Design Qualification Protocol for Sterile Holding Tank in Production
Document Control:
Document Number: DQ-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 Sterile Holding Tank (Pressurized) is designed and installed in compliance with the specified requirements and is suitable for its intended use in holding sterile filtered bulk.
Scope
This protocol applies to the Design Qualification of the Sterile Holding Tank utilized in the production area for sterile powders and lyophilized products. It covers the evaluation of the equipment’s design, installation, and operational capabilities.
Responsibilities
The following personnel are responsible for the execution of this protocol:
- Validation Team: Overall oversight and execution of the DQ protocol.
- Engineering Team: Equipment installation and technical support.
- Quality Assurance: Review and approval of the DQ protocol and results.
Prerequisites
Prior to executing this DQ protocol, the following must be completed:
- Completion of User Requirement Specification (URS).
- Installation of the Sterile Holding Tank as per manufacturer specifications.
- Training of personnel on equipment operation and maintenance.
Equipment Description
The Sterile Holding Tank (Pressurized) is designed for holding sterile filtered bulk under controlled pressure conditions. It is critical for maintaining the integrity and sterility of the product prior to further processing.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify pressure hold integrity. | Pressure remains stable within specified limits. | PLC logs, pressure readings. |
| DQ-02 | Check vent integrity. | No leaks detected during testing. | Leak test results. |
Detailed Test Cases
Test Case DQ-01: Verify Pressure Hold Integrity
Procedure: Monitor the pressure of the Sterile Holding Tank over a 24-hour period. Record pressure readings at 1-hour intervals.
Acceptance Criteria: Pressure must remain stable within ± 5 psi of the set point.
Evidence: PLC logs and recorded pressure readings will be attached to the final report.
Test Case DQ-02: Check Vent Integrity
Procedure: Perform a leak test on the vent system using a calibrated leak detector.
Acceptance Criteria: No leaks should be detected during the test.
Evidence: Leak test results will be documented and included in the final report.
Deviations
Any deviations from the acceptance criteria must be documented and approved by the Quality Assurance department prior to proceeding with further validation activities.
Approvals
This Design Qualification Protocol requires sign-off by the following individuals:
- Validation Manager: ______________________ Date: ___________
- Quality Assurance: ______________________ Date: ___________
- Engineering Lead: ______________________ Date: ___________