Crosstex manufactures Biological Indicators (BIs) for use in monitoring Ethylene Oxide (EO) and Dry Heat sterilization processes. Biological Indicator Spore Strips for monitoring EO and Dry Heat processes consist of:
- An inoculated carrier, 7 mm x 38 mm spore strip, of Bacillus atrophaeus (Cell Line 9372)
- Primary packaging of a white glassine pouch
- Products are accompanied by a Certificate of Analysis and are certified with population, purity, and resistance characteristics (D value, survival and kill where applicable)
- A reduced incubation time of 48 hours for Dry Heat Sterilization and 72 hours for Ethylene Oxide (EO) sterilization have been validated when Crosstex Biological Indicator Spore Strips, Discs, Threads and Wires are used in conjunction with Crosstex Prepared Culture Media (GMBTB-100)
| Processes | EO / Dry Heat |
| Organisms | Bacillus atrophaeus Cell Line 9372 |
| Indications for Use | The Spore Strips may be utilized for routine EO and Dry Heat sterilization process efficacy monitoring, sterilizer qualification testing after installation, relocation, malfunctions, major repairs and sterilization process failures for both Healthcare and Industrial applications. Crosstex Codes BG-102, BG-103, BG-104 and BG-105 are labeled For Industrial Use Only. |
| Strip Dimensions | 7 mm x 38 mm |
| 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 requirementsFor Crosstex Codes BG-106, BG-107 and BG-108: ISO 11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes
USP <55> Biological Indicators – Resistance Performance Tests USP Biological/Official Monographs |
| Shelf-Life | 24 months from the date of manufacture |
| Storage Conditions | 15°C to 30°C, 20-70% relative humidity |