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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.

Item no.:  SMB95-2037

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

Biological Information

  • Species
    Candida albicans

Compliance Information

  • Regulatory Requirements
    For EP 2.6.1 and 2.6.27 compliant validation

General Specifications

  • Detection Method
    PCR

eShop Dynamic Attributes

  • Additional Required Components
    • qPCR cycler
    • PCR reaction tubes
    • Centrifuge for 1.5 ml PCR tubes
    • Pipettes
    • Extraction Kit
    • PCR kit
  • Application
    Fungal Detection
  • Pack Size
    6
  • What you receive
    • 6 vials with 99 CFU lyophilized
    • 2 vials negative control lyophilized
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Microsart ATMP Bacteria (100)
Microsart ATMP Bacteria (100)
Item no.: SMB95-1008

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Microsart® Validation Standard Candida glabrata

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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.

Microsart ATMP Sterile Release
Microsart ATMP Sterile Release
Item no.: SMB95-1007

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

Microsart® Validation Standard Aspergillus brasiliensis

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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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 albicans

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

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.