Glossary
Aseptic Processing
Also writtenaseptic manufacturing
A process controlled so that microorganisms, endotoxin, and particles do not contaminate sterilised product, containers, and equipment while they are handled.
Source · EU GMP Annex 1 (2022), Glossary and §§2.1–2.7
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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The ISO classified aseptic processing areas have difficult to clean and visibly dirty equipment and surfaces.
FDA · FDA Warning Letter · 2021-07-27 -
Your aseptic processing areas included areas that were difficult to clean, including but not limited to, scratches on the work surfaces of all (b)(4) laminar flow hoods.
FDA · FDA Warning Letter · 2023-05-30 -
An (b)(4) line used for aseptic processing was observed to be touching the floor during (b)(4) setup activities.
FDA · FDA Warning Letter · 2025-01-21
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 and §§2.1–2.7GRM Regulatory Glossary
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