Microbiology and Sterility

From a diabetic infusion set to hip and knees implants,  medical devices cover a very broad and complex variety of technologies. Since devices have a very broad spectrum of products, so are tests and testing requirements for safety. Eurofins Medical Device Testing has been assisting Medical Device customers with their microbiological and sterility testing needs for over 30 years.
 

Overview of our services

  • Validation of your sterilization process
  • Validation of your cleaning and reprocessing procedures for reusable devices and instruments
  • ​Conduct routine microbiological analyses and validation of method
  • Bioburden
    Aerobic/ Anaerobic bacteria, Yeasts and Molds
  • Pyrogen & Endotoxin Testing:
    LAL test (Kinetic method, Gel Clot, Chromogenic method), pyrogen and MAT Test)
  • Sterility test
    Direct transfer method and membrane filtration method
  • Sterilization verification, sterilization validation
    Ethylene Oxide, Gamma Radiation, E-beam, Dry heat, Moist Heat, etc. Process validation using Bio-indicators or through Bioburden and Sterility testing (irradiation)
  • Analysis of Bioindicators
  • Identification of Microorganisms
    MALDI-TOF MS or genotypic identification
  • Environmental Monitoring
    Establishing the monitoring and sampling plan, perform sampling, viable particle count, house flora determination
  • Water production Analysis
    Microbiological and chemical control


If you would like more information about our Medical Device testing capabilities, please also visit our global Medical Device website using the following link: https://www.eurofins.com/medical-device/

 


Questions? Call us now

+31622477880