Self-Contained Biological Indicators (SCBIs) for monitoring moist heat sterilization.

A plastic pipe and cap

A crushable media ampule which contains modified culture medium with a pH indicator. The modified culture medium will transition from the initial Purple color to Yellow in the presence of bacterial growth.

An inoculated carrier of Geobacillus stearothermophilus ATCC 7953 with a population level of ≥10⁵.

The SCBIs is utilized to monitor Moist heat sterilization processes efficacy at 121°C to 134°C.

Monitoring Frequency

For greatest control of sterilized goods it is recommended that one or more SCBIs be included with every load.

Exposure: SCBI’s may be placed inside representative materials or within the chamber directly. Package or wrap product as usual, if applicable. Locate product or SCBIs in most difficult location to sterilize, as outlined in your specific sterilization validation protocol or according to standard operating procedure. Run the cycle.

After sterilization or exposure, remove SCBIs or product from sterilizer and cool SCBIs naturally for ten minutes.

Activation: Squeeze the sides of the unit until an audible click is heard and the glass media ampule contained within is crushed. Ensure that the carrier is immersed in the growth medium. Activate one SCBI which has not been exposed in a sterilization process as a Positive Control.

Incubation: Place the processed, activated SCBI and the Positive Control in a vertical position in an incubator at 56°C to 60°C for a minimum of 48 hours

Monitoring: Examine the SCBIs and record observations.

Control SCBI: The Positive Control SCBI should exhibit a color change to Yellow. If the Positive Control as does not show signs of growth, consider the test invalid.

Test SCBI: A passing sterilization cycle is indicated by Purple color remaining and not transitioning to Yellow. A failed sterilization cycle is indicated by a color change to Yellow.

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

ISO 11138-3:2017 Sterilization of healthcare products – Biological indicators – Part 3 Biological indicators for moist heat sterilization processes.

4℃ to 25℃, 30% to 70% Relative Humidity

Keep away from sunlight, Keep Dry, Protect from sterilizing agent and radioactive sources.

Shelf life: 24 months from the date of manufacture.

Short excursions outside the range of temperature and relative humidity recommended will not impact the performance of the SCBIs.

Do not use damaged SCBIs.

Do not use after the expiration date. Do not refrigerate.

The SCBIs contain live cultures and should be handled with care.

Autoclave for not less than 30 minutes at 121°C or per other validated disposal cycle prior to discard.