31 Jul, 2025
Biological indicators (BIs) are specialized live microbial products used to verify the performance of sterilization equipment, validate sterilization procedures, and monitor the effectiveness of sterilization during production processes. They consist of a carrier inoculated with microorganisms that exhibit defined resistance to specific sterilization processes and are packaged for ready use.
Classification of Biological Indicators:
By Structure:
Strip Biological Indicators: Require both positive and negative controls.
Self-Contained Biological Indicators: Only require a positive control.
By Sterilization Method (ISO 11138-1:2006):
Biological indicators for ethylene oxide sterilization.
Biological indicators for moist heat sterilization.
Biological indicators for dry heat sterilization.
Biological indicators for hydrogen peroxide low-temperature plasma sterilization.
Biological indicators for formaldehyde sterilization.
By Incubation Time:
Universal Biological Indicato: Rely on pH changes in the culture medium due to microbial metabolism, detected via color change of a pH indicator. Results are typically read after 24 or 48 hours.
Rapid Biological Indicators: Utilize enzyme activity of germinated spores, detected via fluorescence. Results are usually available within 3–4 hours.
LISTER BIOMEDICAL CO.,LTD is a leading specialized provider of innovative sterilization monitoring solutions, dedicated to enhancing the safety and effectiveness of sterilization processes across various industries.
At LISTER, we are committed to advancing the field of sterilization by offering a comprehensive range of high-performance sterilization monitoring products. Our portfolio includes Biological Indicators(BIs), Chemical Indicators(CIs), Rapid Biological Auto-reader Incubators ,Process challenge device(PCD) and Bowie-Dick Test Packs, that are designed to meet the stringent demands of medical device sterilization and ensure compliance with global safety standards.
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