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 Labs offers BI testing 6 days a week. 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
Testing Locations
- Salt Lake City, UT, USA
- Itasca, IL, USA
- Ontario, CA, USA
- Mexico City, Mexico
- Petit-Rechain, Belgium
- Somercotes, England
- Rantigny, France
- Wiesbaden, Germany
- Shanghai, China
Learn more aboutour locations and their certifications.
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 Labs 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.
If you have additional questions about Biological Indicators (BIs) Sterility test services, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.
FAQs
SteriTestTM steam biological indicators for monitoring steam sterilization consist of a thermoplastic vial and a brown cap, a crushable glass ampoule with tryptic soy broth (TSB) modified with pH indicator, and a disc inoculated with Geobacillus stearothermophilus spores.
What are biological indicators in sterile processing? ›
Biological indicators are test systems that contain viable microorganisms with a defined resistance to a specific sterilization process. They help monitor whether the necessary conditions were met to kill a specified number of microorganisms for a given sterilization process.
How do you test for biological indicators? ›
Biological Indicator Testing Procedure
The BI is exposed to the sterilization process and then incubated under defined growth conditions to determine whether any spores survived the process. If no spores survive, none grow and the test is a pass. If growth is detected, the test is a fail.
Which biological indicator should be used to test ethylene oxide sterilizer efficacy? ›
For the validation study, biological indicators (B.I.s) are used to challenge EO cycles. The indicator organism is Bacillus atrophaeus (formerly subtilis var. niger), a spore forming bacteria with well characterized resistance to the EO sterilization process.
What is the most commonly used biological indicator? ›
What are the Most Used Biological Indicators? Steam Biological Indicators are among the most commonly used BIs, primarily because autoclaves are widely employed for sterilization in various industries.
What are the three biological indicators? ›
Within this framework, there are three main functions of bioindicators: 1. to monitor the environment (i.e., physical and/or chemical changes), 2. to monitor ecological processes, or 3. to monitor biodiversity.
How often should biological indicators be used for sterilization? ›
CDC recommends that dental health care personnel monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e., biological indicator and control from same lot number).
What are the three types of sterilization indicators? ›
6 ISO Types of Chemical Indicators for Steam Sterilization
- Type 1: Process Indicators.
- Type 2: Specific-Use Indicators.
- Type 3: Single-Variable Indicators.
- Type 4: Multi-Variable indicators.
- Type 5: Integrating Indicators (Integrators)
- Type 6: Emulating Indicators (Cycle Verification Indicators)
Type 5. Integrating indicator. (Internal) Responds to all critical parameters of the sterilization process (time, temperature, and pressure.) The stated values are generated to be equivalent to, or exceed, the performance requirements for biological indicators.
What is a positive biological indicator test? ›
Using biological indicators in the autoclave steam sterilization process helps validate that the conditions to kill microorganisms were met. The BI is exposed to the sterilization process and then incubated to determine whether any endospores survive. If no spores survive or grow, the test is a pass.
STERIS biological indicators are available in two different species of spores, Bacillus atrophaeus for ethylene oxide (EO) and dry heat applications, and Geobacillus stearothermophilus for steam sterilization applications.
How do you activate biological indicators? ›
For internal biological indicator testing:
- Crush and activate the test vials using the SGM crusher, by placing them upright into it and gently squeezing the crusher to break the glass culture medium ampoule inside.
- Immediately place all activated vials in the EZ Test incubator and incubate for 24 hours.
A biological indicator that is incubated without being sterilized is called a positive control.
What are biological indicators for sterilization FDA? ›
A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.
What is the best method to verify sterilization? ›
Verification activities used to monitor and control the sterilization process may include: bioburden testing, Biological Indicator (BI) testing, Chemical Indicator (CI) testing, process control record review, sterilant residue testing, and endotoxin testing.
What are the biological indicators in Sterikon? ›
Sterikon® plus bioindicators can be used to test the functionality of autoclaves (15 minutes at 121 °C). They can also be used to check any sort of autoclave load for the success of sterilisation. For example, pharmaceuticals, particularly products in ampoules, canned food etc.
What are the indicators of a biological incident? ›
Biological incidents (indicators)
Unusual number of sick and dying – Casualties may occur minutes to hours to days or weeks after an incident has occurred. The time required before symptoms are observed is dependent on the agent used. Unscheduled and unusual spray – Especially outdoors during periods of darkness.
What is the biological indicator for autoclave Geobacillus stearothermophilus? ›
The presence of Geobacillus stearothermophilus spores is detected by a visual color change (media turns yellow). The yellow color change indicates a sterilization process failure.
