Procedure for HEPA Filter Integrity Testing

1) Purpose

The purpose of this SOP is to outline the procedure for conducting HEPA (High Efficiency Particulate Air) filter integrity testing to ensure air quality in cleanrooms.

2) Scope

This SOP applies to all HEPA filters installed in cleanrooms within the facility that require regular integrity testing to maintain air quality standards, following regulatory guidelines and internal specifications.

3) Responsibilities

Facility Engineering: Responsible for performing HEPA filter integrity testing.
Quality Assurance (QA) Department: Responsible for oversight and review of HEPA filter testing procedures.

4) Procedure

4.1 Pre-Testing Preparation:
    4.1.1 Schedule testing during periods of low activity to minimize airflow disturbances.
    4.1.2 Verify calibration and readiness of the aerosol generator and photometer.

4.2 Aerosol Challenge:
    4.2.1 Generate a suitable aerosol challenge using a specified aerosol generator.
    4.2.2 Introduce the aerosol upstream of the HEPA filter, ensuring uniform distribution across the filter face.
    4.2.3 Monitor aerosol concentration upstream and downstream of the filter using a calibrated photometer.

4.3 Leak Test:
    4.3.1 Perform leak testing by scanning the entire surface of the filter with the photometer probe.
    4.3.2 Record and document any deviations in aerosol concentration indicating leaks or breaches.

4.4 Data Analysis:
    4.4.1 Calculate the efficiency of the HEPA filter based on aerosol concentration measurements.
    4.4.2 Compare results against acceptance criteria defined in facility standards or regulatory guidelines.
    4.4.3 Analyze trends and deviations over time to assess filter performance and potential maintenance needs.

4.5 Documentation and Reporting:
    4.5.1 Record all testing parameters, including aerosol generation details, photometer readings, and observations.
    4.5.2 Compile results into a HEPA Filter Integrity Test Report for review by QA.
    4.5.3 Implement corrective actions as necessary based on QA review and approval.

5) Abbreviations, if any

HEPA: High Efficiency Particulate Air
QA: Quality Assurance

6) Documents, if any

HEPA Filter Integrity Test Report
Aerosol Generator Calibration Records
Photometer Calibration Records

7) Reference, if any

ISO 14644-3:2019 – Cleanrooms and associated controlled environments
FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing

8) SOP Version

Version 1.0