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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:  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 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.

Brochure

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

 

  • Additional Required Components
    • qPCR cycler
    • PCR reaction tubes
    • Centrifuge for 1.5 ml PCR tubes
    • Pipettes
    • Extraction Kit
    • PCR kit
  • Detection Method
    PCR
  • Species
    Candida krusei
  • What you receive
    • 6 vials with 99 CFU lyophilized
    • 2 vials negative control lyophilized

 

  • Application
    Fungal Detection
  • Pack Size
    6
  • Regulatory Requirements
    For EP 2.6.1 and 2.6.27 compliant validation
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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.

Microsart® Validation Standard Candida albicans

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.

Microsart® Validation Standard Candida glabrata

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.

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.

Microsart® Validation Standard Penicillium chrysogenum

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.

Microsart® Calibration Reagent Candida krusei

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^6 genome copies of a specific fungal species per vial.

Microsart ATMP Bacteria (100)
Microsart ATMP Bacteria (100)
Item no.: SMB95-1008

Microsart® ATMP Bacteria kit is designed for the direct detection of bacteria in cellcultures, cell culture derived biologicals and ATMPs (e.g. autologous transplants),based on real-time PCR (qPCR).

Microsart® Validation Standard Aspergillus fumigatus

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.

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