01 Overview

02 Details

BT91 is a self-contained biological indicator (SCBI) designed specifically for monitoring sterilisation cycles using vaporised or plasma hydrogen peroxide (H₂O₂).
It contains spores of Geobacillus stearothermophilus (ATCC 7953) with a labelled population (~10⁵-10⁶ CFU per unit).

INSTRUTIONS OF USE

  1. Write the steriliser number (if multiple), load number, and processing date on the BT91 label.
  2. Place the BT91 indicator within the load/package to be sterilised—ideally in the most challenging location for the sterilant (e.g., centre of the load or near door).
  3. Perform the hydrogen peroxide sterilisation cycle per validated protocol.
  4. After cycle completion, remove the indicator from its package.
  5. Check the chemical indicator on the label: a colour change (to green) shows exposure to H₂O₂, but does not confirm sterilisation.
  6. Activate the indicator by crushing the glass ampoule inside the vial, mixing the sterile carrier with the growth medium.
  7. Incubate the indicator at 55-62 °C (commonly 60 °C) for up to 24 hours.
    • If the medium remains purple, this indicates that no viable spores remain — successful sterilisation.
    • If the medium changes to yellow, this indicates live spores — sterilisation failure.
  8. Record the result. If the result is positive (i.e., medium changed), investigate the steriliser cycle, load set-up, or sterilant penetration.a

AREAS OF APPLICATION

  • Hospitals’ Central Sterile Supply Departments (CSSDs) that use plasma or vaporised H₂O₂ sterilisers.
  • Dental, surgical, and medical clinics with H₂O₂ sterilisation systems.
  • Pharmaceutical or biotech clean-rooms utilising vaporised H₂O₂ for sterilising equipment or enclosures.
  • Any facility where thorough monitoring of H₂O₂ sterilisation lethality is required.

FEATURES & BENEFTS

  • Dedicated for H₂O₂ vaporised/plasma sterilisation — ensures the correct sterilant method is monitored.
  • Self-contained unit: spore carrier + growth medium in one vial — simplifies handling and reduces cross-contamination risk.
  • Rapid read-out time of 24 hours for effective cycle monitoring and quicker feedback.
  • Colour indicator in the growth medium allows visual interpretation (purple → yellow) of sterility challenge.
  • Compliant with international standards (e.g., ISO 11138-1) for biological indicators.
  • Helps facilities meet regulatory/quality requirements for verifying steriliser lethality.
  • Enables identification of failed sterilisation cycles before the load is released for patient use.

COMPOSITION

  • Inoculated spore carrier: Geobacillus stearothermophilus (ATCC 7953) spores on the inner base of the plastic tube.
  • Glass ampoule containing growth/indicator medium (initially purple dye).
  • Plastic (polypropylene) tube with cap and vent filter.
  • Label with chemical exposure indicator (changes to green when exposed to H₂O₂).
  • Exact concentrations and formulations are proprietary.

PRECAUTIONS OF USE

  • Use only for vaporised/plasma hydrogen peroxide sterilisation cycles; do not use BT91 for steam, ethylene oxide (EO), dry heat, formaldehyde, radiation or other sterilisation methods.
  • Do not re-use biological indicators; each unit is single use.
  • Do not release the steriliser load until the result of the biological indicator is negative (i.e., no colour change indicating viable spores).
  • Store in a dark place at temperatures between 10-30 °C and relative humidity 30-80 %. Do not freeze. Do not store near sterilising agents or other chemicals.
  • After incubation, dispose of used indicators according to medical/sterile waste regulations.
  • Ensure you use a positive control indicator (non-sterilised) for each incubator batch to validate incubator performance and the viability of the spores.

PACKING TYPES

  • Typical pack size: Box of 100 vials (units) for monitoring.
  • Each vial individually marked with lot number, expiration date, and process indication.

PRODUCT CODE

  • Product Code: BT91 (for standard self-contained biological indicator for H₂O₂).

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