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Biological Indicators — ISO 11138-4 Compliant
Crosstex offers a biological indicator for Dry Heat sterilization which is compliant with ISO 11138-4.
- Consists of a 7 mm x 38 mm filter paper strip inoculated with Bacillus atrophaeus spores
- Primary packaging of a white glassine pouch
- The configuration offers an increased D value at 160°C of not less than 2.0 minutes meeting the requirements for dry heat resistance as outlined in ISO 11138-4
- Place BIs into the most difficult area of the sterilizer or device/article to be sterilized
- A reduced incubation time of 48 hours for Dry Heat Sterilization has been validated when used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)
| Ref # | Population | Quantity |
|---|---|---|
| BG-106DH | 106 | 100/box |
| Process | Dry Heat |
| Organism | Bacillus atrophaeus Cell Line 9372 |
| Indications for Use | The Spore Strips may be utilized for routine Dry Heat sterilization process efficacy monitoring, sterilizer qualification testing after installation, relocation, malfunctions, major repairs and sterilization process failures for Industrial applications. The Spore Strips are labeled For Industrial Use Only. |
| Strip Dimensions | 7 mm x 38 mm (1.5” x 0.281”) |
| Glassine Dimensions | 25 mm x 75 mm |
| Packaging | 100 Strips/Box |
| Compliance | ISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements
ISO 11138-4 Sterilization of health care products – Biological indicators – Part 4: Biological indicators for dry heat sterilization processes |
| Shelf Life | 24 months from the date of manufacture |
| Storage Conditions | 20°C to 25°C average. Excursions 15°C to 30°C allowed.
20-70% relative humidity |