Document Control
Document Number: PQ-ET-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Sanitary Transfer Pump in IV Infusions
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Sanitary Transfer Pump operates in accordance with the specified requirements and is capable of transferring bulk solutions without compromising product quality.
Scope
This protocol applies to the Sanitary Transfer Pump used in the production area for the transfer of low-volume parenteral (LVP) and small-volume parenteral (SVP) solutions in bags and bottles.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Team: Responsible for providing necessary access and support during the PQ execution.
Prerequisites
- Sanitary Transfer Pump installed and operational.
- All relevant personnel trained on equipment operation.
- Availability of required materials and solutions for testing.
Equipment Description
The Sanitary Transfer Pump is a Mag Drive/Centrifugal pump designed for the safe and efficient transfer of bulk solutions in a sterile environment. It features a shear seal integrity mechanism to prevent contamination and ensure product quality during transfer.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| TP-001 | Verify flow rate at specified settings. | Flow rate within defined limits. | Flow rate measurement logs. |
| TP-002 | Check shear seal integrity. | No leaks detected. | Leak test results. |
Detailed Test Cases
Test Case 1: Verify Flow Rate
Test ID: TP-001
Procedure: Measure the flow rate of the pump at various settings (low, medium, high) using a calibrated flow meter.
Acceptance Criteria: Flow rate must be within the limits specified in the User Requirement Specification (URS).
Evidence: Document flow rate measurements in the validation log.
Test Case 2: Check Shear Seal Integrity
Test ID: TP-002
Procedure: Conduct a leak test by running the pump with water and monitoring for any signs of leakage around the shear seal.
Acceptance Criteria: No leaks should be detected during the test.
Evidence: Document results in the validation log.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be developed to address any identified issues.
Approvals
Prepared by: [Name]
Date: [Insert Date]
Reviewed by: [Name]
Date: [Insert Date]
Approved by: [Name]
Date: [Insert Date]