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: 

*Custom/bulk order quotes are provided within 24 hours of 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).

Applications

  • Application
    Bacteria Detection
  • Application Area
    Rapid testing

Biological Information

  • Species
    Bacillus subtilis

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

Dimensions

  • Filter Diameter
    N/A

General Specifications

  • Culture Media
    N/A
  • Detection Method
    PCR
  • Membrane Color | Grid Color
    N/A

Materials of Construction

  • Filter Material
    N/A

Physicochemical Information

  • Pore Size
    N/A

Product Information

  • Brand
    Microsart®
  • Pack Size
    N/A
  • Type
    Reagents
  • What you receive
    • 6 vials with 99 CFU lyophilized
    • 2 vials negative control lyophilized
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