Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Sterile Hold Tank in IV Infusions
Objective: To establish the requirements and testing necessary to qualify the Sterile Hold Tank used in the production of IV infusions.
Scope: This protocol applies to the Design Qualification of the Sterile Hold Tank located in the Production area for holding sterile bulk before filling.
Responsibilities:
- Validation Team: Prepare and execute the protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Ensure the equipment is operated according to the protocol.
Prerequisites:
- Installation Qualification (IQ) completed.
- Operational Qualification (OQ) completed.
- Personnel trained on equipment operation and validation procedures.
Equipment Description:
The Sterile Hold Tank is a pressurized vessel designed to hold sterile bulk solutions prior to filling into IV infusion bags or bottles. The equipment is critical for maintaining the sterility and quality of the product.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify pressure hold | Pressure maintained within specified range | Pressure log |
| DQ-001-02 | Vent filter integrity test | No breaches detected | Filter integrity report |
| DQ-001-03 | Temperature monitoring | Temperature within specified limits | Temperature log |
Detailed Test Cases:
Test Case 1: Pressure Hold Verification
- Procedure: Monitor and log pressure for 1 hour.
- Acceptance Criteria: Pressure should remain stable within +/- 5% of the set point.
- Evidence: Pressure log to be attached.
Test Case 2: Vent Filter Integrity Test
- Procedure: Conduct a bubble point test on the vent filter.
- Acceptance Criteria: No bubbles should appear indicating integrity.
- Evidence: Filter integrity report to be attached.
Test Case 3: Temperature Verification
- Procedure: Record temperature at 15-minute intervals for 1 hour.
- Acceptance Criteria: Temperature should remain within the specified range of 20-25°C.
- Evidence: Temperature log to be attached.
Deviations:
Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team.
Approvals:
Prepared By: ___________________ Date: ___________
Approved By: ___________________ Date: ___________