Document Control
Document Number: IQ-SBV-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Split Butterfly Valve Transfer System
Objective
The objective of this Installation Qualification (IQ) Protocol is to verify that the Split Butterfly Valve (SBV) Transfer System is installed correctly and operates as intended in the production/containment area.
Scope
This protocol applies to the Split Butterfly Valve Transfer System utilized for contained docking and transfer in the production area, impacting product quality directly.
Responsibilities
- Validation Team: Responsible for execution and documentation of the IQ protocol.
- Quality Assurance: Responsible for review and approval of the protocol.
- Maintenance Team: Responsible for ensuring the equipment is operational prior to IQ execution.
Prerequisites
- Completion of equipment installation.
- Availability of necessary tools and materials for testing.
- Training of personnel involved in the IQ process.
Equipment Description
The Split Butterfly Valve Transfer System is designed for contained docking and transfer of solid dosage forms. It provides critical containment seal integrity during operation, ensuring a safe transfer process.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation of SBV Transfer System components. | All components installed as per manufacturer specifications. | Installation checklist. |
| IQ-02 | Check containment seal integrity during docking. | Seal integrity maintained without leaks. | Leak test results. |
Detailed Test Cases
Test Case 1: Verify Installation of SBV Transfer System Components
Procedure: Inspect each component of the SBV Transfer System to ensure proper installation as per the manufacturer’s specifications. Document any discrepancies.
Acceptance Criteria: All components must be installed correctly, with no missing parts.
Evidence: Completed installation checklist signed by the validation team.
Test Case 2: Check Containment Seal Integrity During Docking
Procedure: Perform a leak test to verify the integrity of the containment seal during docking operations. Document the results.
Acceptance Criteria: The containment seal must maintain integrity without any detectable leaks during the test.
Evidence: Leak test results documented and signed by the validation team.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A deviation report should be completed, outlining the nature of the deviation, potential impact, and corrective actions taken.
Approvals
Protocol prepared by: ______________________
Date: ______________________
Reviewed by: ______________________
Date: ______________________
Approved by: ______________________
Date: ______________________