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Instant Readout Biological Indicator for Steam - Photon

More info about this product

Additional information
Brand

Bionova

Process

Steam

Packaging

50

Microorganism

Geobacillus stearothermophilus (ATCC 7953)

Population

10^6 Spores/carrier

Read-Out Time

Instant

Regulations

IRAM 37102-1:1999, IRAM 37102-3:1999, ISO 11138-1:2017, ISO 11138-3:2017, ISO 13485:2016., ISO13485:2016/NS-EN

Description

Photon our Instant Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^6 spores per vial. Readout: instant.

Indications for Use United States
Photon, Terragene® Bionova® SCBI (BT225) is an Instant Readout Self-Contained Biological Indicator inoculated with viable 106 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene® Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.

• Gravity-displacement Steam Sterilization Cycles
132 °C, 25 minutes
132 °C, 15 minutes
132 °C, 10 minutes
135 °C, 10 minutes

• Dynamic-air-removal Steam Sterilization Cycles
132 °C, 4 minutes
135 °C, 3 minutes

Outside the United States

Bionova® BT225 Fluorescence Instant Readout Biological Indicators have been designed for quick and easy monitoring of vacuum assisted and gravity displacement steam sterilization cycles at 132-135 °C.

Device Description

Bionova® BT225 Instant Readout Biological Indicators (Photon) 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 stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Steam. Each BT225 has a Process Indicator on label that changes from pink to brown when exposed to Steam.

Precautions

WARNING: Do not use Bionova® BT225 SCBIs to control Hydrogen Peroxide, EO, Dry Heat, Formaldehyde or other sterilization processes. Do not reuse SCBIs.

WARNING: Place one or more SCBIs 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.

Instructions for Use

1. Identify the Bionova® BT225 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 Bionova® BT225 SCBI from the sterilized package. WARNING: 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.

5. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBI has been exposed to Steam. IMPORTANT: this color change does not evidence the process effectiveness to achieve sterility. If the Process Indicator color 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 Bionova® auto-reader 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. 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; capability of 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 the auto-reader incubator. Both, the positive control indicator and the processed indicator, should belong to the same batch.

7. Incubate the processed biological indicator and the positive control indicator in the appropriate Bionova® auto-reader incubator for 7 seconds at (60 ± 2) °C for instant readout. NOTE: Holding time between sterilization and incubation should not exceed a 7-day period. The fluorescence intensity detected by the auto-reader (excitation 340-380 nm / emission 455-465 nm) after 7 seconds of incubation determines the efficiency of the sterilization process. It is good practice to incubate a positive control for a visual color change. Record the positive results and discard the SCBIs immediately, as it is indicated below.

Instant readout: 7 seconds

The instant readout must be carried out in the appropriate Bionova® auto-reader incubators. Fluorescence is emitted after the reader stimulates the indicator with UV light.

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 instant fluorescence results, conventional incubation of Bionova® BT225 SCBI to show a medium color change does not represent an additional advantage.

Visual confirmation: 48 hours

Optionally, you can perform a visual color-change confirmation after a 48-hour incubation. If the sterilization process has not been successful, culture medium will turn yellow during incubation at 60 °C, indicating the presence of living spores. If sterilization was successful, culture medium will remain purple after incubation. A definitive negative result is obtained after 48-hour incubation. The positive control must show a color change from purple to yellow for results to be valid.

Readout time: 7 days

A 7-day readout is optional and may be routinely performed. This is an initial validation of the 7-second instant readout. Fluorescence results are compared to the 7-day visual readouts. NOTE: If 7-day readout is performed, a humidified environment will be required to prevent medium from drying out.

Monitoring frequency

Follow the policies and procedures with the monitoring frequency specified by the professional associations and/or standards corresponding to your country. As recommended practice, and to provide optimal patient safety, Terragene® recommends that each sterilization load be monitored with the appropriate biological indicator.

Storage

Store in a dark place at temperature between 10-30 °C 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 18 months 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 18 months when used as part of SCBI.

