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Microsart® Validation Standard Aspergillus fumigatus

 
Microsart® Validation Standard Aspergillus fumigatus 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.

Item no.:  SMB95-2039

 

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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
    Aspergillus fumigatus

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

  • 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
Microsart® Validation Standard Candida albicans
Microsart® Validation Standard Candida albicans
Item no.
SMB95-2037

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 Candida glabrata
Item no.
SMB95-2041

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 Aspergillus brasiliensis
Microsart® Validation Standard Aspergillus brasiliensis
Item no.
SMB95-2038

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 Penicillium chrysogenum
Item no.
SMB95-2040

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 Candida tropicalis
Item no.
SMB95-2043

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 krusei
Microsart® Validation Standard Candida krusei
Item no.
SMB95-2042

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 Aspergillus fumigatus
Microsart® Calibration Reagent Aspergillus fumigatus
Item no.
SMB95-2046

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® ATMP Sterile Release Detection Kit
Microsart® ATMP Sterile Release Detection Kit
Item no.
SMB95-1007

Microsart® ATMP Sterile Release is designed to rapidly detect total bacteria and fungi in cell cultures, cell culture-derived biologicals, and ATMPs. The technology is based on real-time polymerase chain reaction (PCR).

Top Features of Microsart® ATMP Sterile Release

  • Rapid detection of critical bacterial and fungal contaminants within three hours
  • 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)