Biological Indicators
Biological Indicators
- Biological indicators are test systems containing viable microorganisms (usually bacterial spores) that are highly resistant to a specific sterilization process.
- They are used to directly measure the effectiveness of sterilization methods such as steam, ethylene oxide, hydrogen peroxide, or dry heat.
Core Function
- A BI is placed inside the sterilizer along with the items being sterilized.
- After the cycle, the BI is incubated to check if any spores survived.
- No growth = sterilization successful.
- Growth = sterilization failure.
Components
- Carrier: A strip, disc, or ampoule containing spores of resistant microorganisms (e.g., Geobacillus stearothermophilus for steam sterilization, Bacillus atrophaeus for ethylene oxide).
- Primary Packaging: Protects the BI during handling and sterilization.
- Culture Medium: Used after sterilization to promote growth if spores survived.
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Applications
- Healthcare & Laboratories: Validating autoclaves, sterilizers, and disinfection processes.
- Pharmaceutical & Food Industries: Ensuring sterility in production environments.
- Regulatory Compliance: Required by standards such as ISO, FDA, and WHO for sterility assurance.
Advantages
- Provide direct evidence of sterilization effectiveness (unlike chemical indicators, which only show exposure).
- Highly reliable because they use living organisms with known resistance levels.
- Essential for routine monitoring, validation, and quality assurance.
Biological indicators are the gold standard for sterilization monitoring, using resistant bacterial spores to confirm whether a sterilization process has truly destroyed all microorganisms.
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