Spore Suspensions

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
Ref #VolumePopulation
VBA-10210mL102
VBA-10310mL103
VBA-10410mL104
VBA-10510mL105
VBA-10610mL106
VBA-10710mL107
VBA-10810mL108
VBA-10910mL109

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TDS – Spore Suspensions – B_atrophaeus Cell Line 9372 (VBA-10x) Rev. 1.0
Technical Data Sheets (TDS)
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