Rapid Read, H2O2 Biological Indicators for Hydrogen Peroxide Sterilization, 2h Results, 50/box
BT95
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$281.00
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This product has been discontinued
This item has been replaced by the BI-BH202-30 Biological Indicator, featuring an improved 30-minute readout and compatibility with MiniBio incubators.
View the New BT96 → Super Rapid Read, H2O2 Biological Indicators, 30-Min Results, 50/box
.Bionova Rapid Self-contained H2O2 Biological Indicator for Plasma or Vaporized Hydrogen Peroxide sterilization processes, with completed results in 2 Hour, 50/box.
2h Biological Indicator for Hydrogen Peroxide (FDA)
Rapid Fluorescence
Product code: BI-BH202-2
Mfr: BT95
An optional visual pH color change confirmation could be performed after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to yellow during incubation at 60 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain purple after the incubation process.
Features:
- A single-use Self-Contained Biological Indicator (SCBI)
- Geobacillus stearothermophilus (ATCC® 7953) spores with a concentration of 10^6 spores per vial.
- Features a Process Indicator on the label that changes color (purple to green) upon exposure to Hydrogen Peroxide, confirming sterilization.
- Clear instructions for identification, packing, and sterilization process, emphasizing safety during SCBI removal.
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Quality Control Measures:
- Recommends using a non-sterilized SCBI as a positive control to ensure correct incubation conditions and spore viability.
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Ampoule Crushing and Incubation:
- Instructs on proper handling, including ampoule crushing, tube shaking, and placement in Bionova Auto-Reader Incubators for rapid readout.
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Rapid Readout and Fluorescence Detection:
- Provides a maximum incubation time of 2 hours at (60 ± 2) °C for quick results.
- Fluorescence detection (excitation 340-380 nm / emission 455-465 nm) in the incubator signifies successful sterilization.
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Storage and Shelf Life:
- Store in a dark place at 10-30 °C, 30-80% relative humidity.
- Shelf life of 2 years from the manufacture date. Endpoint Stability Reaction ensures chemical indicator stability for at least 6 months.
Sold Separately: Bionova MiniBio Auto-Reader Incubator
- Rapid Readout:
- Achieves a rapid readout in just 2 hours at 60 °C, providing quick and efficient results.
- Fluorescence Detection:
- Excitation 340-380 nm / emission 455-465 nm. Lack of fluorescence after 30 minutes indicates sterilization success; positive fluorescence means sterilization failure.
- Positive Control:
- A positive control must yield positive fluorescence readout, and it is recommended to incubate it for visual color change.
- Visual Confirmation (Optional):
- After 48 hours, a visual pH color change can be performed. Yellow indicates sterilization failure, while purple confirms success.
- Incubation Conditions:
- If the 7-day readout is performed, a humidified environment is necessary to prevent medium drying out. The holding time between sterilization and incubation should not exceed 7 days.
Important Note: Holding time between sterilization and incubation should not exceed a 7-day period. Fluorescence detection indicates sterilization failure, and a positive control is crucial for validation.
Instructions for Use:
1. Identify the Biological Indicators by writing the sterilizer number (in case of having more than one), load number and processing date on the label.
2. Pack the Biological Indicator along with materials to be sterilized in an appropriate package according to recommended sterilization practices. Place the package in those areas which are considered most inaccessible for the sterilizing agent
(e.g., the center of the load and areas near the door).
3. Sterilize as usual.
4. After the sterilization process has finished, open the sterilizer door, wait five minutes and remove the Biological Indicators from the package.
CAUTION: Wear safety glasses and gloves when removing the Biological Indicator from the sterilized package.
WARNING: Do not crush or handle the Biological Indicator excessively, since this might cause the glass ampoule to burst. Let the Biological Indicator cool down until it reaches room temperature.
5. Check the Process Indicator on Biological Indicator label. A color change to green indicates that the Biological Indicator has been exposed to Hydrogen Peroxide.
IMPORTANT: This color change does not evidence the process effectiveness to achieve sterility. If the color of the Process Indicator has not changed, check the sterilization process.
6. Press the lid to seal the tube. Crush the ampoule contained in the Biological Indicator with an individual ampoule crusher or with the ampoule crusher placed within the incubator´s incubation area. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spore carrier entirely. Finally, place the Biological Indicator in the incubator.
IMPORTANT: Use a non-sterilized Biological Indicator as a positive control at least once per day, when a sterilization cycle is run. The positive control ensures that correct incubation conditions were met; the capability of the medium to promote rapid growth; viability of spores has not been altered due to improper storage temperature, humidity or proximity to chemicals and proper functioning of Terragene® Bionova® Auto-Reader Incubators. Both, the positive control indicator and the processed indicator, should belong to the same batch.
7. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader incubators for a maximum of 30 minutes at (60 ± 2) °C for super rapid readout.
Precautions WARNING:
Do not use Biological Indicator to control EO, Dry Heat, Formaldehyde or other sterilization processes different from the specified.
Do not reuse Biological Indicator
WARNING:
Place one or more Biological Indicator in sterilizing hard-to-reach areas to ensure all areas of the chamber are sterilized.
Please evaluate all load configurations to ensure ALL hard-to-reach areas have been identified, and place a Biological Indicator in each of those locations.
Do not reuse the sterilizer until the Biological Indicator test result is negative.
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Super Rapid Read, H2O2 Biological Indicators for Hydrogen Peroxide Sterilization, 30-Min Results, 50/box
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