Biological Indicator for EO (14-22110)
Self-Contained Biological Indicators (SCBIs)
Conforms to ISO 11138
Roshan Rai Sepahan designs and validates all BIs according to ISO 11138 specifications.
Self-Contained Biological Indicators (SCBIs) are for use in monitoring ethylene oxide (EO) sterilization processes. Each SCBI is completely self contained within a vial and contains a disc inoculated with a species bacterial spores Bacillus atrophaeus (ATCC 9372) and an ampoule of specially formulated soybean casein digest growth medium with a pH indicator. The vial label contains a process indicator for EO.
The color change of biological indicator to yellow, indicates a defect in the sterilization process after the mentioned period of time. If there is no color change in the indicator after the specified period of time, the result of the test will be negative and this indicates that sterilization performance is perfect. Positive control should have a color changes from green to yellow for the ethylene oxide that indicates validation of the incubation process.
Features:
- 10^6 Spore Bacillus Atrophaeus (BA)
- Incubate the Vial at 37+2 °C for 48 hrs
Warning :
Avoid reuse of biological indicators.
Do not break the indicator immediately after leaving and do not force a lot to move it , because it can cause outpour of the fluid from the SCBIs.
Maintenance of biological indicator :
Keep in a dark place at temperature of 10-30 ° C and a relative humidity of 80% -30%.
Do not put in a freezer.
Do not put these indicators near disinfectants and other chemical products.
Disposal instruction
Dispose the biological indicators after use, in accordance with your country's health and safety laws You can put the positive biological indicators in an autoclave at 121°C for at least 20 minutes or put at steam sterilizer under vacuum at 134°C for 10 minutes
