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Microsart® Validation Standard Penicillium chrysogenum

Microsart® Validation Standard are used for validating robustness and sensitivity of NAT-based detection methods, to be used for contamination control of cell cultures, cell culture media components and cell culture derived biologicals like cell autologous transplants and ATMPs.

Item no.:  SMB95-2040

 

Microsart® Validation Standards are not infectious and therefore safe in use. They are titrated to 99 CFU/ml, the sensitivity limit for sterility tests according to European Pharmacopoeia (EP) 2.6.1 Sterility. The fungal strains used for the manufacture of Microsart® Validation Standard are low passage reference strains cultivated in suitable culture broth. The cultures are harvested in the early logarithmic phase of the growth to avoid an atypical high ratio of dead fungal cells as well as a high GC:CFU-ratio.

Catalog

Products for Microbiological Control
en 12.0 MB

Applications

  • Application
    Fungal Detection

Biological Information

  • Species
    Penicillium chrysogenum

Compliance Information

  • Regulatory Requirements
    For EP 2.6.1 and 2.6.27 compliant validation

Components

  • Additional Required Components
    • qPCR cycler
    • PCR reaction tubes
    • Centrifuge for 1.5 ml PCR tubes
    • Pipettes
    • Extraction Kit
    • PCR kit

General Specifications

  • Detection Method
    PCR

Product Information

  • Brand
    Microsart®
  • Pack Size
    6
  • What you receive
    • 6 vials with 99 CFU lyophilized
    • 2 vials negative control lyophilized
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