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irrad

Spore Suspensions

Crosstex manufactures Spore Suspensions utilized in Gamma & E-Beam sterilization processes. The Spore Suspensions are pure suspensions of spores with known radiation 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.

  • 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

Spore Suspensions – 10 mL

Crosstex Code Population per 0.1 mL
VBP-106 106
VBP-107 107
VBP-108 108
Process Radiation (Gamma and E-Beam)
Organism Bacillus pumilus Cell Line 27142
Indications for Use Crosstex Spore Suspensions are standardized suspensions of spores appropriate for direct inoculation onto samples for sterility, bioburden, and bacteriostasis testing.

This product is 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

Shelf Life 24 months from the date of manufacture
Storage Conditions Refrigerate at 2°C to 8°C