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Spore suspension for Steam, LTSF or VH2O2 (10^1 spores x 0,1ml)

SKU: BT20S/2 Category: Tag:
Brand

Bionova

Process

Formaldehyde, Hydrogen Peroxide, Steam

Packaging

1 x 10ml

Microorganism

Geobacillus Stearothermophilus (ATCC 7953)

Population

10^1

Read-Out Time

24 h, 48 h

Conditions

See Product Description

Regulations

IRAM 37102-1, IRAM 37102-3, ISO 11138-1, ISO 11138-3, ISO 11138-5

Volume

10 ml

Description

BT20S/2 / Spore Suspension for direct inoculation of products or preparation of customized biological indicators for monitoring for Steam, Formaldehydeand Plasma or Vaporized Hydrogen Peroxide sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^1 spores /0,1ml.

Bionova® BT20S Spore Suspension has been designed for direct inoculation of products or for the preparation of customized Biological Indicators used for control of Steam, Formaldehyde, Hydrogen Peroxide and/or Peracetic Acid sterilization processes.

The combined use of inoculated products, pre-sterilization microorganism count determinations (bioburden), and physical process measurements and controls should be employed to validate sterilization processes.

WARNING: Use BT20S biological indicator only for the control of Steam, Formaldehyde, Hydrogen Peroxide and/or Peracetic Acid sterilization processes. Do not use for other processes such as Ethylene Oxide, Dry Heat and/or Radiation sterilization.

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 product 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. Vortex vial before each use.

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

a) If syringe is used, disinfect stopper surface and pull syringe plunger halfway back. Insert needle through stopper, push plunger in, and then slowly withdraw plunger to fill syringe to desired volume.

b) If a pipette is used, remove stopper and insert pipette. Dispense the desired volume.

6. Inoculate the product appropriately. The area to be inoculated should be the most difficult for the sterilizing agent to penetrate.

7. Identify the inoculated samples.

8. Distribute €œInoculated Test Samples throughout the sterilizer load.

9. After sterilization cycle is completed, test the inoculated products as soon as possible using an appropriate culture medium, and incubate at 60 °C. We suggest Bionova® MC20-2 or MC1020-2 media to final reading at 24 hours for Steam/Hydrogen Peroxide sterilization and at 48 hours for Formaldehyde sterilization. For conventional culture medium like TSB, incubation for 7 days at 60 °C is recommended.

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

Description

BT20S/2 / Spore Suspension for direct inoculation of products or preparation of customized biological indicators for monitoring for Steam, Formaldehydeand Plasma or Vaporized Hydrogen Peroxide sterilization processes. Geobacillus stearothermophilus (ATCC 7953) 10^1 spores /0,1ml.

Bionova® BT20S Spore Suspension has been designed for direct inoculation of products or for the preparation of customized Biological Indicators used for control of Steam, Formaldehyde, Hydrogen Peroxide and/or Peracetic Acid sterilization processes.

The combined use of inoculated products, pre-sterilization microorganism count determinations (bioburden), and physical process measurements and controls should be employed to validate sterilization processes.

WARNING: Use BT20S biological indicator only for the control of Steam, Formaldehyde, Hydrogen Peroxide and/or Peracetic Acid sterilization processes. Do not use for other processes such as Ethylene Oxide, Dry Heat and/or Radiation sterilization.

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 product 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. Vortex vial before each use.

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

a) If syringe is used, disinfect stopper surface and pull syringe plunger halfway back. Insert needle through stopper, push plunger in, and then slowly withdraw plunger to fill syringe to desired volume.

b) If a pipette is used, remove stopper and insert pipette. Dispense the desired volume.

6. Inoculate the product appropriately. The area to be inoculated should be the most difficult for the sterilizing agent to penetrate.

7. Identify the inoculated samples.

8. Distribute €œInoculated Test Samples throughout the sterilizer load.

9. After sterilization cycle is completed, test the inoculated products as soon as possible using an appropriate culture medium, and incubate at 60 °C. We suggest Bionova® MC20-2 or MC1020-2 media to final reading at 24 hours for Steam/Hydrogen Peroxide sterilization and at 48 hours for Formaldehyde sterilization. For conventional culture medium like TSB, incubation for 7 days at 60 °C is recommended.

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

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