Biological indicator definition

Biological indicator means a representative microorganism used to evaluate treatment efficacy.
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Biological indicator means a representative microor- ganism used to evaluate treatment efficacy.
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Biological indicator means a commercially prepared device with a known population of highly resistant bacterial spores to test the method of sterilization being monitored. The indicator is used to demonstrate that conditions necessary to achieve sterilization were met during the cycle being monitored. Biological indicators are regulated by the FDA.
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Examples of Biological indicator in a sentence

  • Biological indicator for autoclave shall be Geobacillusstearothermophilus spores using vials or spore Strips; with at least 1X106 spores.

  • Biological indicator for autoclave shall be Bacillus stearothermophilus spores using vials or spore Strips; with at least 1X104 spores per millilitre.

  • Biological indicator: styreneACGIH - Notes: Biological limit value: 400 mg/g Kreatinina.

  • Sterilization Validation – Ethylene Oxide should include:• Protocol;• Summaries regarding commissioning of the sterilization equipment;• Validation of bioburden testing method & test report;• Bioburden determination and test reports;• Biological indicator data;• All cycle data and test reports (fractional, half, full);• Validation of product sterility testing method & test report;• Product sterility testing & test report;• Sterilant residual analysis reports.

  • Biological indicator testing of commonly encountered suspicious powders.

  • Biological indicator for autoclave shall be Bacillus stearothermophilus spores using vials or spore strips, with at least 1x104 spores per millilitre.

  • Biological indicator: Sterilization Claims should be validated using US FDA approved Biological Indicators with 30 minutes reading time.

  • Biological indicator for autoclave shall be Bacillus stearothermophilus spores using vials or spore Strips; with at least 1X104 spores per milliliter.

  • Biological indicator species don’t only specify or show the interaction of various conditions of the environment, but they should also respond to immediate change of other factors which are important (Li et al., 2010).

  • The forms will be used whenever applicable in the gen- eral operation of the program.[33 FR 5301, Apr.


More Definitions of Biological indicator

Biological indicator means a species, community or biological process used to provide qualitative and/or
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Biological indicator means a standardized viable population of migroorganisms known to be resistant to the mode of sterilization being monitored.
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Related to Biological indicator

  • Licensed Compound means [***].

  • Antibody means a molecule comprising or containing one or more immunoglobulin variable domains or any fragments, derivatives, variants or modifications thereof that bind to the same antigen.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.