Biological Indicators for Sterility Assurance | STERIS
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Biological Indicators for Sterilization

Biological indicators (BIs) provide information on whether necessary conditions were met to kill a specified number of microorganisms (bacterial spores) for a given sterilization process. STERIS's complete portfolio of biological indicators offers testing for various applications, including steam sterilization and vaporized hydrogen peroxide (VH2O2) sterilization. Geobacillus stearothermophilus spores are mainly used in these applications due to their high resistance to these sterilization processes.

BIs are typically used within process challenge devices (PCD), designed to represent the most challenging products routinely processed for sterilization testing. A passing result for the BI within the PCD demonstrates that the sterilization cycle effectively inactivates the BI, providing Sterile Processing Department staff with assurance in their steam or VH2O2  sterilization process.

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Celerity 5 HP Biological Indicator - Results in 5 Minutes

BIOLOGICAL INDICATORS FOR STEAM STERILIZATION

STERIS biological indicators for steam sterilization include self-contained biological indicators (SCBI) and process challenge devices or test packs. These devices play a crucial role in sterility assurance and provide the only direct measure of the lethality of the sterilization process. Browse steam sterilization biological indicators by read times, compatible autoclave cycles, and key features and benefits.

Celerity 20 Steam BI

Celerity™ 20 Steam Biological Indicator

  • Read Time: Fast 20-minute results – fastest STEAM BI on the market
  • Cycles: Common Dynamic Air Removal (Prevac/SFPP) & Gravity Cycles
  • Feature: Glass-free twist and flick activation + integrated barcode label for electronic documentation

Celerity 20 Steam Process Challenge Device

Celerity™ 20 Steam Process Challenge Device

  • Read Time: Fast 20-minute BI results and clear plastic housing allow for quick interpretation
  • Cycles: Common Dynamic Air Removal (Prevac/SFPP) & Gravity Cycles
  • Feature: Compact PCD providing equivalent performance to ANSI/AAMI 16-towel test

Celerity 20 STEAM IUSS Biological Indicator

Celerity™ 20 Steam Biological Indicator for IUSS

  • Read Time: Quick device turnaround with results in just 20 minutes
  • Cycles: Validated for commonly used gravity IUSS cycles
  • Feature: Integrated barcode assists with electronic documentation

Celerity Xtend

Celerity™ Xtend 10 Assembly

  • Read Time: Biological Indicator (BI) Test Pack validated for extended 10-minute cycles
  • Cycles: Validated for use only with the VERIFY All-In-One STEAM Reusable Test Pack
  • Feature: Remain compliant with device Instructions For Use that require 10-minute cycles

VERIFY Assert Self-Contained Biological Indicator

VERIFY™ Assert™ Self-Contained Biological Indicator

  • Read Time: Provides results in 40 minutes
  • Cycles: Common Dynamic Air Removal (Prevac/SFPP) & Gravity Cycles
  • Feature: Glass-free twist and flick activation + integrated barcode label for electronic documentation

VERIFY Assert Steam Process Challenge Device

VERIFY™ Assert™ Steam Process Challenge Device

  • Read Time: 40-minute BI results and clear plastic housing allow for quick interpretation
  • Cycles: Common Dynamic Air Removal (Prevac/SFPP) & Gravity Cycles
  • Feature: Compact PCD providing equivalent performance to ANSI/AAMI 16-towel test

Biological Steam

VERIFY™ Biological STEAM Test Pack

  • Read Time: Provides results in 24 hours
  • Cycles: Dynamic Air Removal Cycles at 270°F/132°C and Gravity Cycles at 250°F/121°C
  • Feature: Equivalent performance to ANSI/AAMI 16-towel test pack

BI Challenge pack

VERIFY™ Biological/Integrator Challenge Pack

  • Read Time: Provides results in 24 hours
  • Cycles: Dynamic Air Removal Cycles at 270°F/132°C and Gravity Cycles at 250°F/121°C
  • Feature: Type 5 chemical integrator meets ANSI/AAMI/ISO 11140-1 requirements

Dual

VERIFY™ Dual Species Self-Contained Biological Indicators

  • Read Time: Provides results in 24 hours for steam and 48 hours for ethylene oxide (EO)
  • Cycles: Ethylene oxide sterilizers and various steam sterilizer cycles
  • Feature: Vivid color change of growth media to indicator microbial growth 
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V-PRO™ or STERRAD™ Sterilization

Browse STERIS biological indicators for use in V-PRO™ Low Temperature Sterilization Systems or STERRAD™ Models. Single-use biological indicators help monitor vaporized hydrogen peroxide (VH2O2) sterilization processes, while challenge packs are used during qualification testing of V-PRO sterilizers. With the Celerity HP Biological Indicator, you can get BI results in as little as 5 minutes!

