Design Qualification Protocol for Isolator/RABS System in Aseptic Processing
Document Control:
Document Number: DQ-ISOLATOR-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Isolator/RABS System provides a suitable aseptic processing environment for the production of prefilled syringes and cartridges, meeting all specified requirements and regulatory standards.
Scope
This protocol applies to the validation of the Isolator/RABS System used in the production area for aseptic processing of prefilled syringes and cartridges. It covers the critical parameters, acceptance criteria, and testing procedures necessary for validation.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for ensuring equipment is installed and functioning as intended.
Prerequisites
- Completion of Installation Qualification (IQ).
- Availability of relevant documentation including User Requirements Specification (URS) and operational procedures.
Equipment Description
The Isolator/RABS System is designed to provide an aseptic processing environment for the filling of prefilled syringes and cartridges. The system features pressure integrity monitoring and a validated VHP cycle for sterilization.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Pressure Integrity Test | Maintain pressure integrity throughout the cycle | Test logs, Visual inspection report |
| DQ-02 | VHP Cycle Audit Trail Review | Complete and accurate audit trail logs | Audit trail log report |
Detailed Test Cases
Test Case DQ-01: Pressure Integrity Test
Objective: To verify that the Isolator/RABS System maintains pressure integrity.
Procedure: Perform a pressure integrity test as per the validated procedure. Record the pressure data over the cycle duration.
Acceptance Criteria: The system must maintain pressure integrity without any leaks.
Evidence: Documented test logs and visual inspection report.
Test Case DQ-02: VHP Cycle Audit Trail Review
Objective: To ensure the VHP cycle audit trail is complete and accurate.
Procedure: Review the audit trail logs generated during the VHP cycle for completeness and accuracy.
Acceptance Criteria: All logs must be complete and without discrepancies.
Evidence: Audit trail log report.
Deviations
Any deviations from the established procedures must be documented and reviewed. A corrective action plan should be developed and implemented for any critical deviations.
Approvals
Prepared By: [Insert Name] – [Insert Date]
Reviewed By: [Insert Name] – [Insert Date]
Approved By: [Insert Name] – [Insert Date]