Manufacturing & Sterility

HEPA Filter Integrity Test

High-Efficiency Particulate Air Filter Integrity Test

What a definition is not

A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.

A HEPA filter integrity test challenges an installed filter with an aerosol and scans the downstream face to detect leaks in the medium, frame, or seal that would let unfiltered air (and its particles/microbes) bypass the filter. It confirms not just filter efficiency but the integrity of the installation.

The most rigorous method is an in-place scan using a photometer or particle counter to traverse the entire downstream surface and frame seal with a defined challenge aerosol (e.g. PAO), detecting localized leaks a single-point efficiency test would miss. A penetration above the acceptance threshold means the filter or seal fails.

Integrity testing is distinct from airflow velocity and air-change verification; a filter can move the right volume of air yet leak. Grade A/B unidirectional and cleanroom supply filters are integrity-tested on installation and re-tested periodically.

KEY POINTS
  • Detects leaks in medium, frame, and seal — not just efficiency.
  • In-place scan with challenge aerosol and photometer/particle counter.
  • Leak acceptance typically 0.01% penetration under ISO 14644-3 / Annex 1.
  • Distinct from airflow velocity and air-change tests.
REGULATORY BASIS

ISO 14644-3 (2019) test methods; EU GMP Annex 1 (2022) filter integrity testing.

Frequently asked questions

What does HEPA Filter Integrity Test stand for?

HEPA Filter Integrity Test stands for High-Efficiency Particulate Air Filter Integrity Test.

What is HEPA Filter Integrity Test?

A HEPA filter integrity test challenges an installed filter with an aerosol and scans the downstream face to detect leaks in the medium, frame, or seal that would let unfiltered air (and its particles/microbes) bypass the filter. It confirms not just filter efficiency but the integrity of the installation.

Which regulations cover HEPA Filter Integrity Test?

ISO 14644-3 (2019) test methods; EU GMP Annex 1 (2022) filter integrity testing.