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Biological Indicator (BI) Testing

BIs can help demonstrate whether a sterilization process is capable of achieving the required level of microbial inactivation. 

What We Do

We determine the absence/presence of viable spores on a BI. We also verify and determine the number of viable bacterial spores on a BI or in a Liquid Suspension and to show that the population falls within the appropriate range as stated on the CofA from the manufacturer. 


  • Internal/External Process Challenge Devices (IPCD’s and EPCD’s) Testing
  • Paper strips
  • Ampules 
  • Self-contained BI’s containing Geobacillus stearothermophilus, Bacillus atrophaeus (Ethylene Oxide (EO) and Dry Heat) or other biological indicator microorganisms
  • BI enumeration or population verification tests

Why It Matters

  • Challenge sterilization processes with a known population of resistant microorganisms.
  • Support sterilization process development and validation.
  • Evaluate the effectiveness of a sterilization cycle.
  • Provide objective microbiological evidence during sterilization qualification.
  • Support ongoing monitoring of sterilization processes when appropriately incorporated into a validated program.
  • Meet USP <55>, ANSI/AAMI/ISO 11138-1 and other regulatory requirements.

BI Test Codes

BI Sterility

BI200

BI Enumeration

BI201

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