Fluorescence SCBI For EO, 37°C (4 hour), 50/Bx

Description

Rapid Self-contained Biological Indicator for Ethylene Oxide sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores per vial. Readout: 4 hours.

An optional visual pH color change confirmation could be made after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to a greenish color first, and then to yellow during incubation at 37 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain blue after the incubation process.

7-day readout for visual confirmation by color change is optional and not intended to be routinely performed; it is an initial validation of the 4 hour-reading. Fluorescence results may be compared to the 7-day visual reading.

Instructions For Use:

  1. Identify the Terragene® Bionova® BT110 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label.
  2. Pack the SCBI 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 SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT110 SCBI from the sterilized package.
  5. Check the Process Indicator on SCBI label. A color change to green indicates that the SCBI has been exposed to Ethylene Oxide. 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 SCBI 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 SCBI in the incubator.
  7. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader incubators for a maximum of 4 hours at (37 ± 2) °C for rapid readout.

Note: Holding time between sterilization and incubation should not exceed a 7-day period. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means failure in the sterilization process. If no fluorescence is detected after 4 hours of incubation, the result is negative.

The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for visual color change. If chamber relative humidity is unknown or < 35 %, continue to incubate the Biological Indicator for a pH color change result, since low relative humidity may increase the fluorescent readout time beyond 4 hours.

Specifications:

  • Process: Ethylene Oxide
  • Microorganism: Bacillus atrophaeus (ATCC 9372)
  • Population: 10^6 Spores/carrier
  • Read-Out Time: 4 h
  • Regulations: IRAM 37102-1, IRAM 37102-2, ISO 11138-1, ISO 11138-2
  • Length: 40 mm
Product form

Rapid Self-contained Biological Indicator for Ethylene Oxide sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores per vial. Readout: 4 hours.... Read more

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SKU: BT110

$250.99 $210.99 Excl. VAT

  • Shipped today? Order within: Apr 29, 2024 17:00:00 -0400
Shipping information

Order processing time:

1-2 business days for order to process and shipped.

Delivery carriers:

UPS, FedEx and USPS. Tracking details will be provided to the customer via email.

Returns:


SurgiMac brand Products returns - If you are unsatisfied with your SurgiMac order, we offer a no risk return policy. Within 30 days of receipt, you may return your new and unused product in its resalable condition for a full refund minus the cost of the shipping label. A restocking fee may apply. For customized items, a refund may be issued if there was an error on our end. Unfortunately, all sales of infection control products are final and not eligible for a refund. Other brands - Brands other than SurgiMac, we will provide credit after we receive credit from the manufacturer. Our representative will serve as your advocate to resolve any issues quickly and fairly. If the manufacturer agrees that the product needs to be returned or replaced, we will provide the necessary installation services at no extra cost. Any manufacturer’s restocking fee will be your responsibility. Instructions: Inspect your order as soon as it arrives. To arrange a return, have your order number ready and reach out to us via live chat or email (info@surgimac.com). We'll get back to you within one business day with the next steps for obtaining a return authorization.

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Description

Rapid Self-contained Biological Indicator for Ethylene Oxide sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores per vial. Readout: 4 hours.

An optional visual pH color change confirmation could be made after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to a greenish color first, and then to yellow during incubation at 37 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain blue after the incubation process.

7-day readout for visual confirmation by color change is optional and not intended to be routinely performed; it is an initial validation of the 4 hour-reading. Fluorescence results may be compared to the 7-day visual reading.

Instructions For Use:

  1. Identify the Terragene® Bionova® BT110 SCBI by writing the sterilizer number (in case of having more than one), load number and processing date on the label.
  2. Pack the SCBI 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 SCBI from the package. CAUTION: Wear safety glasses and gloves when removing the Terragene® Bionova® BT110 SCBI from the sterilized package.
  5. Check the Process Indicator on SCBI label. A color change to green indicates that the SCBI has been exposed to Ethylene Oxide. 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 SCBI 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 SCBI in the incubator.
  7. Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® Auto-Reader incubators for a maximum of 4 hours at (37 ± 2) °C for rapid readout.

Note: Holding time between sterilization and incubation should not exceed a 7-day period. Fluorescence detection by the reader (excitation 340-380 nm / emission 455-465 nm) means failure in the sterilization process. If no fluorescence is detected after 4 hours of incubation, the result is negative.

The positive control must give positive fluorescence readout. It is good practice to incubate a positive control for visual color change. If chamber relative humidity is unknown or < 35 %, continue to incubate the Biological Indicator for a pH color change result, since low relative humidity may increase the fluorescent readout time beyond 4 hours.

Specifications:

  • Process: Ethylene Oxide
  • Microorganism: Bacillus atrophaeus (ATCC 9372)
  • Population: 10^6 Spores/carrier
  • Read-Out Time: 4 h
  • Regulations: IRAM 37102-1, IRAM 37102-2, ISO 11138-1, ISO 11138-2
  • Length: 40 mm

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