Standard Operating Procedure for HEPA Filter Integrity Testing

1) Purpose

This SOP outlines the procedures for conducting HEPA filter integrity testing in cleanrooms or controlled environments.

2) Scope

This SOP applies to HEPA filter integrity testing conducted in cleanrooms or areas where high-efficiency particulate air (HEPA) filters are used for air filtration.

3) Responsibilities

The Facilities or Engineering department is responsible for performing HEPA filter integrity testing. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the HEPA filter integrity testing protocol and ensure all necessary materials and equipment are available (e.g., aerosol generator, photometer).
2. Verify the calibration and functionality of the aerosol generator and photometer.

4.2 Testing Setup

1. Prepare the cleanroom or controlled environment for testing by ensuring it is in the operational state.
2. Isolate the area under test to prevent contamination during testing.

4.3 Testing Procedure

1. Generate a specified aerosol challenge using the aerosol generator.
2. Introduce the aerosol challenge upstream of the HEPA filter.
3. Scan the downstream side of the HEPA filter with the photometer to measure aerosol penetration.
4. Compare the photometer readings against acceptance criteria to determine filter integrity.
5. Perform HEPA filter integrity testing in accordance with regulatory requirements and facility procedures.

4.4 Acceptance Criteria

1. Ensure that the HEPA filter passes the integrity test based on specified acceptance criteria for aerosol penetration.
2. Document any deviations from acceptance criteria and investigate root causes if necessary.

4.5 Reporting and Documentation

1. Document all testing activities, including results and any deviations, in the appropriate logbooks and records.
2. Prepare a HEPA filter integrity testing report summarizing the findings for each test conducted.
3. Review and approve the testing report to ensure accuracy and compliance with regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure
HEPA: High-Efficiency Particulate Air
QA: Quality Assurance

6) Documents, if any

HEPA Filter Integrity Testing Protocol, Testing Records, Testing Reports

7) Reference, if any

Regulatory guidelines such as ISO 14644-3:2019 Cleanrooms and associated controlled environments – Part 3: Test methods, European Pharmacopoeia (Ph. Eur.) 5.1.10 Guidance on the use of HEPA filters in clean rooms

8) SOP Version

Version 1.0