Document Control
Document Number: PQ-SanitaryTransferPump-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approval Date: YYYY-MM-DD
Performance Qualification Protocol for Sanitary Transfer Pump
Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Sanitary Transfer Pump used in the production of nasal and otic products, focusing on flow rate and shear seal integrity.
Tags: Equipment Validation, Performance Qualification, Sanitary Transfer Pump, Nasal Products, Otic Products
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Sanitary Transfer Pump operates consistently and reliably within predetermined specifications for transferring sterile and non-sterile solutions.
Scope
This protocol applies to the Sanitary Transfer Pump used in the production area for the transfer of nasal and otic products, both sterile and non-sterile.
Responsibilities
The Validation Team is responsible for conducting the PQ, documenting results, and ensuring compliance with the acceptance criteria. The Quality Assurance (QA) team will review and approve the protocol and results.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the use of the Sanitary Transfer Pump.
- Availability of all necessary materials and equipment for testing.
Equipment Description
The Sanitary Transfer Pump is designed to transfer sterile and non-sterile solutions in a controlled manner. It features a flow rate adjustment mechanism and a shear seal to ensure product integrity during transfer.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Measure flow rate at various settings. | Flow rate must be within ±10% of specified rate. | Flow rate measurement logs. |
| PQ-02 | Perform shear seal integrity test. | No leaks detected under pressure. | Leak test results. |
Detailed Test Cases
Test Case PQ-01: Flow Rate Measurement
Objective: To ensure the pump delivers the specified flow rate.
Procedure: Adjust the pump to the specified flow rate settings and record the output flow rate using a calibrated flow meter.
Acceptance Criteria: The flow rate must be within ±10% of the specified rate.
Documentation: Record all measurements in the validation log.
Test Case PQ-02: Shear Seal Integrity Test
Objective: To verify the integrity of the shear seal during operation.
Procedure: Pressurize the system to operational levels and inspect for any leaks.
Acceptance Criteria: No leaks detected under pressure.
Documentation: Record results in the validation log.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan must be developed to address any non-conformances.
Approvals
Prepared By: ____________________ Date: ___________
Reviewed By: ____________________ Date: ___________
Approved By: ____________________ Date: ___________