Document Number: PQ-001
Revision: 1.0
Date: 2023-10-01
Prepared By: [Your Name]
Approved By: [Approver Name]
Performance Qualification Protocol for Bag Washing / Blow-off Station
Meta Description: This document outlines the Performance Qualification protocol for the Bag Washing / Blow-off Station used in the production of IV Infusions, ensuring compliance with URS Annex11.
Tags: Equipment Validation, Performance Qualification, IV Infusions, Bag Washing, Blow-off Station
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Bag Washing / Blow-off Station’s capability to effectively remove particulates from IV infusion bags, ensuring product integrity and compliance with regulatory standards.
Scope
This protocol applies to the Bag Washing / Blow-off Station utilized in the production area for IV infusions (LVP/SVP – Bags/Bottles). It covers the qualification of the equipment, including critical parameters and acceptance criteria.
Responsibilities
The following roles are responsible for the execution and approval of this protocol:
- Validation Team: Execute the PQ protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Manager: Ensure equipment availability and compliance during testing.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary equipment and materials.
- Training of personnel on equipment operation and safety protocols.
Equipment Description
The Bag Washing / Blow-off Station is designed to remove particulates from IV infusion bags. The station utilizes air pressure for cleaning and is equipped with a PLC for monitoring and control of critical parameters.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-001-01 | Verify air pressure filter integrity | Pass if pressure is within specified range | Pressure logs |
| PQ-001-02 | Review PLC logs for operational consistency | All logs must show normal operation | PLC log reports |
Detailed Test Cases
Test Case 1: Air Pressure Filter Integrity
Objective: To ensure the air pressure filter is functioning correctly.
Procedure: Measure the air pressure at the filter outlet using calibrated equipment. Record the readings.
Acceptance Criteria: Air pressure must be within the specified operational range.
Evidence: Documented pressure logs will be stored in the validation folder.
Test Case 2: PLC Log Review
Objective: To confirm the PLC logs indicate normal operation throughout the qualification process.
Procedure: Retrieve and review PLC logs for any anomalies during the testing period.
Acceptance Criteria: No errors or warnings should be present in the logs.
Evidence: PLC log reports will be maintained for audit purposes.
Deviations
Any deviations from the protocol must be documented and assessed for impact on the qualification results. A deviation report must be submitted for approval by the Quality Assurance team.
Approvals
This protocol must be reviewed and approved by the following individuals:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance Manager: ______________________ Date: __________
- Production Manager: ______________________ Date: __________