200Bozeman-SuspensionsMedium

Les suspensions de spores Mesa calibrées, sont utilisées en inoculation directe pour valider le cycle de stérilisation d’un dispositif ou d’un liquide. Le choix de la souche bactérienne et de la population dépend du procédé et du challenge de stérilisation souhaités : Les spores sont en suspension dans une solution d’éthanol à 40% ou d’eau selon l’utilisation. Chaque flacon contient 10 ml de suspension et la population est annoncée pour 0,1 ml.

En règle générale on utilise les suspensions dans l’éthanol pour l’inoculation de dispositifs (séchage rapide) et dans l’eau pour les solutions aqueuses.

  •  Autres suspensions sur demande : (Flacons de 10 ml) subtilis « 5230 » (vapeur basse température), B. subtilis « 6633 » (pour test de fertilité), B. cereus, Clostridium sporogenes, B. coagulens, B. smithii (formerly B. coagulens), B. megaterium B. thuringeinsis, B. licheniformis

Technical Specifications

Storage*: Refrigerate at 2 to 8°C *BMF 40% Ethanol: freeze at -25 to -10°   Expiration*: 12 months from date of manufacture *BMF 40% Ethanol: 24 months from date of manufacture   Certification: Spore suspensions are traceable to a recognized culture collection and certified for population, D-value, and z-value (steam).

Species

Species

Mesa manufactures many species of non-pathogenic spore-forming bacteria. Most are used for various types of sterilization, though some have other uses. Following is a brief description of the most common uses:

  • G. stearothermophilus* (reference # 7953) for steam, B. atrophaeus* (reference # 9372) for dry heat and EO and B. pumilus* (reference # 27142) for gamma irradiation are standard products.
  • B. subtilis* (reference # 6633) – Used to test the growth promotion ability of bacteriological media (specified in USP and other compendial monographs). We do not certify this organism with any resistance characteristics.
  • B. subtilis* (called “Designate 5230”) is used in steam sterilization procedures below 121° C. Some pharmaceutical products are sterilized at 106° to 115° C for longer times because they are heat labile and would be damaged at 121°C or higher temperatures. This species has been used as a challenge to the lower temperatures in steam, where G. stearothermophilus would be too great a challenge. In using a lesser challenge (C. sporogenes species and environmental isolates are also used) it is necessary to have an extremely high level of control over the manufacturing process, environment, and bioburden of components. This organism is certified with a Steam D and z-value so its resistance at the lower temperatures can be determined.
  • G. stearothermophilus* (reference # 12980) is widely used in the validation of Hydrogen Peroxide (H2O2) vapor sterilization of barrier isolators and clean areas in pharmaceutical production. This species is typically inoculated onto steel carriers so it is compatible with the H2O2 process and similar in material to items typically found in these production areas. This organism is certified with an H2O2 D-value.
  • G. stearothermophilus* (reference # 10149) is used to detect residual antibiotics in dairy products. This organism is not certified for any resistance characteristics.
  • B. thuringiensis* (reference # 29730) – This species has a protein crystal on the spore coat that makes the spores toxic to various insect larvae. In some areas, trees are sprayed with a spore suspension to protect them from certain larvae. Geneticists have engineered this protein to be expressed in some varieties of corn (referred to as Bt-corn). B. thuringiensis has also been used as a surrogate to B. anthracis or other more hazardous organisms in testing decontamination processes. We do not certify this organism with any resistance characteristics.
  • B. cereus and B. megaterium would be used in a similar manner to B. subtilis designate 5230 (lower temperature steam sterilization at 106° to 115°C). B. cereus is also used as a surrogate for B. anthracis and other more dangerous organisms in testing decontamination processes. We do not certify this organism with any resistance characteristics, but one can be provided upon request for a fee.