Document Number: PQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approval Date: YYYY-MM-DD
Performance Qualification Protocol for AHU in Aseptic Area
Meta Description: This document outlines the Performance Qualification protocol for the Air Handling Unit (AHU) serving the Aseptic Area, ensuring compliance with industry standards.
Tags: Equipment Validation, Performance Qualification, Aseptic Area, HVAC
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Air Handling Unit (AHU) serving the Aseptic Area operates within defined specifications and meets the acceptance criteria outlined in the User Requirement Specification (URS) and relevant regulatory guidelines.
Scope
This protocol applies to the performance qualification of the AHU utilized in the sterile manufacturing process for injectables. It encompasses testing of critical parameters to ensure compliance with regulatory standards.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Engineering: Responsible for maintaining the AHU and providing necessary documentation.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary documentation including URS, SOPs, and maintenance logs.
- Calibration of measurement instruments used in testing.
Equipment Description
The Air Handling Unit (AHU) is a utility system designed to provide filtered and conditioned air to classified rooms in the aseptic manufacturing area. It ensures that the critical parameters of airflow, temperature, relative humidity (RH), differential pressure (DP), alarms, trends, and audit trails are maintained within specified limits.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| TP-01 | Measure ACH | ≥ 20 ACH | Calibration report, measurement logs |
| TP-02 | Measure Airflow | Within specified range | Flow meter readings |
| TP-03 | Measure Temperature | 20°C – 24°C | Temperature logs |
| TP-04 | Measure RH | 30% – 60% | Humidity logs |
| TP-05 | Check DP | Within specified limits | DP gauge readings |
| TP-06 | Verify Alarms | All alarms functional | Alarm test log |
| TP-07 | Review Trends | No anomalies | Trend analysis report |
| TP-08 | Audit Trail Review | Complete and accurate | Audit trail report |
Detailed Test Cases
TP-01: Measure ACH
Procedure: Use an anemometer to measure air changes per hour (ACH) in the classified room. Document the readings and calculate the ACH based on room volume.
Acceptance Criteria: ACH must be ≥ 20.
Evidence: Measurement logs and calculation documentation.
TP-02: Measure Airflow
Procedure: Measure airflow using calibrated flow meters at designated locations. Ensure readings are within specified operational ranges.
Acceptance Criteria: Must be within specified range.
Evidence: Flow meter readings documentation.
Deviations
Any deviations from the acceptance criteria must be documented in a deviation report and reviewed by the Quality Assurance team. Justifications for deviations must be provided and corrective actions must be implemented.
Approvals
Prepared By: [Name] Date: YYYY-MM-DD
Reviewed By: [Name] Date: YYYY-MM-DD
Approved By: [Name] Date: YYYY-MM-DD