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Spore strips for Dry Heat, Steam and EtO

SKU: BT60 Category: Tag:
Brand

Bionova

Process

Dry Heat, Ethylene Oxide, Steam

Packaging

100

Microorganism

Bacillus Atrophaeus (ATCC 9372), Geobacillus Stearothermophilus (ATCC 7953)

Population

10^5, 10^6

Read-Out Time

24 h, 48 h

Conditions

See Product Description

Regulations

IRAM 37102-1, IRAM 37102-2, IRAM 37102-3, ISO 11138-1, ISO 11138-2, ISO 11138-3, ISO 11138-4

Diameter

6 x 25 mm

Description

BT60 / Dual Spore Strips Biological Indicator for Steam, Ethylene Oxide and Dry Heat sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^5 or 10^6 and Bacillus atrophaeus (ATCC 9372) 10^6 spores per strip.

Designed to control Steam (Steam), Ethylene Oxide (EO) and Dry Heat (DRY) sterilization processes. Spore strips should be incubated in an appropriate growth medium for the corresponding Geobacillus stearothermophilus ATCC 7953 or Bacillus atrophaeus ATCC 9372 growth. It is suggested the use of Bionova® MC20-2 Culture Medium for growth of Geobacillus stearothermophilus ATCC 7953 at 60 °C, MC1030-2 for growth of Bacillus atrophaeus ATCC 9372 at 37 °C and/or MC1020-2 for growth of both spores, selective according to the incubation temperature (Geobacillus stearothermophilus 60 °C / Bacillus atrophaeus 37 °C).

If the sterilization process was not successful, MC20-2, MC1030-2 or MC 1020-2 Growth Medium will turn to yellow after incubation at the corresponding temperature, thus indicating the existence of living spores on the strips.

If the sterilization process was successful, MC20-2, MC1030-2 or MC1020-2 Indicating Medium will remain its original color. A final readout should therefore be performed after 24 hours of growth medium incubation at 60±2 °C (MC20-2 and/or MC1020-2) for steam sterilization processes control, or 48 hours at 37±2 °C (MC1030-2 and/or MC1020-2) for Ethylene Oxide and Dry Heat sterilization processes control.

Instructions for use

1. Identify the Bionova® BT60 envelope by writing the sterilizer number (in case of having more than one), load number and processing date on its back.

2. Pack it in an appropriate package along with material to be sterilized, according to recommended sterilization practices. Place the envelope in those areas you consider a priori more inaccessible to the sterilizing agent. A typical problematic area is the center of the load.

3. Sterilize as usual.

4. After the sterilization process has finished, you can:

A. Remove the Bionova® BT60 envelope from the package for processing and incubation.

B. For Ethylene Oxide sterilization, you can aerate the package containing the biological indicator with the rest of the load or remove the biological indicator from the sterilization package for incubation prior to material aeration.

5. Tear up the envelope at one end very carefully under sterility conditions (eg. laminar flow cabinet) and transfer spore strip with a sterile clamp to MC20-2, MC1030-2 or MC1020-2 Growth Medium tube, or to any other appropriate growth medium. IMPORTANT: Use latex gloves and chin strap when transferring spore strips from the envelope to growth medium tube.

WARNING! Avoid spore strip contact with any kind of surface including the outer part of Growth Medium tube and of Bionova® BT60 envelope.

IMPORTANT: Use a spore strip which has not been subjected to the sterilization process as a positive control each time a processed strip is incubated. Positive control guarantees that the incubation was carried out under appropriate conditions.

6. Incubate processed spore strips along with the strip used as positive control at the corresponding temperatures: 60±2 °C or 37±2 °C. It is advisable to make observations every 10 hours.

Color change of MC20-2, MC1030-2 or MC1020-2 Growth Medium to yellow means a failure in the sterilization process. If after incubation, no color change is visible on the growth medium, the result is negative (i.e. the sterilization process was successful). MC20-2, MC1030-2 or MC1020-2 Indicating Medium used for incubating the spore strips which have not been sterilized (positive control) should turn to yellow in order for the results to be valid.

Description

BT60 / Dual Spore Strips Biological Indicator for Steam, Ethylene Oxide and Dry Heat sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^5 or 10^6 and Bacillus atrophaeus (ATCC 9372) 10^6 spores per strip.

Designed to control Steam (Steam), Ethylene Oxide (EO) and Dry Heat (DRY) sterilization processes. Spore strips should be incubated in an appropriate growth medium for the corresponding Geobacillus stearothermophilus ATCC 7953 or Bacillus atrophaeus ATCC 9372 growth. It is suggested the use of Bionova® MC20-2 Culture Medium for growth of Geobacillus stearothermophilus ATCC 7953 at 60 °C, MC1030-2 for growth of Bacillus atrophaeus ATCC 9372 at 37 °C and/or MC1020-2 for growth of both spores, selective according to the incubation temperature (Geobacillus stearothermophilus 60 °C / Bacillus atrophaeus 37 °C).

If the sterilization process was not successful, MC20-2, MC1030-2 or MC 1020-2 Growth Medium will turn to yellow after incubation at the corresponding temperature, thus indicating the existence of living spores on the strips.

If the sterilization process was successful, MC20-2, MC1030-2 or MC1020-2 Indicating Medium will remain its original color. A final readout should therefore be performed after 24 hours of growth medium incubation at 60±2 °C (MC20-2 and/or MC1020-2) for steam sterilization processes control, or 48 hours at 37±2 °C (MC1030-2 and/or MC1020-2) for Ethylene Oxide and Dry Heat sterilization processes control.

Instructions for use

1. Identify the Bionova® BT60 envelope by writing the sterilizer number (in case of having more than one), load number and processing date on its back.

2. Pack it in an appropriate package along with material to be sterilized, according to recommended sterilization practices. Place the envelope in those areas you consider a priori more inaccessible to the sterilizing agent. A typical problematic area is the center of the load.

3. Sterilize as usual.

4. After the sterilization process has finished, you can:

A. Remove the Bionova® BT60 envelope from the package for processing and incubation.

B. For Ethylene Oxide sterilization, you can aerate the package containing the biological indicator with the rest of the load or remove the biological indicator from the sterilization package for incubation prior to material aeration.

5. Tear up the envelope at one end very carefully under sterility conditions (eg. laminar flow cabinet) and transfer spore strip with a sterile clamp to MC20-2, MC1030-2 or MC1020-2 Growth Medium tube, or to any other appropriate growth medium. IMPORTANT: Use latex gloves and chin strap when transferring spore strips from the envelope to growth medium tube.

WARNING! Avoid spore strip contact with any kind of surface including the outer part of Growth Medium tube and of Bionova® BT60 envelope.

IMPORTANT: Use a spore strip which has not been subjected to the sterilization process as a positive control each time a processed strip is incubated. Positive control guarantees that the incubation was carried out under appropriate conditions.

6. Incubate processed spore strips along with the strip used as positive control at the corresponding temperatures: 60±2 °C or 37±2 °C. It is advisable to make observations every 10 hours.

Color change of MC20-2, MC1030-2 or MC1020-2 Growth Medium to yellow means a failure in the sterilization process. If after incubation, no color change is visible on the growth medium, the result is negative (i.e. the sterilization process was successful). MC20-2, MC1030-2 or MC1020-2 Indicating Medium used for incubating the spore strips which have not been sterilized (positive control) should turn to yellow in order for the results to be valid.

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