biological indicator
- Guideline or reference source
- FDASDP Sterile drug products produced by asceptic processing - CGMP
- Definition
- A population of microorganisms inoculated onto a suitable medium (e.g., solution, container or closure) and placed within appropriate sterilizer load locations to determine the sterilization cycle efficacy of a physical or chemical process. The challenge microorganism is selected based upon its resistance to the given process. Incoming lot D-value and microbiological count define the quality of the BI.
- Abbreviation for
- BI
- Broader Term
- indicator
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