Document Number: IQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Installation Qualification Protocol for Bag Washing / Blow-off Station
Meta Description: This document outlines the Installation Qualification (IQ) protocol for the Bag Washing / Blow-off Station used in IV Infusions, ensuring compliance with URS Annex11.
Tags: Equipment Validation, Installation Qualification, IV Infusions, Bag Washing, Blow-off Station
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Bag Washing / Blow-off Station is installed according to manufacturer specifications and is capable of performing its intended function in the production area.
Scope
This protocol applies to the Bag Washing / Blow-off Station used in the production of IV Infusions (LVP/SVP – Bags/Bottles) within the production area. It covers all aspects of the installation and functional verification of the equipment.
Responsibilities
The following personnel are responsible for the execution of this protocol:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Engineering Team: Responsible for the installation of the equipment.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
Prerequisites
- Completion of the equipment installation.
- Availability of necessary documentation (URS, design specifications, etc.).
- Training of personnel on equipment operation.
Equipment Description
The Bag Washing / Blow-off Station is designed to remove particulates from IV infusion bags. It operates using a combination of air pressure and filtration systems to ensure the integrity of the bags prior to filling.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-001 | Verify installation against manufacturer specifications. | All components installed as per specifications. | Installation checklist signed off. |
| IQ-002 | Check air pressure filter integrity. | Filter integrity test results within acceptable range. | Test log with results. |
| IQ-003 | Review PLC logs for operational history. | PLC logs show no errors during initial operation. | PLC log report. |
Detailed Test Cases
Test Case: IQ-001
Objective: Verify installation against manufacturer specifications.
Procedure: Inspect each component of the Bag Washing / Blow-off Station to ensure it matches the manufacturer’s installation guidelines.
Acceptance Criteria: All components must be installed as per specifications.
Evidence: Installation checklist signed off by the validation team.
Test Case: IQ-002
Objective: Check air pressure filter integrity.
Procedure: Conduct a filter integrity test following standard operating procedures.
Acceptance Criteria: Filter integrity test results must be within the acceptable range as defined by the manufacturer.
Evidence: Documented test log with results.
Test Case: IQ-003
Objective: Review PLC logs for operational history.
Procedure: Access and review PLC logs from the initial operation of the Bag Washing / Blow-off Station.
Acceptance Criteria: PLC logs should show no errors during initial operation.
Evidence: PLC log report documenting operational history.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on equipment performance and product quality. A deviation report should be prepared for any discrepancies found during testing.
Approvals
This protocol must be reviewed and approved by the Quality Assurance team before implementation.