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Microsart® Validation Standard Kocuria rhizophila

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.:  SMB95-2007

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:微生物质量控制产品精简目录
zh 2.4 MB
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

User Manual

Microsart® Validation Standard - For the validation of bacteria species (excluding mycoplasma)
en 900.4 kB

Applications

  • Application
    Bacteria Detection

Biological Information

  • Species
    Kocuria rhizophila

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

Product Information

  • Pack Size
    6
  • Primary Product Type
    Kits & Assays
  • What you receive
    • 6 vials with 99 CFU lyophilized
    • 2 vials negative control lyophilized

Specifications

  • Detection Method
    PCR
Microsart® ATMP Extraction
Microsart® ATMP Extraction
Item no.: SMB95-2001

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 Bacillus subtilis

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 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 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 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 ATMP Sterile Release

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 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).

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