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Spore suspen b atropheus 9372 6log 10ml

VBA-106
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Description

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
OrganismBacillus atrophaeus Cell Line 9372
Indications for UseCrosstex 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 Volume10 mL Diluent contains 20% ethanol
PackagingPharmaceutical grade glass vial with screw cap and septum
ComplianceISO 11138-1 Sterilization of health care products – Biological indicators – Part 1: General requirements USP (where applicable)
Shelf Life18 months from the date of manufacture
Storage ConditionsRefrigerate at 2°C to 8°C
Population per 0.1 mL106
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VBA-106
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