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Spore suspension for EtO (10^6 spores /0,1ml)

SKU: BT10S/7 Category: Tag:
Brand

Bionova

Process

Ethylene Oxide

Packaging

1 x 10ml

Microorganism

Bacillus Atrophaeus (ATCC 9372)

Population

10^6

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

Volume

10 ml

Description

BT10S/7 / Spore Suspension for direct inoculation of products or preparation of customized biological indicators for monitoring Ethylene Oxide and Dry Heat sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores /0,1ml.

Bionova® BT10S Spore Suspension is designed for direct inoculation of products or for the preparation of customized Biological Indicators used for control of Ethylene Oxide sterilization processes and/or Dry Heat sterilization processes.

Directions for use

1. Perform inoculation operations in a clean area.

2. Samples to be inoculated should be representative of product being sterilized.

3. Select the spore suspension of appropriate population for the sterilization method use. For most purposes, inoculation of products with approximately one million 10^6 spores provides a suitable challenge.

NOTE: Spore suspensions are standardized on the basis of number of spores per 0.1 ml of suspension.

4. Shake vial vigorously before each use.

5. Use a sterile pipette or syringe to accurately deliver the volume of suspension to be utilized.

6. Deposit suspension onto product. The area to be inoculate should be the most difficult for the sterilizing agent to penetrate.

7. Allow product to dry at 20-30 ºC for approximately 24 hours.

8. Package inoculated product exactly like product being sterilized and identify as €œInoculated Test Sample.

9. Distribute €œInoculated Test Sample throughout the sterilizer load.

10. After sterilization cycle is complete, test the inoculated products as soon as possible using an appropriate culture medium, and incubate at 37 ºC. We suggest the use of Bionova® MC1020 or MC1030 culture media for a final result at 48 hours of incubation. For a conventional culture medium such as TSB, incubate at the optimal temperature for up to 7 days.

IMPORTANT: Each time that a processed product is incubated use an unprocessed product as a positive control. The positive control ensures that the incubation conditions were met. An uninoculated product can be used as a negative control.

A color change to yellow of the incubation medium shows a failure in the sterilization process. If after 48 hours of incubation, the purple color of the medium remains the same, the result is negative (the sterilization process was efficient). The positive control must change to yellow in order to validate the results.

The positive vials have to be registered and then have to be processed as indicated below.

WARNING: Do not use the sterilizer until the biological indicator shows a negative result. (The processed indicator remains purple after 48 hours of incubation).

Description

BT10S/7 / Spore Suspension for direct inoculation of products or preparation of customized biological indicators for monitoring Ethylene Oxide and Dry Heat sterilization processes. Bacillus atrophaeus (ATCC 9372) 10^6 spores /0,1ml.

Bionova® BT10S Spore Suspension is designed for direct inoculation of products or for the preparation of customized Biological Indicators used for control of Ethylene Oxide sterilization processes and/or Dry Heat sterilization processes.

Directions for use

1. Perform inoculation operations in a clean area.

2. Samples to be inoculated should be representative of product being sterilized.

3. Select the spore suspension of appropriate population for the sterilization method use. For most purposes, inoculation of products with approximately one million 10^6 spores provides a suitable challenge.

NOTE: Spore suspensions are standardized on the basis of number of spores per 0.1 ml of suspension.

4. Shake vial vigorously before each use.

5. Use a sterile pipette or syringe to accurately deliver the volume of suspension to be utilized.

6. Deposit suspension onto product. The area to be inoculate should be the most difficult for the sterilizing agent to penetrate.

7. Allow product to dry at 20-30 ºC for approximately 24 hours.

8. Package inoculated product exactly like product being sterilized and identify as €œInoculated Test Sample.

9. Distribute €œInoculated Test Sample throughout the sterilizer load.

10. After sterilization cycle is complete, test the inoculated products as soon as possible using an appropriate culture medium, and incubate at 37 ºC. We suggest the use of Bionova® MC1020 or MC1030 culture media for a final result at 48 hours of incubation. For a conventional culture medium such as TSB, incubate at the optimal temperature for up to 7 days.

IMPORTANT: Each time that a processed product is incubated use an unprocessed product as a positive control. The positive control ensures that the incubation conditions were met. An uninoculated product can be used as a negative control.

A color change to yellow of the incubation medium shows a failure in the sterilization process. If after 48 hours of incubation, the purple color of the medium remains the same, the result is negative (the sterilization process was efficient). The positive control must change to yellow in order to validate the results.

The positive vials have to be registered and then have to be processed as indicated below.

WARNING: Do not use the sterilizer until the biological indicator shows a negative result. (The processed indicator remains purple after 48 hours of incubation).

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