Glossary
High Efficiency Particulate Air (HEPA) Filter
A high efficiency air filter that removes fine particles from the air supplied to a cleanroom or aseptic working area.
Source · EU GMP Annex 1 (2022), Glossary, HEPA filter
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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HEPA filters were discolored and/or damaged in the ISO 5 cleanroom hood.
FDA · FDA Warning Letter · 2021-11-16 -
The donor specimen collected from anonymous oocyte donor (b)(6) on July 8, 2020, was not tested for human immunodeficiency virus, types 1 and 2 (HIV-1/2), hepatitis B virus (HBV), hepatitis C virus (HCV), and Treponema pallidum at the time of recovery on July 14, 2020.
FDA · FDA Warning Letter · 2021-12-14 -
A brownish residue on the protective screen of the HEPA filter within your ISO 5 aseptic processing area.
FDA · FDA Warning Letter · 2022-04-12
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
EU GMP Annex 1 (2022), Glossary, HEPA filterGRM Regulatory Glossary
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