SELF-CONTAINED BIOLOGICAL INDICATORS Key Components
A plastic pipe and cap.The cap with a hole is placed on top of the pipe to allow the sterilizing agent topenetrateinto the indicator. Between pipe and cap there isa filter paper whichis used to avoid pollution.A crushable media ampule which contains modified culture medium with a pH indicator and fluorogenicsubstrates. The modified culture medium will change from the initial Purple color to Yellow in thepresence of bacterialgrowth.An inoculated carrier of Geobacillus stearothermophilus ATCC 7953 with a population level of ≧106 is located at the bottom closed end of the pipe. A barrier is positioned like a plug between the carrier andtheampule. The LBS010 Rapid Biological Indicator, when used with an automatic reader (incubation temperature 54-60℃), providesa fluorescence testresult in ashort period (LBS010-10minutes) with an accuracy of ≧97%.As an option the user can continue the incubation for 48 hours in order to confirm visually the stability orcolor change ofthe culture medium. The label on the outside ofthe plastic pipe contains a Type1 chemical indicator strip.
NOTE The Positive Control BI should show positive (automatic reader displays"十"). If the Positive Control asdoes not show signs of growth, consider the test invalid.Short excursions outside the range oftemperature recommended will not impactthe performance oftheLBS BIs. Do not use after the expiration date.Do not refrigerate.Autoclave fornot less than 30 minutes at 121℃ or per other validated disposal cycle priorto discard.If the incubation time exceeds 48 hours, ensure that the culture solution does not evaporate by sealingthe holes on the cap.Vacuum-assisted steam processes includes pre-vacuum and dynamic-air-removal saturated steamsterilization processes.
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