Glossary

Aseptic Processing

A process controlled so that microorganisms, endotoxin, and particles do not contaminate sterilised product, containers, and equipment while they are handled.

Related sections

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

Related terms

Aseptic Process Simulation (APS, Media Fill)29 casesContamination Control Strategy (CCS)8 casesSterility Assurance Level (SAL)2 cases

Real inspection findings

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

  1. The ISO classified aseptic processing areas have difficult to clean and visibly dirty equipment and surfaces.
    FDA · FDA Warning Letter · 2021-07-27
  2. 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
  3. 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
See 1,530 findings that mention this term

Source

EU GMP Annex 1 (2022), Glossary and §§2.1–2.7
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