Microsart® Validation Standard Pseudomonas aeruginosa

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.: 
SMB95-2006
Availability: 

*Custom/bulk order quotes are provided within 24 hours of request.

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).

Applications

  • Application
    Bacteria Detection
  • Application Area
    Rapid testing

Biological Information

  • Species
    Pseudomonas aeruginosa

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

  • Culture Media
    N/A
  • 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® 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 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® 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 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)

  • 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.

  • Share Your Thoughts!

    Help us amplify the customer experience by providing a review of your recently purchased Sartorius product.