Microsart® Validation Standard Candida tropicalis

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Microsart® Validation Standard Candida tropicalis Microsart® Validation Standard Candida tropicalis
 

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.: 
SMB95-2043
Availability: 
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Microsart® Validation Standard Candida tropicalis
Microsart® Validation Standard Candida tropicalis

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.:
SMB95-2043
Availability: 
For more information please log in
Est. delivery date:
For more information please log in

Overview

Specifications

Choose your Microsart® Rapid Sterility Testing

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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 tropicalis

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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