Ultra Rapid Self-Contained Biological Indicator for Steam, 20 Min Results, 50/box

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.

Specs:

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