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Bionova Ultra Rapid Self-Contained Biological Indicator for Steam sterilization processes with completed results in 20 minutes, 50/box
Biological Indicator Inoculated with viable Geobacillus stearothermophilus bacterial spores.
FDA, Rapid Fluorescence
Product code: BI-BS-20
Mfr: BT224
Features
- 20-minute readout time, providing swift feedback on the effectiveness of the steam sterilization process.
- Geobacillus Stearothermophilus (ATCC® 7953) spores with a concentration of 10^6 spores per vial.
- Optional Visual pH Confirmation:
- Users have the option to perform a visual pH color change confirmation after 48 hours, enhancing flexibility and offering an additional layer of confirmation.
- Cultural Medium Color Indication:
- The culture medium undergoes a color change, initially to green and then yellow, if the sterilization process is unsuccessful.
- Conversely, a successful process maintains the medium in a purple hue, enabling clear differentiation.
- Dual D-Value Information:
- The product provides D-values for two temperatures (121 ºC and informed values at 132ºC and 135ºC), ensuring comprehensive data for different sterilization conditions.
- Fluorescence Detection Capability:
- The inclusion of fluorescence detection allows for an alternative and rapid assessment of sterilization effectiveness, adding an extra layer of reliability.
- Humidity Consideration for 7-Day Readout:
- When opting for the 7-day readout, users are advised to create a humidified environment to prevent the medium from drying out, ensuring accurate and reliable results.
- Shelf Life:
- 2 year expiration date from the date of manufacture under recommended storage conditions.
- User-Friendly Instructions:
- The product comes with clear and concise instructions for use, including labeling requirements, packaging guidelines, and post-sterilization procedures.
Sold Separately:
Bionova Incubator
Bionova MiniBio Auto-Reader Incubator
- 50 Biological Indicators per box
Storage Guidelines - Store in a dark place within the temperature range of 10-30 °C and 30-80% relative humidity.
- Avoid freezing and keep biological indicators away from sterilizing agents or other chemical products.
Instructions for Use:
Labeling SCBI - Identify SCBI with sterilizer number, load number, and processing date.
Packaging and Placement - Pack SCBI with materials for sterilization, placing it in less exposed areas.
Sterilization Process - Carry out standard sterilization procedures.
Post-Sterilization Steps - After sterilization, open the door, wait five minutes, and carefully remove SCBI.
- Caution: Wear safety glasses and gloves.
- Warning: Avoid excessive handling to prevent glass ampoule bursting. Let SCBI cool to room temperature.
Process Indicator Check - Inspect the Process Indicator on SCBI label. Brown color indicates exposure to steam.
- Note: Color change does not confirm sterility; further checks needed if no change.
Ampoule Crushing and Incubation - Seal the tube's lid and crush the ampoule using an ampoule crusher.
- Shake the tube to soak the spore carrier completely.
- Place SCBI in the incubator.
- Important: Use a non-sterilized SCBI as a positive control daily. Ensure both controls are from the same batch.
Incubation and Readout - Incubate processed and positive control indicators for a maximum of 20 minutes at (60 ± 2) °C.
- Note: Incubation should not exceed a 7-day period after sterilization.
- Failure in sterilization is indicated by fluorescence detection.
- Negative result if no fluorescence at 20 minutes.
- Positive control must show positive fluorescence readout.
- Record positive results and discard SCBI promptly as instructed.
Precautions:WARNING: Do not use SCBI to control sterilization processes other than those specified. WARNING: Place one or more SCBI in hard-to-reach areas to ensure complete chamber sterilization. Evaluate load configurations to identify and place SCBI in all such locations. WARNING: Do not reuse SCBI. WARNING: Do not reuse the sterilizer until the SCBI test result is negative.
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