Document Control:
Protocol Number: PQ-VF-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Performance Qualification Protocol for Vent Filter in IV Infusion Production
Meta Description: This document outlines the Performance Qualification protocol for the Vent Filter used in IV Infusions, ensuring compliance with URS Annex1 standards.
Tags: Performance Qualification, Equipment Validation, IV Infusions, Vent Filter, Production
Objective
The objective of this Performance Qualification (PQ) protocol is to verify the integrity and functionality of the Vent Filter (Sterile Gas Filter Assembly) used in the production of IV Infusions, ensuring that it maintains sterility in the tank vent.
Scope
This protocol applies to the Vent Filter utilized in the production area for IV Infusions (LVP/SVP – Bags/Bottles) and is intended for use by the validation team and production personnel.
Responsibilities
The following roles are responsible for the execution and oversight of this protocol:
- Validation Team: Overall execution and documentation of the PQ.
- Production Personnel: Operation of the Vent Filter and provision of necessary data.
- Quality Assurance: Review and approval of the protocol and results.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ) for the Vent Filter.
- Training of personnel on the use of the Vent Filter.
- Availability of necessary equipment and materials for testing.
Equipment Description
The Vent Filter (Sterile Gas Filter Assembly) is designed to maintain sterility in the tank vent during the production of IV Infusions. It is critical for preventing contamination and ensuring product integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-VF-001 | Integrity Test – Pressure Hold | Must hold pressure as per URS Annex1 | Test results documentation |
Detailed Test Cases
Test Case 1: Integrity Test – Pressure Hold
- Objective: To ensure the Vent Filter maintains integrity under specified pressure.
- Procedure: Apply pressure as specified in the URS Annex1 and monitor for leaks over a defined period.
- Acceptance Criteria: No pressure drop observed during the test duration.
- Expected Results: Pressure should remain stable, indicating integrity of the filter.
Deviations
Any deviations from the specified procedures or acceptance criteria must be documented, along with the rationale for the deviation and any impact assessment on product quality.
Approvals
This protocol must be reviewed and approved by the following individuals:
- Validation Manager: ______________________
- Quality Assurance: ______________________
- Production Supervisor: ______________________