Operational Qualification Protocol for the Split Butterfly Valve Transfer System
Document Number: OQ-SBV-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Split Butterfly Valve (SBV) Transfer System operates in accordance with the User Requirement Specification (URS) and meets the defined acceptance criteria for containment seal integrity during docking and transfer operations.
Scope
This protocol applies to the Split Butterfly Valve Transfer System used in the production and containment areas for solid dosage forms (OSD). It encompasses the qualification of the system to ensure direct product impact and criticality are adequately addressed.
Responsibilities
The following personnel are responsible for executing this protocol:
- Validation Team: Conducts the qualification tests and documents results.
- Quality Assurance: Reviews and approves the protocol and results.
- Operations: Provides operational support during testing.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- All necessary training for personnel must be completed.
- Equipment must be cleaned and ready for use.
Equipment Description
The Split Butterfly Valve Transfer System is designed for contained docking and transfer of materials in solid dosage form production. It ensures the integrity of the containment seal during operation, preventing contamination and ensuring product quality.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-SBV-001 | Verify containment seal integrity during docking. | Containment seal integrity must be maintained with no leaks. | Leak test results, visual inspection records. |
| OQ-SBV-002 | Check operational functionality of the SBV system. | System must operate without errors or alarms. | Operational logs, system performance data. |
Detailed Test Cases
Test Case 1: Containment Seal Integrity
Procedure: Dock the SBV system and perform a leak test using a suitable method (e.g., pressure decay).
Acceptance Criteria: No leaks detected during the test period.
Evidence: Documented results of the leak test.
Test Case 2: Operational Functionality
Procedure: Operate the SBV system through a complete cycle of docking and transfer.
Acceptance Criteria: System operates without any errors or alarms; all parameters within specified range.
Evidence: Operational logs and performance data recorded during the test.
Deviations
Any deviations from the protocol must be documented and justified. Approval for deviations must be obtained from Quality Assurance before proceeding with testing.
Approvals
Prepared by: ______________________ Date: ___________
Approved by: ______________________ Date: ___________