Document ID: DQ-ETP-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver Name]
Design Qualification Protocol for Sanitary Transfer Pump in IV Infusions
Objective
To establish a Design Qualification (DQ) protocol for the Sanitary Transfer Pump to ensure that it meets the required specifications and standards for transferring bulk solutions in IV infusions.
Scope
This protocol applies to the validation of the Sanitary Transfer Pump used in the production area for IV infusions (LVP/SVP – Bags/Bottles). It covers the equipment’s installation, operational, and performance qualifications.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for providing operational input and ensuring compliance during the validation process.
Prerequisites
- Completion of User Requirement Specification (URS).
- Availability of Sanitary Transfer Pump.
- Training of personnel on equipment operation.
Equipment Description
The Sanitary Transfer Pump (Mag Drive/Centrifugal) is designed to transfer bulk solutions with a focus on maintaining flow shear seal integrity. It is critical for ensuring the quality and safety of IV infusions.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-TP-001 | Verify installation and setup of the pump. | Installation meets URS specifications. | Installation checklist. |
| DQ-TP-002 | Conduct flow shear seal integrity testing. | Flow shear seal integrity maintained. | Test results report. |
Detailed Test Cases
Test Case 1: Installation Verification
Objective: To confirm that the Sanitary Transfer Pump is installed correctly.
Procedure: Inspect the installation of the pump against the installation checklist.
Acceptance Criteria: All items on the checklist must be completed.
Evidence: Signed installation checklist.
Test Case 2: Flow Shear Seal Integrity
Objective: To ensure the flow shear seal integrity is maintained during operation.
Procedure: Run the pump at specified flow rates and monitor for leaks.
Acceptance Criteria: No leaks detected during testing.
Evidence: Flow shear seal integrity test report.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be established to address any issues found during testing.
Approvals
All results and documentation must be reviewed and approved by the Quality Assurance department to ensure compliance with regulatory standards.