Biological Indicators (BI) are widely used to monitor the effectiveness of sterilization processes. BIs provide a high level of sterility assurance and are ideal monitors of the sterilization process. BI Sterility testing is performed on open BIs after completion of the sterilization load through a validation or routine lot drop monitoring. The test is qualitative, which does not result in the growth or growth of the appropriate indicator organism.
The test is performed on BIs that are subjected to different types of sterilization and other new processes, such as ethylene oxide, steam, dry heat, vapor phase hydrogen peroxide, and ozone. Both traditional BIs and standalone BIs can be tested. This test is typically performed during validation and also during routine production as a lot release test.
BI testing and specimen requirements are specified in various standards, including USP <55>, ANSI / AMMI / ISO 11138 series parts 1-4, ANSI / AAMI / ISO 14161 and ANSI / AAMI / ISO 11135.
EUROLAB Offers BI testing 7 days a week, 365 days a year with no holiday or weekend fees. Samples are tested immediately upon arrival and BIs are removed from incubation Monday through Friday.
In the Biological Indicator Sterility test, BIs are aseptically placed in soybean casein digestion water and incubated at the appropriate time and temperature depending on the growth requirements for the indicator organism. Samples are typically incubated for 7 days at 30-35 ° C for Bacillus atrophaeus (EO or dry heat treatments) or Geobacillus stearothermophilus (steam or evaporated hydrogen peroxide processes) for 55-60 ° C. Other incubation conditions depend on BI manufacturer's instructions.
Customers can test for a shorter release period by following FDA (CDRH) guidelines for Spore Strip Reduced Incubation Time (RIT) validation. EUROLAB reduces incubation time verifications and can help you shorten incubation times to get a product to market sooner.
EUROLAB, with its highly expert team and internationally accredited laboratories, Biological Indicator - Sterility Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
