Self-Contained Biological Indicators (BIs) for EO Sterilization is designed for monitoring EO sterilization processes. It consists of a spore carrier, a recovery medium (sealed in a glass ampoule) and a plastic vial. Each BI contains a spore population ≥1.0×10⁶cfu.The D-Value is ≥2.0 (Test condition: T 54±1 ℃, RH 60±10%, EO concentration 600±30mg/L).

The presence of Bacillus atrophaeus ATCC9372 spores are detected by a visual color change (media turns yellow). The yellow color change indicates a sterilization process failure. The final readout of a negative result (media remains green) is made after 48 hours of incubation.

Identify the BI by writing the sterilizer, load number and processing date on the indicator label. Place the BI in a representative tray configuration as recommended by professional association guidelines of national standards for healthcare facility practice.

Place the representative tray in the most challenging area of the sterilizer. This is typically on the bottom shelf, over the drain, however, the sterilizer manufacturer should be consulted to identify the area of the chamber least favorable to sterilization. Process the load according to recommended practices.

After completion of the cycle, take the representative tray out of the sterilizer, and remove the BI.

To activate the biological indicator, Press the cap of BI down firmly to close the cap and crush the glass ampoule. Visually verify the media has flowed into the growth chamber at the bottom of the vial. If the medica hasn’t filled the growth chamber, hold the BI by the cap and flick it until media fills the growth chamber.

Incubate the activated BI at 33℃- 37℃, with a positive control by use one non-processed BI.

After 48 hours of incubation, readout the results. The appearance of a yellow color in the processed indicator demonstrates bacterial growth and a sterilization process failure. No color change (media remains green) indicates an adequate sterilization process.

The positive control indicator should show a yellow color change for the processed indicator results to be valid.

Confirm the integrity of the product prior to use. The side hole of the cap should not be closed and the BI is returned to room temperature.

Store the BI at a temperature of 4℃ to 25℃ and a relative humidity of 30% to 70%. Keep away from sterilizing agents and avoid sunlight and UV rays. Do not freeze the BI.

Use the BI within the validity period. Product shelf life is two years after production.

Dispose of used Bis according to your health care facility policy.

ISO 11138-1:2017 Sterilization of health care products – Biological indicators – Part 1: General requirements.

ISO 11138-2:2017 Sterilization of healthcare products – Biological indicators – Part 2 Biological indicators for ethylene oxide sterilization processes.