Document Number: DQ-OSD-SBV-001
Version: 1.0
Effective Date: YYYY-MM-DD
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Design Qualification Protocol for Split Butterfly Valve Transfer System
Objective
The objective of this Design Qualification Protocol is to ensure that the Split Butterfly Valve Transfer System operates as intended and meets the specified requirements for contained docking and transfer in Solid Dosage Form production.
Scope
This protocol applies to the Split Butterfly Valve Transfer System utilized in the Production/Containment area for direct product impact, classified as critical equipment.
Responsibilities
The following personnel are responsible for executing this protocol:
- Validation Team: Execute the testing and document results.
- Quality Assurance: Review and approve the protocol and results.
- Engineering: Provide technical support and equipment specifications.
Prerequisites
- Completion of installation and operational qualification (IQ/OQ).
- Availability of necessary documentation (URS, design specifications).
- Personnel trained in validation procedures.
Equipment Description
The Split Butterfly Valve Transfer System is designed for contained docking and transfer of materials in Solid Dosage Form production. It ensures a secure containment seal during operation, minimizing the risk of product exposure.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Verify containment seal integrity during docking. | Seal integrity confirmed with no leaks. | Leak test report. |
| DQ-002 | Test operational functionality of the SBV system. | System operates without errors. | Operational log. |
Detailed Test Cases
Test Case DQ-001: Containment Seal Integrity
Procedure: Initiate docking process and monitor for leaks using appropriate detection methods.
Acceptance Criteria: No leaks detected during the test.
Evidence: Documented results from the leak test.
Test Case DQ-002: Operational Functionality
Procedure: Execute a series of operational tests to ensure the system functions as intended.
Acceptance Criteria: All operations performed without error.
Evidence: Operational logs and any error reports.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on the validation process. A corrective action plan should be established as necessary.
Approvals
Prepared By: ______________________ Date: ___________
Approved By: ______________________ Date: ___________