Document Control:
Document Number: PQ-PSWM-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Performance Qualification Protocol for Prefilled Syringe Washing Machine
Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Prefilled Syringe Washing Machine used in the production area, ensuring compliance with regulatory standards.
Tags: Equipment Validation, Performance Qualification, Prefilled Syringes, Washing Machine
Objective
The objective of this protocol is to validate the performance of the Prefilled Syringe Washing Machine to ensure it operates within specified parameters and meets the acceptance criteria for washing syringes prior to sterilization.
Scope
This protocol applies to the Prefilled Syringe Washing Machine used in the production area for the washing of prefilled syringes and cartridges. It covers all aspects of performance qualification including critical parameters, acceptance criteria, and evidence collection.
Responsibilities
The following personnel are responsible for the execution of this protocol:
- Validation Specialist: Oversee the validation process and documentation.
- Production Personnel: Operate the washing machine and document results.
- Quality Assurance: Review and approve the final validation report.
Prerequisites
Prior to execution of this protocol, the following must be completed:
- Installation Qualification (IQ) of the Prefilled Syringe Washing Machine.
- Operational Qualification (OQ) of the washing machine.
- Training of personnel on the use of the washing machine.
Equipment Description
The Prefilled Syringe Washing Machine is designed to wash prefilled syringes and cartridges prior to sterilization. It operates using specified wash pressures and temperatures to ensure effective particulate removal, with a PLC audit trail for data integrity.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-001 | Verify wash pressure | Within specified range | Pressure log |
| PQ-002 | Verify wash temperature | Within specified range | Temperature log |
| PQ-003 | Check particulate removal | 99% removal | Particulate test results |
| PQ-004 | Audit trail verification | Complete and accurate | PLC audit trail report |
Detailed Test Cases
Test Case PQ-001:
- Objective: To verify that the wash pressure is within the specified range.
- Procedure: Measure the wash pressure during operation.
- Acceptance Criteria: Pressure must be within the defined limits.
- Evidence: Document the pressure readings in the log.
Test Case PQ-002:
- Objective: To verify that the wash temperature is within the specified range.
- Procedure: Measure the wash temperature during operation.
- Acceptance Criteria: Temperature must be within the defined limits.
- Evidence: Document the temperature readings in the log.
Test Case PQ-003:
- Objective: To check the effectiveness of particulate removal.
- Procedure: Conduct a particulate test on washed syringes.
- Acceptance Criteria: 99% removal of particulates.
- Evidence: Document test results and observations.
Test Case PQ-004:
- Objective: To verify the accuracy of the PLC audit trail.
- Procedure: Review the PLC audit trail for completeness.
- Acceptance Criteria: All entries must be complete and accurate.
- Evidence: Document findings in the audit trail report.
Deviations
Any deviations from the protocol must be documented and justified. Approval from Quality Assurance is required for any changes to the protocol or acceptance criteria.
Approvals
This document must be approved by the following individuals:
- Validation Specialist: ____________________ Date: ___________
- Quality Assurance: ______________________ Date: ___________
- Production Manager: ____________________ Date: ___________