Rapid Self-Contained Biological Indicator for Steam, 3h Results, 50/box

• 3 hour readout time for 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.

Type: Sterilizer

• 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.

1. Labeling SCBI

   • Identify SCBI with sterilizer number, load number, and processing date.

2. Packaging and Placement

   • Pack SCBI with materials for sterilization, placing it in less exposed areas.

3. Sterilization Process

   • Carry out standard sterilization procedures.

4. 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.

5. 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.

6. 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.

7. Incubation and Readout

   • Incubate processed and positive control indicators for a maximum of 3 hour 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 3 hour
   • Positive control must show positive fluorescence readout.
   • Record positive results and discard SCBI promptly as instructed.