Steam Biological Indicator

TECHNICAL DATA SHEET

STEAM BIOLOGICAL INDICATOR

PRODUCT CODE: 4ASBI

RELATED STANDARDS: 4A Medical Steam Biological Indicator is under the scope of ISO 11138 standard.

INTENDED USE: Biological Indicator is specifically designed for the monitoring vacuum assisted steam sterilization processes at 121-134°C and gravity displacement steam sterilization cycles at 121-134°C. Use a non-sterilized biological indicator as positive control whenever a processed biological indicator is incubated. The positive control ensures that appropriate incubation conditions were met. Incubate the processed biological indicator and the indicator used as positive control for a maximum of 24 hours at 60+/-2°C. Regarding should be made at convenient intervals of 10 hours.  

Color change of the growth indicator medium from purple to yellow means that a sterilization process failure has occurred. If at 24 hours there is no color change in the processed indicators, a final negative result is made (the sterilization process was acceptable). The positive control indicator should show a yellow color change for the results to be valid.  

OPERATION CONDITIONS: If sterilization process was not successful, the indicator medium will change from purple to yellow after incubation at 60+/-2°C, thus indicating the presence of live Geobacillus stearothermophilus spores.

If the sterilization process was successful, indicator medium will remain purple after incubation. The final readout should be made at 24 hours of incubation at 60+/-2°C.

COMPOSITION: Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores soaked on a carrier. It also has a growth indicator medium of purple color contained within the glass ampule.

STORAGE AND DISPOSAL: Store it in a dark place at temperatures between 10-30°C, 30-80% relative humidity. Do not freeze. Do not store these biological indicators near sterilizing agents or other chemical products. Each box contains 100 pieces indicator.   

PACKAGING: 100 pcs in box.