End Point Stability Reaction: chemical indicator endpoint shall remain unchanged for a period of not less than 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 °C for 30 minutes, 132 °C for 15 minutes or 134 °C for 10 minutes; or in a dynamic air removal steam sterilizer at132 °C for 4 minutes or 135 °C for 3 minutes.

Description

Photon our Instant Self-contained Biological Indicator for Steam sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^6 spores per vial. Readout: instant.

Indications for Use United States
Photon, Terragene® Bionova® SCBI (BT225) is an Instant Readout Self-Contained Biological Indicator inoculated with viable 106 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene® Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.

• Gravity-displacement Steam Sterilization Cycles
132 °C, 25 minutes
132 °C, 15 minutes
132 °C, 10 minutes
135 °C, 10 minutes

• Dynamic-air-removal Steam Sterilization Cycles
132 °C, 4 minutes
135 °C, 3 minutes

Outside the United States

Bionova® BT225 Fluorescence Instant Readout Biological Indicators have been designed for quick and easy monitoring of vacuum assisted and gravity displacement steam sterilization cycles at 132-135 °C.

Device Description

Bionova® BT225 Instant Readout Biological Indicators (Photon) 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 stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Steam. Each BT225 has a Process Indicator on label that changes from pink to brown when exposed to Steam.

Precautions

WARNING: Do not use Bionova® BT225 SCBIs to control Hydrogen Peroxide, EO, Dry Heat, Formaldehyde or other sterilization processes. Do not reuse SCBIs.

WARNING: Place one or more SCBIs 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.

Instructions for Use

1. Identify the Bionova® BT225 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 Bionova® BT225 SCBI from the sterilized package. WARNING: 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.

5. Check the Process Indicator on SCBI label. A color change to brown indicates that the SCBI has been exposed to Steam. IMPORTANT: this color change does not evidence the process effectiveness to achieve sterility. If the Process Indicator color 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 Bionova® auto-reader 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. 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; capability of 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 the auto-reader incubator. Both, the positive control indicator and the processed indicator, should belong to the same batch.

7. Incubate the processed biological indicator and the positive control indicator in the appropriate Bionova® auto-reader incubator for 7 seconds at (60 ± 2) °C for instant readout. NOTE: Holding time between sterilization and incubation should not exceed a 7-day period. The fluorescence intensity detected by the auto-reader (excitation 340-380 nm / emission 455-465 nm) after 7 seconds of incubation determines the efficiency of the sterilization process. It is good practice to incubate a positive control for a visual color change. Record the positive results and discard the SCBIs immediately, as it is indicated below.

Instant readout: 7 seconds

The instant readout must be carried out in the appropriate Bionova® auto-reader incubators. Fluorescence is emitted after the reader stimulates the indicator with UV light.

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 instant fluorescence results, conventional incubation of Bionova® BT225 SCBI to show a medium color change does not represent an additional advantage.

Visual confirmation: 48 hours

Optionally, you can perform a visual color-change confirmation after a 48-hour incubation. If the sterilization process has not been successful, culture medium will turn yellow during incubation at 60 °C, indicating the presence of living spores. If sterilization was successful, culture medium will remain purple after incubation. A definitive negative result is obtained after 48-hour incubation. The positive control must show a color change from purple to yellow for results to be valid.

Readout time: 7 days

A 7-day readout is optional and may be routinely performed. This is an initial validation of the 7-second instant readout. Fluorescence results are compared to the 7-day visual readouts. NOTE: If 7-day readout is performed, a humidified environment will be required to prevent medium from drying out.

Monitoring frequency

Follow the policies and procedures with the monitoring frequency specified by the professional associations and/or standards corresponding to your country. As recommended practice, and to provide optimal patient safety, Terragene® recommends that each sterilization load be monitored with the appropriate biological indicator.

Storage

Store in a dark place at temperature between 10-30 °C 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 18 months 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 18 months when used as part of SCBI.

End Point Stability Reaction: chemical indicator endpoint shall remain unchanged for a period of not less than 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 °C for 30 minutes, 132 °C for 15 minutes or 134 °C for 10 minutes; or in a dynamic air removal steam sterilizer at132 °C for 4 minutes or 135 °C for 3 minutes.

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