Document Control
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Vial Washing Machine
Meta Description: This document outlines the Performance Qualification protocol for a Vial Washing Machine used in the production of sterile powders and lyophilized products.
Tags: Performance Qualification, Equipment Validation, Vial Washing Machine
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Vial Washing Machine operates within specified parameters to ensure effective cleaning of vials prior to sterilization.
Scope
This protocol applies to the Vial Washing Machine used in the Production area for the washing of vials intended for sterile powders and lyophilized products.
Responsibilities
The Validation Team is responsible for executing this protocol and documenting results. The Quality Assurance (QA) team will review and approve the final report.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary cleaning agents and materials.
- Access to relevant Standard Operating Procedures (SOPs).
Equipment Description
The Vial Washing Machine is designed to wash vials using high-pressure water jets to remove particulates and contaminants before sterilization. The machine is equipped with programmable logic control (PLC) for monitoring and logging operational parameters.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-001 | Verify wash pressure | Pressure within specified range | PLC logs |
| TP-002 | Verify wash temperature | Temperature within specified range | PLC logs |
| TP-003 | Verify particulate removal | No visible particulates post-wash | Visual inspection records |
Detailed Test Cases
Test Case 1: Wash Pressure Verification
Objective: To ensure that the wash pressure is within the specified range.
Procedure: Monitor the wash pressure during operation using the PLC.
Acceptance Criteria: Pressure must be within the defined range as per URS Annex11.
Expected Result: Recorded pressures fall within the acceptable range.
Test Case 2: Wash Temperature Verification
Objective: To ensure that the wash temperature is maintained within the specified range.
Procedure: Monitor the wash temperature during operation using the PLC.
Acceptance Criteria: Temperature must be within the defined range as per URS Annex11.
Expected Result: Recorded temperatures fall within the acceptable range.
Test Case 3: Particulate Removal Verification
Objective: To confirm that the washing process effectively removes visible particulates.
Procedure: Conduct a visual inspection of vials post-wash.
Acceptance Criteria: No visible particulates should be present.
Expected Result: All inspected vials show no visible particulates.
Deviations
Any deviations from the acceptance criteria will be documented and investigated. A corrective action plan will be developed as necessary.
Approvals
This protocol must be approved by the following personnel:
- Validation Team Lead: _______________________ Date: ___________
- Quality Assurance Manager: _______________________ Date: ___________