Document ID: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Design Qualification Protocol for Port/Outlet Welding Station in IV Infusions Production
Objective: To establish and document the design qualification of the Port/Outlet Welding Station utilized in the production of IV Infusions (LVP/SVP – Bags/Bottles).
Scope: This protocol applies to the Port/Outlet Welding Station located in the Production area, focusing on the critical parameters affecting the welding process of IV infusion bags.
Responsibilities:
- Validation Team: Responsible for executing the protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for operating the equipment according to validated procedures.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of relevant Standard Operating Procedures (SOPs).
- Training of personnel on the operation of the Port/Outlet Welding Station.
Equipment Description: The Port/Outlet Welding Station is designed to weld ports onto IV infusion bags. It is equipped with temperature, time, and pressure controls, along with integrity alarms and logging capabilities to ensure compliance with production standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify weld temperature settings | Temperature within specified range as per URS Annex11 | Calibration log |
| T2 | Check weld time accuracy | Time within specified limits as per URS Annex11 | Time log |
| T3 | Assess pressure integrity | Pressure does not exceed limits as per URS Annex11 | Pressure test results |
| T4 | Review integrity alarms functionality | All alarms activate correctly | Alarm log |
Detailed Test Cases:
- Test Case 1: Verify that the weld temperature is set to 180°C. Record the temperature using the equipment’s logging system.
- Test Case 2: Confirm that weld time is set to 5 seconds. Document the time using the equipment’s logging system.
- Test Case 3: Conduct a pressure test to confirm that the welding pressure does not exceed 10 psi. Record the results.
- Test Case 4: Simulate a failure to ensure alarms activate. Document alarm activation and response times.
Data Integrity Checks:
- Ensure all temperature, time, and pressure logs are timestamped and stored securely.
- Verify that all alarm logs are reviewed and discrepancies are documented.
- Conduct periodic audits of the logging system to ensure data accuracy.
Deviations: Any deviations from the acceptance criteria must be documented, investigated, and resolved prior to approval of the qualification.
Approvals:
- Prepared by: ________________________ Date: ___________
- Reviewed by: ________________________ Date: ___________
- Approved by: ________________________ Date: ___________