Document Control Number: IQ-001
Version: 1.0
Effective Date: 2023-10-01
Prepared by: [Prepared By]
Reviewed by: [Reviewed By]
Approved by: [Approved By]
Installation Qualification Protocol for Solution Preparation Tank in IV Infusions
This document outlines the Installation Qualification (IQ) protocol for the Solution Preparation Tank used for dissolving solids into solution in the production of IV infusions.
Objective: To ensure that the Solution Preparation Tank is installed correctly and operates as intended to meet the requirements specified in the User Requirement Specification (URS) Annex 11.
Scope: This protocol applies to the Installation Qualification of the Solution Preparation Tank used in the production area for IV infusions (LVP/SVP – Bags/Bottles).
Responsibilities:
- Validation Team: Oversee the execution of the IQ protocol.
- Maintenance Team: Ensure equipment is properly installed and maintained.
- Quality Assurance: Review and approve IQ documentation.
Prerequisites:
- Completion of equipment installation.
- Availability of relevant documentation (URS, equipment manuals).
- Training of personnel on equipment operation.
Equipment Description:
The Solution Preparation Tank is designed for the dissolution of solids such as salt and sugar into a solution. It is critical for ensuring the quality and consistency of the IV infusion products.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation according to manufacturer’s specifications. | Installation matches specifications. | Installation checklist signed off. |
| IQ-02 | Check all connections (water, electrical, etc.) for integrity. | No leaks or faults present. | Inspection report. |
| IQ-03 | Conduct initial temperature and conductivity checks. | Temperature within specified range; conductivity as per specifications. | Calibration logs. |
| IQ-04 | Verify PLC logs for proper functionality. | All logs recorded accurately. | PLC log review report. |
| IQ-05 | Test agitation time for specified duration. | Agitation time meets requirements. | Agitation log. |
Detailed Test Cases:
- Test ID: IQ-01 – Confirm that the equipment is installed as per the installation manual. Document any discrepancies.
- Test ID: IQ-02 – Inspect all connections and document any leaks or faults found during inspection.
- Test ID: IQ-03 – Measure temperature and conductivity using calibrated equipment. Document results.
- Test ID: IQ-04 – Review PLC logs for accuracy and completeness. Report any anomalies.
- Test ID: IQ-05 – Monitor agitation time and document adherence to specified duration.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the validation team and Quality Assurance.
Approvals: This protocol must be approved by the Validation Manager and Quality Assurance prior to execution.
Data Integrity Checks:
- Ensure PLC logs are automatically recorded and backed up daily.
- Temperature and conductivity measurements should be logged electronically with timestamps.
- Agitation time should be monitored through automated timers with alerts for deviations.