Design Qualification Protocol for AHU in Aseptic Area
Document Control Number: DQ-AHU-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective
The objective of this Design Qualification (DQ) protocol is to validate the Air Handling Unit (AHU) for the Aseptic Area, ensuring that it meets the specified requirements for HVAC systems serving classified rooms in sterile injectable manufacturing.
Scope
This protocol applies to the validation of the AHU serving the Aseptic Area within the Engineering Department. It encompasses all critical parameters that impact product quality and compliance with regulatory standards.
Responsibilities
The responsibilities for this DQ protocol are assigned as follows:
- Validation Team: Responsible for executing the validation activities and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for providing technical support and necessary documentation for the AHU.
Prerequisites
Prior to executing this DQ protocol, the following prerequisites must be met:
- Completion of the User Requirement Specification (URS).
- Installation and commissioning of the AHU must be completed.
- All relevant documentation (SOPs, manuals) must be available.
Equipment Description
The Air Handling Unit (AHU) is a critical utility system designed to provide controlled airflow, temperature, and humidity for the Aseptic Area. It includes features for monitoring parameters such as Air Changes per Hour (ACH), airflow, temperature, relative humidity (RH), differential pressure (DP), alarms, trends, and audit trails.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify ACH and airflow rates | ACH meets URS requirements | Calibration certificates, test reports |
| T2 | Measure temperature and RH | Temperature and RH within specified limits | Data logs, calibration reports |
| T3 | Check DP across filters | DP within acceptable range | Test reports, maintenance records |
| T4 | Review alarm and trend functionalities | All alarms function correctly and trends are logged | System logs, alarm test results |
Detailed Test Cases
Test Case T1: Verify ACH and Airflow Rates
Procedure: Use calibrated anemometer to measure airflow at various locations.
Acceptance Criteria: ACH must meet the URS requirements.
Evidence: Documented readings and calibration certificates.
Test Case T2: Measure Temperature and RH
Procedure: Measure temperature and RH using calibrated sensors.
Acceptance Criteria: Temperature must be within 20-24°C and RH must be 30-60%.
Evidence: Data logs and calibration reports.
Test Case T3: Check DP Across Filters
Procedure: Measure DP using manometer across pre-filters and HEPA filters.
Acceptance Criteria: DP must be within 0.5-1.5 inches of water column.
Evidence: Test reports and maintenance records.
Test Case T4: Review Alarm and Trend Functionalities
Procedure: Conduct alarm tests and review trend data.
Acceptance Criteria: All alarms must trigger and trends must be correctly logged.
Evidence: System logs and alarm test results.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A formal deviation report must be submitted for review and approval.
Approvals
This protocol requires the following approvals:
- Validation Team Lead: ____________________ Date: __________
- Quality Assurance Manager: _______________ Date: __________
- Engineering Manager: ____________________ Date: __________
Data Integrity Checks
Practical data integrity checks relevant to this stage include:
- Verification of data entry procedures to ensure accuracy.
- Regular audits of data logs to ensure completeness.
- Access controls to prevent unauthorized changes to critical parameters.