Hyper Rapid Self-contained Biological Indicator for Vaporized Hydrogen Peroxide sterilization processes. Final readout: 5 minutes.

Indications For Use:

Terragene® Bionova® BT98 fluorescence hyper rapid readout Biological Indicators have been designed for quick and easy monitoring of Plasma or vaporized hydrogen Peroxide sterilization cycles.

Device Description:

Terragene® Bionova® BT98 fluorescence hyper rapid readout Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier and a glass ampoule with a culture medium, enclosed with a colored cap.

Each tube contains a population of Geobacillus stearotermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT98 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide.

Precautions:

Warning: Do not use Terragene® Bionova® BT98 SCBI to control EO, Dry Heat, Formaldehyde or other sterilization processes different from specified. Do not reuse SCBI.

Warning: Place one or more SCBI 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 SCBI in each of those locations.

Warning: Do not reuse the sterilizer until the SCBI test result is negative.

Instructions For Use:

Identify the Terragene® Bionova® BT98 SCBI by writing the sterilizer number (incase of having more than one), load number and processing date on the label.
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).
Sterilize as usual.
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® BT98 SCBI from the sterilized package. ( Do not crush or handle the SCBI excessively, since this might cause the glass ampoule to burst. Let the SCBI cool down until it reaches room temperature.)
Check the Process Indicator on SCBI label. A color change to green indicates that the SCBI 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.
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.
Incubate the processed indicator and the positive control indicator in the appropriate Terragene® Bionova® auto-reader incubators for a maximum of 5 minutes at (60 ± 2) °C for hyper rapid readout. (Holding time between sterilization and incubation should not exceed a 1-hour period.)

Important: Use a non-sterilized SCBI 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.

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 5 minutes 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. Record positive results and discard the SCBIs immediately, as it is indicated below.

Hyper Rapid Readout: 5 minutes

The hyper rapid readout must be carried out in the appropriate Terragene® Bionova® auto-reader incubators. Fluorescence is emitted after the reader stimulates the spore carrier with UV light. Final readout of negative results is readily available after 5 minutes of incubation.

Fluorescence readout is an indirect measure of the viability of Geobacillus stearothermophilus spores after the sterilization process (positive results). Furthermore, a failure in the sterilization process can also become evident by culture medium color-change. Due to the high sensitivity of the fluorescence results at 5 minutes, conventional incubation for color change of Terragene® Bionova® SCBI BT98 is not an advantage.

Visual Confirmation: 5 days:

Optionally, you can perform a visual color-change confirmation after a 5-day incubation. If the sterilization process has not been successful, culture medium will turn to yellow during incubation at (60 ± 2) ºC, indicating the presence of living spores.

If sterilization was successful, culture medium will remain purple after incubation. The positive control must show a color change from purple to yellow for results to be valid. ( If 5-day readout is performed, a humidified environment will be required to prevent medium from drying out.)

Readout Time: 7 days

A 7-day readout is optional and may be routinely performed. This is an initial validation of the 5-minute readout. Fluorescence results are compared to the 7-day visual readouts.

Monitoring Frequency:

Follow facility policies and procedures which should specify a biological indicator monitoring frequency compliant with professional association recommended practices and/or national guidelines and standards. As the best practice and to provide optimal patient safety, Terragene® recommends that every sterilization load be monitored with an appropriate biological indicator.

Storage:

Store in a dark place at temperature between 10-30 ºC and 30-80 % relative humidity. Do not freeze. Do not store biological indicators near sterilizing agents or other chemical products.

Shelf Life:

Biological Indicators have an expiration date of 2 years from the date of manufacture when stored at recommended conditions. Do not use indicators after their expiration date. Chemical Process Indicator on SCBI label have an expiration date of 2 years when used as part of SCBI. Endpoint Stability Reaction: Chemical Process Indicator endpoint shall remain unchanged for a period of 6 months when stored at previously indicated conditions.

Disposal:

Discard biological indicators after use according to your country’s healthcare and safety regulations. The positive biological indicators can be autoclaved in a gravity air displacement steam sterilizer at 121 ºC for 5 minutes, 132 ºC for 15 minutes or 134 ºC for 10 minutes; or in a dynamic air removal steam sterilizer at 132 °C for 4 minutes or 135 °C for 3 minutes.

Specifications:

Population: 10^6 Spores/carrier
Read-Out Time: 5 min
Regulations: IRAM 37102-1:1999, ISO 11138-1:2017, ISO 13485:2016 / NS-EN ISO 13485:2016

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