fbpx Skip to content

Spore strips for EtO and Dry Heat (10^5 spores)

SKU: BT40/5 Category: Tag:
Brand

Bionova

Process

Dry Heat, Ethylene Oxide

Packaging

100

Microorganism

Bacillus Atrophaeus (ATCC 9372)

Population

10^5

Read-Out Time

48 h

Conditions

See Product Description

Regulations

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

Diameter

6 x 25 mm

Description

BT40/5 / Spore Strips Biological Indicator for Ethylene Oxide and Dry Heat sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^5 spores per strip.

The envelope containing Bionova® BT40 Spore Strip is specifically designed for the monitoring of Ethylene Oxide (EO) sterilization processes or for Dry Heat sterilization processes.

Spore strips should be incubated in Bionova® MC1030-2, Bionova® MC1020-2 Growth Medium tube or in appropriate growth medium for Bacillus atrophaeus ATCC 9372 growth. If the sterilization process was not successful, Bionova® MC1030-2 or Bionova® MC1020-2 growth medium will turn to yellow after incubation at 37±2 ºC, thus indicating the existence of living Bacillus atrophaeus spores on the strip.

If the sterilization process was successful, MC1030-2 or MC1020-2 Indicating Medium will remain its original color. A final readout should therefore be performed after 48 hours of growth medium incubation at 37±2 ºC.

Instructions for use

1. Identify Bionova® BT40 envelope by writing on its back the sterilizer number (in case of having more than one), load number and processing date.

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

3. Sterilize as usual.

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

A. Remove the Bionova® BT40 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 in MC1030-2, MC1020-2 culture medium or any other appropriate growth medium 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 MC1030-2, 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® BT40 envelope.

IMPORTANT: Use a non-sterilized spore strip as a positive control at least once per day, when a sterilization cycle is run. Both, processed spore strip and the strip used as positive control must belong to the same batch. 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 during a maximum of 48 hours at 37±2 ºC. It is advisable to make observations every 10 hours. Color change of MC1030-2 or MC1020-2 Growth medium to yellow means a failure on sterilization process.

If after 48 hours no colour change is visible on MC1030-2 or MC1020-2 Growth Medium, the result is negative (i.e. the sterilization process was successful). MC1030-2 or MC1020-2 Indicating Medium used for incubating the spores strips which have not been sterilized (positive control) should turn to yellow in order for the results to be valid.

Description

BT40/5 / Spore Strips Biological Indicator for Ethylene Oxide and Dry Heat sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^5 spores per strip.

The envelope containing Bionova® BT40 Spore Strip is specifically designed for the monitoring of Ethylene Oxide (EO) sterilization processes or for Dry Heat sterilization processes.

Spore strips should be incubated in Bionova® MC1030-2, Bionova® MC1020-2 Growth Medium tube or in appropriate growth medium for Bacillus atrophaeus ATCC 9372 growth. If the sterilization process was not successful, Bionova® MC1030-2 or Bionova® MC1020-2 growth medium will turn to yellow after incubation at 37±2 ºC, thus indicating the existence of living Bacillus atrophaeus spores on the strip.

If the sterilization process was successful, MC1030-2 or MC1020-2 Indicating Medium will remain its original color. A final readout should therefore be performed after 48 hours of growth medium incubation at 37±2 ºC.

Instructions for use

1. Identify Bionova® BT40 envelope by writing on its back the sterilizer number (in case of having more than one), load number and processing date.

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

3. Sterilize as usual.

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

A. Remove the Bionova® BT40 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 in MC1030-2, MC1020-2 culture medium or any other appropriate growth medium 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 MC1030-2, 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® BT40 envelope.

IMPORTANT: Use a non-sterilized spore strip as a positive control at least once per day, when a sterilization cycle is run. Both, processed spore strip and the strip used as positive control must belong to the same batch. 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 during a maximum of 48 hours at 37±2 ºC. It is advisable to make observations every 10 hours. Color change of MC1030-2 or MC1020-2 Growth medium to yellow means a failure on sterilization process.

If after 48 hours no colour change is visible on MC1030-2 or MC1020-2 Growth Medium, the result is negative (i.e. the sterilization process was successful). MC1030-2 or MC1020-2 Indicating Medium used for incubating the spores strips which have not been sterilized (positive control) should turn to yellow in order for the results to be valid.

FAQs

You can get commercial assistance contacting us here

You can find product resources and information, visiting our download center here or on our products page.

Our products can be obtained by talking with our commercial executives, that will guide through all your buying processes, giving our best effort for an easy and comforting purchasing experience. You can contact our team here.

To be a Terragene distributor, you can get in touch with our commercial executives filling our contact formulary here.