SELF-CONTAINED BIOLOGICAL INDICATORS Key Components
Self-Contained Biological Indicators consist of: Aplasticpipe and cap. The cap witha holeis placed on top of the pipe to allow the sterilizing agent to penetrate into the indicator. Between pipe and cap there isa filterpaper which is used to avoid pollution. Acrushable media ampule which contains modified culture medium with a pH indicator. The modified culture medium will changefrom the initial Purple color to Yellow in the presence of bacterial growth. An inoculated carrier of Geobacillus stearothermophilusATCC 7953 is located at the bottom closed end of the pipe. The LBS288BiologicalIndicator,whenusedwith anincubator (incubation temperature 56-60°C), provides a test result after 48hourwith an accuracy of ≥97%. The label on the outside of the plastic pipe contains a Type 1 chemical indicator strip.
NOTE The Positive Control Bl should show positive. lf the Positive Control as does not show signs of growthconsiderthetestinvalid. Short excursions outside the range oftemperature recommended will not impact the performance oftheLBS BIS. Do not use aftertheexpiration date.Do not refrigerate. Autoclave for not less than 30 minutes at 121'Cor per other validated disposal cycle prior to discard. If the incubation time exceeds 48 hours, ensure that the culture solution does not evaporate by sealincthe holes on the cap.
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