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Microsart® Validation Standard Bacillus subtilis

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.:  SMB95-2005

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 bacteria 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 bacteria and plated on Agar medium for quantification based on Colony-forming Units (CFU).

Brochure

宣传手册:微生物限度检测产品
zh 5.1 MB
宣传手册:微生物质量控制产品精简目录
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Catalog

Products for Microbiological Control
en 12.0 MB

User Manual

Microsart® Validation Standard
en 534.0 kB

 

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

 

  • Application
    Bacteria Detection
  • Pack Size
    6
  • Regulatory Requirements
    For EP 2.6.1 and 2.6.27 compliant validation
Microsart® Calibration Reagent Staphylococcus aureus

$405.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.

Microsart® Calibration Reagent Kocuria rhizophila

$405.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.

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® Calibration Reagent Bacteroides vulgatus

$405.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.

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® Calibration Reagent Clostridium sporogenes

$405.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.

Microsart® Calibration Reagent Bacillus subtilis

$405.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.

Microsart® Calibration Reagent Pseudomonas aeruginosa

$405.00

Microsart® Calibration Reagents are isolated genomic DNA preparations, containing 10^8 genome copies of a specific bacterial species per vial.

Microsart ATMP Sterile Release

$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).