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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

Price:  $405.00

Availability (ex works):  For more information please log in

   

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 albicans
  • 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
Microsart® Validation Standard Candida krusei

$405.00

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

$3,820.00

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 Candida glabrata

$405.00

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 Extraction
Microsart® ATMP Extraction
Item no.: SMB95-2001

$765.00

Microsart® ATMP Extraction kit introduces a state-of-the-art (DNA-free) method for DNA extraction from cell cultures and cell culture derived biologicals, like autologous transplants and other advanced therapy medicinal products (ATMP), for subsequent DNA amplification via PCR (e.g. Microsart ATMP Bacteria and Fungi qPCR Kits).

Microsart® Validation Standard Aspergillus fumigatus

$405.00

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

$1,275.00

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

$405.00

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

$405.00

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

$410.00

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

$405.00

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.