Crosstex manufactures a wide range of Spore Suspensions utilized in Ethylene Oxide (EO) and Dry Heat sterilization processes. The Spore Suspensions are pure suspensions of spores with known resistance characteristics and a variety of population levels standardized per 0.1 mL. The Spore Suspensions allow for direct inoculation of products, typically to verify sterility of devices where a traditional biological indicator spore strip cannot be used. They can also be used for a variety of other microbiological tests including cleaning effectiveness studies, Bioburden percent recovery and Bacteriostasis/Fungistasis (BF) testing.
Each vial contains 10 mL of suspension. Diluent contains 20% ethanol
Pharmaceutical grade glass vials with screw cap and septum
Spore Suspensions require storage under refrigerated conditions (2°C to 8°C)
Each vial of Spore Suspension is accompanied by a Certificate of Analysis detailing the source, assayed population, resistance characteristics on paper carrier and expiration date
ISO 11138-1 Compliant
|Process ||EO / Dry Heat
|Organism||Bacillus atrophaeus Cell Line 9372
|Indications for Use||Crosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing.
Spore Suspensions are labeled For Industrial Use Only.
|Suspension Volume||10 mL
Diluent contains 20% ethanol
|Packaging||Pharmaceutical grade glass vial with screw cap and septum
|Compliance||ISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements
USP (where applicable)
|Shelf Life||18 months from the date of manufacture
|Storage Conditions||Refrigerate at 2°C to 8°C
|Population per 0.1 mL||104
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