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HEPA Filter Integrity Test-Why, when, and how to test?

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HEPA Filter Integrity Test-Why, when, and how to test?

2024-07-05 11:00:00

HEPA filters generally refer to the filters with a collection efficiency of more than 99.97% for particles with a particle size0.3μm. They will be installed in important zones to filter air supply and exhaust, and make sure the cleanliness in controlled environment meets design requirements.

The HEPA filter integrity test is usually conducted on supply air or exhaust air HEPA filters using a photometer to scan the filter surface for leaks.

Why should HEPA filters be tested?

HEPA filters are installed in the Filter Box by clamping. When installing, the filter may be damaged or the sealing strip may fail because of impropriate installation. A damaged surface or broken seal can cause a leak. These leaks could allow the transmission of contaminant particles that would be unacceptable in a critical application.
To maintain the proper functioning of your filters, your facility should conduct testing and regular maintenance.

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When should HEPA filters be tested?
Once the filter is installed, integrity test should be conducted to make sure it is functional. Besides, integrity test is also a routine for cleanroom maintenance. According to ISO standard, test should be performed every six months in Class 1-5 zones and every twelve months in Class 6-9 environments. Of course, if the filter doesn't pass the test, it must be replaced. 

shangchuan_01.jpgRelated Standards

  • ISO 14644 Cleanrooms and associated controlled environments
  • GMP ——Good manufacturing practice of medical products

How to do the HEPA filter testing?

The most common and popular HEPA filter testing method is the "Aerosol Photometer Method."

Leakage testing involves comparing the concentration in upstream of the filter to the concentration in downstream. It is essential to measure the upstream concentration of the introduced aerosol. 

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Upstream –Aerosol Generator and Photometer

Cold aerosol challenge (PAO) is commonly utilized for scanning filters to detect leaks. PAO aerosol is produced using an aerosol generator with Laskin nozzle. Then test the upstream concentrations by using an aerosol photometer.

The ISO 14644-3 standard recommends concentrations between 1µg/l and 100µg/l for aerosol photometer method. Lower concentrations reduce sensitivity, while higher concentrations increase the chance of fouling the filter. 

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               Aerosol Photometer ZR-6012   &  Aerosol Generator ZR-1300A

Downstream –Aerosol Photometer
Using an aerosol photometer to detect the concentration of aerosols downstream of the filter to determine if there is leakage in the filter.