Glossary

Biological Indicator

A test piece carrying microorganisms of known resistance to a sterilisation process, used to confirm the effectiveness of a sterilisation cycle.

Related sections

Related terms

Real inspection findings

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

  1. Biological indicators were not used to verify the adequacy of the sterilization cycle.
    FDA · FDA 483 · 2024-01-17
  2. Biological indicators are not used to verify the adequacy of the sterilization cycle of <Redacted B4> to sterilize your firm's glassware used in sterile operations.
    FDA · FDA 483 · 2024-01-17
  3. Biological indicators are not used properly to verify the adequacy ofthe sterilization cycle.
    FDA · FDA 483 · 2024-01-17
See 9 findings that mention this term

Source

식품의약품안전처, 「알기 쉬운 GMP 용어집」, Biological Indicator; EU GMP Annex 1