Design Qualification Protocol for Bag Washing / Blow-off Station

Objective

The objective of this Design Qualification (DQ) protocol is to ensure that the Bag Washing / Blow-off Station is designed and operates according to predefined specifications, ensuring the removal of particulates from IV infusion bags.

Scope

This protocol applies to the Bag Washing / Blow-off Station utilized in the production area for the washing of IV infusion bags (LVP/SVP) to ensure product quality and compliance with regulatory requirements.

Responsibilities

• Validation Team: Responsible for the execution and documentation of the DQ protocol.
• Quality Assurance: Responsible for the review and approval of the DQ protocol and results.
• Production Personnel: Responsible for the operation of the equipment in accordance with established procedures.

Prerequisites

• Completion of User Requirement Specification (URS) for the equipment.
• Installation Qualification (IQ) must be completed prior to DQ execution.
• Training of personnel on equipment operation and safety procedures.

Equipment Description

The Bag Washing / Blow-off Station is designed to remove particulates from IV infusion bags. It utilizes air pressure for the blow-off process and is equipped with a filter integrity monitoring system. The PLC logs critical parameters to ensure compliance with operational standards.

Test Plan

Detailed Test Cases

Test Case T1: Verify Air Pressure Filter Integrity

Objective: To ensure the air pressure filter integrity is functioning correctly.

Procedure: Measure the air pressure at the filter and compare against the specifications outlined in the URS.

Acceptance Criteria: Air pressure must be within the specified range as per URS Annex 11.

Evidence: Record of measurements and PLC logs.

Test Case T2: Review PLC Logs for Operational Parameters

Objective: To confirm that all PLC monitored parameters are within acceptable limits during operation.

Procedure: Retrieve and review PLC logs for the past production cycle.

Acceptance Criteria: All parameters must be within established limits as defined in the URS.

Evidence: PLC log review report.

Deviations

Any deviations observed during the execution of this protocol must be documented and assessed for impact on product quality and compliance. A corrective action plan must be developed and implemented for any critical deviations.

Approvals

This protocol must be reviewed and approved by the Quality Assurance team prior to execution. All results must be signed off by the Validation Team and Quality Assurance upon completion of the DQ protocol.