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
||7 mm x 38 mm (1.5” x 0.281”)
||25 mm x 75 mm
For greatest control of sterilized goods, it is recommended that a minimum of ten (10) Spore Strips be included with every load.
||1.0 to 5.0 x 106 per strip
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.
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