Glossary
Cleanroom
A room designed and operated to control airborne particle concentration and to reduce the introduction, generation, and retention of particles and microorganisms.
Source · EU GMP Annex 1 (2022), Glossary, Cleanroom
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Regarding the (b)(4) totes used to transfer materials from non-classified areas into the ISO (b)(4) cleanroom suite, your response referenced an existing CAPA for CV and you also noted that updated studies were initiated.
FDA · FDA Warning Letter · 2025-11-25 -
Your firm did not disinfect materials during transfer from the ISO 7 cleanroom into the ISO 5 hood.
FDA · FDA Warning Letter · 2023-08-08 -
Your responses to Observation 3B include a Maintenance report from July 29, 2022 – July 31, 2022, where multiple repairs and updates to the cleanroom and LFHs were documented.
FDA · FDA Warning Letter · 2023-05-30
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, CleanroomGRM Regulatory Glossary
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