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Microsart® Validation Standard Bacillus subtilis

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.:  SMB95-2005

Availability (ex works):  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).

Brochure

宣传手册:微生物质量控制产品精简目录
zh 2.4 MB
宣传手册:微生物限度检测产品
zh 5.1 MB

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

Applications

  • Application
    Bacteria Detection

Biological Information

  • Species
    Bacillus subtilis

Compliance Information

  • Regulations
    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

Product Information

  • Pack Size
    6
  • Primary Product Type
    Kits & Assays
  • What you receive
    • 6 vials with 99 CFU lyophilized
    • 2 vials negative control lyophilized

Specifications

  • Detection Method
    PCR

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