Microsart® Validation Standard Candida krusei

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Microsart® Validation Standard Candida krusei Microsart® Validation Standard Candida krusei
 

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.: 
SMB95-2042
Availability: 

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

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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.

Applications

  • Application
    Fungal Detection
  • Application Area
    Rapid testing

Biological Information

  • Species
    Candida krusei

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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    Top Features of Microsart® ATMP Sterile Release

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    • Designed for contamination control of ATMPs or short shelf-life applications
    • The PCR kit is validated according to EP 5.1.6, EP 2.6.27, USP 1223

    Popular Applications

    • Lab research
    • Quality control (QC)

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