Learn more about the Celerity 5 HP Biological Indicator today!

STERIS BI and Incubator 18347

Celerity™ HP Biological Indicators

  • Read Time: Celerity 5 HP Biological Indicator provides results in just 5 minutes, and the Celerity 20 HP Biological Indicator provides results in 20 minutes
  • Cycles: Single-use, rapid readout biological indicator for use with V-PRO™ Low Temperature Sterilization Systems and STERRAD™ Systems*
  • Features: Innovative glass-free design, requiring no separate activator

Celerity 20 HP Challenge Pack

Celerity™ HP Challenge Packs

  • Read Time: Provides biological indicator results in as little as 5 minutes
  • Cycles: Used for qualification of V-PRO™ Low Temperature Sterilizers in about 3 hours
  • Feature: Challenge pack includes a Celerity™ HP Biological Indicator, a chemical indicator, and a blue polyurethane foam sheet

V24

VERIFY™ v24 Self-Contained Biological Indicator

  • Read Time: Provides results in 24 hours
  • Cycles: For use with V-PRO™ Low Temperature Sterilization Systems and STERRAD™ Models*
  • Feature: Self-contained biological indicator with a Type 1 chemical indicator

V24 Challenge pack

VERIFY™ v24 Challenge Pack

  • Read Time: Provides results in 24 hours
  • Cycles: Used for qualification of V-PRO Low Temperature Sterilization Systems
  • Feature: Preassembled biological indicator challenge pack
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Biological Indicator Incubators

Incubators play a crucial role in the sterility assurance process by testing if all viable organisms in the biological indicator test vial have been eliminated. The incubator heats the activated BIs to temperatures that promote the metabolism and subsequent detection of viable test organisms under evaluation.

In most modern incubators, while the activated BI is incubating, viability is determined by an increase in a fluorescent signal from the enzymatic breakdown of a fluorogenic substrate in the media. Once initiated, each well independently monitors the potential fluorescence generated from the activity of α-glucosidase within the BI. Detection of a fluorogenic substrate following catalysis by α-glucosidase indicates a positive response, while the absence of fluorescence produces a negative result. A negative result indicates that all viable organisms in the test vial have been eliminated. Modern incubators will show the results to the user audibly and visually within each BI's validated readout time.

Celerity Incubator.

Celerity™ Incubator

  • Universal incubator for use with both Celerity™ STEAM and VH2O2 Biological Indicators
  • Compact design requires minimal workspace while holding up to eight biological indicators
  • Connectivity allows for electronic record keeping and integration with tracking systems

Celerity Steam Incubator

Celerity™ STEAM Incubator

  • Provides fast results of the Celerity™ 20 STEAM Biological Indicator in only 20 minutes
  • Audio and visual alarms aid in easy results interpretation
  • Offers electronic record keeping capabilities to assist with audits

Celerity HP Incubator

Celerity™ HP Incubator

  • Designed exclusively to incubate and read activated Celerity™ 20 HP Biological Indicators
  • Provides a final readout within 20 minutes
  • Audio and visual alarms for easy interpretation of results

VERIFY Incubator for Assert Self-Contained Biological Indicators

VERIFY™ Incubator for Assert™ Self-Contained Biological Indicators

  • Designed exclusively to incubate and read activated VERIFY™ Assert™ Biological Indicators
  • Holds up to 8 VERIFY™ Assert™ Steam Biological Indicators
  • LCD screen provides a clear interpretation of results

Incubators

VERIFY™ Incubators

  • For use with VERIFY™ Biological Indicators
  • Tabletop incubator for select steam, VH2O2, and EO biological indicators
  • Available in 6 or 28-well capacity or a 28 well dual temperature incubator

* STERRAD™ is a trademark of ASP Global Manufacturing, GmbH.

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