager.