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

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: __________