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Microsart® Validation Standard Clostridium sporogenes

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.:  SMB95-2008

 

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).

Catalog

Products for Microbiological Control
en 12.0 MB

User Manual

Microsart® Validation Standard
en 534.0 kB

Applications

  • Application
    Bacteria Detection

Biological Information

  • Species
    Clostridium sporogenes

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

General Specifications

  • Detection Method
    PCR

Product Information

  • Brand
    Microsart®
  • Pack Size
    6
  • What you receive
    • 6 vials with 99 CFU lyophilized
    • 2 vials negative control lyophilized
Microsart® Calibration Reagent Bacteroides vulgatus

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

Microsart® Calibration Reagent Staphylococcus aureus

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

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

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

Microsart® Calibration Reagent Clostridium sporogenes

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

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 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 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)