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Microsart® Validation Standard Kocuria rhizophila

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.:  SMB95-2007

Availability:  On Request

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 bacteria 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 bacteria and plated on Agar medium for quantification based on Colony-forming Units (CFU).

Catalog

Products for Microbiological Control
en 12.0 MB

User Manual

Microsart® Validation Standard - For the validation of bacteria species (excluding mycoplasma)
en 900.4 kB

Product properties

  • Primary Product Type
    Kits & Assays
  • Pack Size
    6
  • Species
    Kocuria rhizophila

Technical attributes

  • What you receive
    • 6 vials with 99 CFU lyophilized
    • 2 vials negative control lyophilized
  • Application
    Bacteria Detection
  • Regulations
    For EP 2.6.1 and 2.6.27 compliant validation
  • Detection Method
    PCR
  • Additional Required Components
    • qPCR cycler
    • PCR reaction tubes
    • Centrifuge for 1.5 ml PCR tubes
    • Pipettes
    • Extraction Kit
    • PCR kit

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