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Dry Heat Biological Indicators

Crosstex offers a comprehensive product line of Biological Indicators (BIs) used to monitor Dry Heat sterilization processes.  Our BIs and Prepared Culture Media are designed to meet ISO 11138 and USP standards. Crosstex Biological Indicators for Dry Heat sterilization are:

  • Used to evaluate the efficiency of Dry Heat sterilization processes
  • Essential in performing sterilization cycle validation during Dry Heat sterilization processes
  • Easy to use and require minimal training
  • Available in different populations, packaging, and configurations. Custom BIs are also available
  • Validated with a reduced incubation time of 48 hours, when used in conjunction with Crosstex’ Prepared Culture Media
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Bio ind bac atro 6log glas 100 pces iso
BG-106DH

Crosstex offers a biological indicator for Dry Heat sterilization which is compliant with ISO 11138-4.
Biological Indicator Spore Strips for monitoring Dry Heat processes consist of:

- An inoculated carrier, 7 mm x 38 mm (1.5” x 0.281”) strip, of Bacillus atrophaeus (Cell Line 9372)

- Primary packaging in a white glassine pouch

Physical Properties 

Process Dry Heat
Strip Dimensions 7 mm x 38 mm (1.5” x 0.281”)
Glassine Dimensions 25 mm x 75 mm
Packaging 100/Box

 

Monitoring Frequency
For greatest control of sterilized goods, it is recommended that a minimum of ten (10) Spore Strips be included with every load.


Performance Characteristics 

Population 1.0 to 5.0 x 106 per strip
Purity

No evidence of contamination present in sufficient numbers to adversely affect the finished product. 

Dry Heat Resistance

D value at 160°C ± 1°C ≥2.5 minutes

The Dry Heat D value is based on the requirements outlined in ISO 11138-4.

Survival – Kill Times Calculated based on the formulations outlined in the USP and ISO 11138-1.

z value ≥20°C

Determined based on three temperatures in the range of 150°C to 180°C. Crosstex typically utilizes D values determined at 150°C, 160°C and 170°C for z value calculation.

Post-Market Criteria

Population: 50% to 300% of certified population

D value: ± 20% of the certified D value

Survival Time: All Spore Strips result in growth at the certified survival time

Kill Time: All Spore Strips result in no growth at the certified kill time

 

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