01 Overview

02 Details

BT10 is a self-contained biological indicator (SCBI) designed for monitoring sterilization cycles using Ethylene Oxide (EO). It contains non-pathogenic spores of Bacillus atrophaeus (ATCC® 9372) at a population of ~10⁶ spores per vial.
It provides a reliable check of sterilizer performance in EO sterilization processes.

INSTRUTIONS OF USE

  1. Label the indicator with sterilizer number (if more than one), load number, and processing date.
  2. Pack the BT10 indicator together with the materials to be sterilized, placing it in the location most difficult for the sterilant to reach (e.g., centre of the load or near the door).
  3. Run the EO sterilisation cycle according to your facility’s validated protocol.
  4. After sterilization, remove the indicator (after any required aeration of the load) using gloves and eye protection—do not crush or handle excessively before activation.
  5. Check the chemical indicator on the label: a change in colour (e.g., to green) confirms the indicator was exposed to EO—but this does not confirm sterility.
  6. Activate the indicator by crushing the internal ampoule, then shake the tube vigorously so the spore carrier is suspended in the medium.
  7. Incubate at ~37 °C (±2 °C) for up to 48 hours, with periodic readings (e.g., every 10 hours).
    • A colour change from blue → yellow in the growth medium indicates a sterilization failure.
    • No colour change within 48 hours indicates a successful sterilization cycle (negative result) provided the positive control has changed.
  8. Record the results, and if failure is indicated, investigate the steriliser cycle, load setup, and aeration parameters.

AREAS OF APPLICATION

  • Hospital Central Sterile Supply Departments (CSSD)
  • Medical and dental clinics using EO sterilization
  • Pharmaceutical and biotechnology facilities employing EO sterilizers
  • Process monitoring for validated EO sterilization loads

FEATURES & BENEFTS

  • Self-contained unit combining spore carrier + growth medium for simplicity and safety.
  • Specifically designed for EO sterilization processes (validated for ~10⁶ spores of Bacillus atrophaeus).
  • 48-hour read-out time allows workflow planning and load release timing.
  • Enables direct measurement of sterilisation lethality (not just chemical indicator exposure).
  • Helps facilities meet regulatory and accreditation requirements for steriliser monitoring.
  • The chemical indicator ensures exposure; the biological readout ensures process performance.

COMPOSITION

  • Spore carrier: Filter paper or suitable substrate inoculated with ~10⁶ spores of Bacillus atrophaeus (ATCC® 9372).
  • Culture medium: Enclosed ampoule containing nutrient medium with pH or growth-indicating colour change (e.g., blue to yellow) for detection of growth.
  • Vial: Polypropylene tube with cap and medical-grade filter (to allow gas exchange during incubation).
  • Label: Includes chemical process indicator ink that changes colour when exposed to EO.

Note: Exact concentrations of medium components are proprietary.

PRECAUTIONS OF USE

  • Use only for EO sterilisation monitoring; do not apply for steam, H₂O₂ plasma, dry heat or other sterilisation methods unless validated for that method.
  • Handle the biological indicator carefully: wear gloves and eye protection when removing or activating. Glass ampoule inside may burst if mishandled.
  • The chemical indicator only confirms exposure to sterilant—not full sterility—so always follow incubation and positive-control protocol.
  • Store in dry, dark conditions at suitable temperature (e.g., 10-30 °C), away from sterilising agents or chemical vapours.
  • Dispose of used indicators according to medical/sterile-process waste regulations.
  • Do not reuse indicators; use a fresh unit for each load and maintain positive controls daily.

PACKING TYPES

  • Supplied in boxes of 100 units, each unit is individually sealed and ready for use.

PRODUCT CODE

  • BT10 – Biological Indicator for Ethylene Oxide (EO), 48 hour read-out.