Formaldehyde

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 Formaldehyde(FO) sterilization processes. Each SCBI is completely self contained within a vial and contains a disc inoculated with a species bacterial spores Geobacillus stearothermophilus (ATCC 7953)  and an ampoule of specially formulated soybean casein digest growth medium with a pH indicator. The vial label contains a process indicator for FO.

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 violet to yellow for the Formaldehyde that indicates validation of the incubation process.

Features:

• For Saturated Formaldehyde Sterilization
• 10^6 Spore Geobacillus Stearothermophilus (GS)
• Incubate the Vial at 56+2 °C for 24 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 Formaldehyde sterilizer under vacuum at 134°C for 10 minutes