Document Control
Document Number: IQ-AHU-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for AHU in Aseptic Area
Meta Description: This document outlines the Installation Qualification (IQ) protocol for the Air Handling Unit (AHU) serving the aseptic area, ensuring compliance with critical parameters for sterile injectables.
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Air Handling Unit (AHU) for the aseptic area is installed correctly and operates within specified limits to ensure compliance with regulatory requirements for sterile injectables.
Scope
This protocol applies to the Air Handling Unit (AHU) utilized in the aseptic area of the Engineering department, specifically for HVAC serving classified rooms impacting product quality.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and addressing deviations. Engineering will oversee installation and maintenance of the AHU.
Prerequisites
All installation activities must be completed, and necessary documentation (e.g., URS, design specifications) must be available for review prior to executing this protocol.
Equipment Description
The AHU is designed to provide controlled airflow, temperature, and humidity for classified aseptic areas, ensuring compliance with critical parameters such as ACH, airflow, temperature, relative humidity, differential pressure, alarms, trends, and audit trails.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-001 | Verify installation of AHU components | All components installed as per specifications | Installation checklist |
| IQ-002 | Check ACH airflow | ACH within specified limits | Flow measurement data |
| IQ-003 | Measure temperature and RH | Temperature and RH within specified limits | Calibration certificates |
| IQ-004 | Verify differential pressure | DP within specified limits | Pressure measurement data |
| IQ-005 | Test alarm functionality | All alarms functional and documented | Alarm test report |
| IQ-006 | Review trends and audit trails | All records complete and accurate | Audit trail review documentation |
Detailed Test Cases
Test ID IQ-001: Verify installation of AHU components.
Procedure: Inspect all components against installation checklist.
Acceptance Criteria: All components must match specifications.
Evidence: Complete installation checklist with signatures.
Test ID IQ-002: Check ACH airflow.
Procedure: Measure airflow using an anemometer.
Acceptance Criteria: ACH must be within specified limits.
Evidence: Flow measurement data report.
Test ID IQ-003: Measure temperature and RH.
Procedure: Use calibrated sensors to measure temperature and RH.
Acceptance Criteria: Both parameters must be within specified limits.
Evidence: Calibration certificates and measurement logs.
Test ID IQ-004: Verify differential pressure.
Procedure: Measure DP across HEPA filters.
Acceptance Criteria: DP must fall within specified limits.
Evidence: Pressure measurement data report.
Test ID IQ-005: Test alarm functionality.
Procedure: Trigger alarms and verify response.
Acceptance Criteria: All alarms must activate as expected.
Evidence: Alarm test report with timestamps.
Test ID IQ-006: Review trends and audit trails.
Procedure: Examine historical data and audit trails for completeness.
Acceptance Criteria: All records must be accurate and up-to-date.
Evidence: Audit trail review documentation.
Deviations
Any deviations from the acceptance criteria must be documented, investigated, and resolved prior to final approval of the IQ protocol.
Approvals
Prepared By: [Insert Name]
Approved By: [Insert Name]
Date: [Insert Date]