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Biological Indicator Sterility Testing

Biological Indicator Sterility Testing

Biological Indicators (BIs) are widely used to monitor the efficacy of sterilization processes. BIs provide a high level of sterility assurance and are ideal monitors of the sterilization process. The BI Sterility test is performed on exposed BIs after completion of a sterilization load through either a validation or routine lot release monitoring. The test is qualitative which yields results of either growth or no growth of the appropriate indicator organism.

The test is performed on BIs subjected to different types of sterilization such as ethylene oxide, steam, dry heat, vapor phase hydrogen peroxide and ozone, as well as other novel processes. Both traditional BIs and self-contained BIs may be tested. This test is typically performed during validation as well as during routine production as a lot release test.

BI testing and sample requirements are outlined in numerous standards including USP <55>, the ANSI/AMMI/ISO 11138 series parts 1-4, ANSI/AAMI/ISO 14161 and ANSI/AAMI/ISO 11135.

Nelson Laboratories offers BI testing 7 days a week, 365 days a year with no holiday or weekend fees. Samples are tested immediately upon arrival and the final reports are uploaded to our secure website the same day BIs are released from incubation by 10:30AM (MST) from Monday to Friday.

Applicable Standards

  • ISO 11135

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
BIT210 BI Sterility: Immersion, Spore Strips (7 Day), Each 9 Add
BIT230 BI Sterility: Self-contained biological indicators, Each 5 Add
BIT310 Spore Strip Survivor Time Verification, EO Bier 14 Add
BIT320 Spore Strip Survivor Time Verification, Steam Bier 14 Add
BIT330 Spore Strip Survivor Time Verification, Other Method or Quantity 14 Add
BIT410 Spore Strip Kill Time Study, EO Bier 14 Add
BIT420 Spore Strip Kill Time Study, Steam Bier 14 Add
BIT710 BI Sterility: Standard BI Minimum Test Fee 8 Add
BIT715 BI Sterility: Self-Contained BI Minimum Test Fee 7 Add
BIT210 - BI Sterility: Immersion, Spore Strips (7 Day), Each
9 days
BIT230 - BI Sterility: Self-contained biological indicators, Each
5 days
BIT310 - Spore Strip Survivor Time Verification, EO Bier
14 days
BIT320 - Spore Strip Survivor Time Verification, Steam Bier
14 days
BIT330 - Spore Strip Survivor Time Verification, Other Method or Quantity
14 days
BIT410 - Spore Strip Kill Time Study, EO Bier
14 days
BIT420 - Spore Strip Kill Time Study, Steam Bier
14 days
BIT710 - BI Sterility: Standard BI Minimum Test Fee
8 days
BIT715 - BI Sterility: Self-Contained BI Minimum Test Fee
7 days

Sample Specifications

BIT210: The number of BIs should be based on ISO11135-1:2007 recommendations regarding product volume.
BIT230: The number of BIs should be based on ISO11135-1:2007 recommendations regarding product volume.
BIT310: Minimum 50 BIs for ISO, minimum 20 for USP
BIT320: Minimum 40 BIs
BIT410: Minimum 50 BIs for ISO, minimum 20 for USP
BIT420: Minimum 40 BIs

Study Outline

In the Biological Indicator Sterility test, BIs are aseptically placed into soybean casein digest broth and incubated for the appropriate time and temperature, depending on the growth requirements for the indicator organism. The samples are typically incubated for 7 days at 30–35°C for Bacillus atrophaeus (EO or dry heat processes) or 55–60°C for Geobacillus stearothermophilus (steam or vaporized hydrogen peroxide processes). Other incubation conditions depend on the BI manufacturer’s instructions.

Clients may perform testing for a shorter release time by following  the FDA (CDRH) guidance for Spore Strip Reduced Incubation Time (RIT) validation. Nelson Laboratories performs reduced incubation time validations and can assist you in shortening incubation times in order to release a product to market sooner.

Note: BIT210 is subject to a minimum test fee. See BIT710 above for pricing.
Note: BIT230 is subject to a minimum test fee. See BIT715 above for pricing.