Rapid Self-Contained Biological Indicator for EO, 4h Results, 50/box

• Rapid 4-Hour Readout, Fluorescence-based readout
• UV light stimulation detects Bacillus atrophaeus spore viability post-sterilization.
• Single-use Self-Contained Biological Indicators (SCBI) comprising a polypropylene tube, a spore carrier, and a glass ampoule with culture medium.
• Components enclosed with a colored cap, emphasizing the design for one-time use.
• Spore Population and Ethylene Oxide Indicator:
  • Each tube contains a population of Bacillus atrophaeus ATCC® 9372 spores inoculated on a spore carrier.
  • Features a Process Indicator on the label that changes color (brown/bordeaux to green) when exposed to Ethylene Oxide, serving as a visual confirmation of sterilization exposure.
• Barrier Permeable to Ethylene Oxide:
  • The plastic cap with holes and a barrier is permeable to Ethylene Oxide.
  • Highlights the device's ability to allow the penetration of Ethylene Oxide, a crucial aspect for effective sterilization.
• Visual Confirmation at 48 Hours:
  • Optional 48-hour visual color-change confirmation.
  • Green to yellow indicates living spores, while blue confirms successful sterilization.

• Optional 7-Day Readout:
  • Optional 7-day readout for initial validation, comparing results with 4-hour fluorescence data.
  • Humidified environment needed to prevent medium drying if 7-day readout performed.
• Monitoring Frequency:
  • Adheres to professional standards for monitoring sterilization loads.
  • Emphasizes the use of appropriate biological indicators for optimal patient safety.
• Shelf Life and Expiration:
  • 2-year shelf life from manufacture under recommended storage.
• Endpoint Stability Reaction:
  • Chemical indicator endpoint remains stable for a minimum of 6 months under recommended conditions.
  • SCBI (BT110) serves as a self-contained Biological Indicator with 10^6 Bacillus atrophaeus spores, monitoring ethylene oxide sterilization processes.

Type: Sterilizer

• 50 Biological Indicators per box

1. Labeling SCBI

   • Identify SCBI with sterilizer number, load number, and processing date.

2. Packaging and Placement

   • Pack SCBI with materials for sterilization, placing it in less exposed areas.

3. Sterilization Process

   • Carry out standard sterilization procedures.

4. Post-Sterilization Steps

   • After sterilization, open the door, wait five minutes, and carefully remove SCBI.
   • Caution: Wear safety glasses and gloves.
   • Warning: Avoid excessive handling to prevent glass ampoule bursting. Let SCBI cool to room temperature.

5. Process Indicator Check

   • Check the Process Indicator on the SCBI label. A color change to green indicates exposure to Ethylene Oxide.
   • Note: Color change doesn't confirm sterility; further checks on the sterilization process are necessary if no change occurs.

6. Sealing and Ampoule Crushing:

   • Press the lid to seal the tube and crush the ampoule using an individual ampoule crusher or one within the incubator.
   • Vigorously shake the tube to ensure the medium fully soaks the spore carrier.
• Important: Use a non-sterilized SCBI as a positive control daily. Ensure both controls are from the same batch.

1. Positive Control and Incubation:

   • Use a non-sterilized SCBI as a positive control daily during sterilization cycles.
   • Incubate both the processed and positive control indicators in Terragene® Bionova® Auto-reader incubators for a maximum of 4 hours.
   • Fluorescence detection within 4 hours indicates sterilization failure; positive control should give a positive fluorescence readout.

2. Incubation and Results Recording:

   • Incubate SCBIs for a pH color change if humidity is low (<35%) for potential extended fluorescent readout times.
   • Record positive results promptly and discard SCBIs as indicated.