Glossary

Isolator

Equipment whose interior can be reproducibly decontaminated and which continuously separates a Grade A working zone from the surrounding environment and the operator.

Related sections

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

Related terms

Restricted Access Barrier System (RABS)8 casesAseptic Processing1,530 casesContamination Control Strategy (CCS)8 cases

Real inspection findings

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

  1. The 1999 and 2000 HEPA filter integrity tests for the Isolators document that there a were “no leaks detected”.
    FDA · FDA 483 · 2024-01-17
  2. The Sterility Test Isolators were qualified and validated on 3/26/07 and 4/2/07.
    FDA · FDA 483 · 2024-01-17
  3. The company did not validate and/or monitor isolator technology.
    HC · Health Canada Inspection · 2021-09-20
See 9 findings that mention this term

Source

EU GMP Annex 1 (2022), Glossary, Isolator
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