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.

Related sections

EU GMP Annex 1 §§2–10 21 CFR 211.42 21 CFR 211.113

Related terms

Cleanroom146 casesCleanroom Classification1 casesEnvironmental Monitoring138 cases

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

  1. HEPA filters were discolored and/or damaged in the ISO 5 cleanroom hood.
    FDA · FDA Warning Letter · 2021-11-16
  2. 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
  3. 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
See 1 findings that mention this term

Source

EU GMP Annex 1 (2022), Glossary, HEPA filter
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