SELF-CONTAINED BIOLOGICAL INDICATORS Key Components
Self-Contained Biological Indicators for monitoring steamsterilization consist of:
A plastic pipe and cap.The cap with a hole is placed on top ofthe pipeto allow the sterilizing agent to penetrateinto the indicator. Betweenpipe and cap thereis aflter paper which is used to avoid pollution.
A crushable media ampule which contains modifed culture mediumwith a pH indicator.
The modifed culture medium will change fromtheinitial Purple colortoYellowin the presence ofbacterial growth.
An inoculated carrier of Geobacillus stearothermophilus ATCC 7953with a population level of≥10, is located at the bottom closed end ofthe pipe.
The LBS144 /LBS288 Biological Indicator, when used with anincubator (incubation temperature 54-60'C), provides a test resultafter24hours(LBS144)or48hours(LBS288)with an accuracyof≥97%.
The label on the outside ofthe plastic pipe contains aType 1 chemicaindicator 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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