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Eurofins Reg Ag, offer a full range of GLP and efficacy testing services as part of a complete registration solution for your biocidal products.

Medical Devices - Microbiology

Thanks to the well equipped microbiology departments of BSL BIOSERVICE (Partner lab) and Eurofins Biolab Italy, Eurofins is covering all microbiological test systems for quality control of raw materials, finished products and the validation of the production process. Furthermore, a broad range of studies for the product development e.g. preservative testing, infection studies as well as the determination of antimicrobial efficacy are available.

A set of microbiological and biochemical methods necessary for performance qualification of sterilization processes and for validation of reprocessing procedures of reusables complete the service of Eurofins. Whether your demands are small or great we are prepared to meet all your requirements.

Microbiology test panel:

Petri Dish

  • Bioburden

    • Bacteria and yeasts / moulds
    • Identification of microorganisms
    • Validation of bioburden estimation
  • Environmental monitoring

    • Establishment of a hygienic program including sampling plan
    • Sampling
    • Particle count
    • Microbial count of air
    • Microbial count of surfaces, personal
    • Identification of microorganisms
  • Examination of production water

    • Microbial count
    • Specific microorganisms
    • Endotoxins
  • Pyrogenicity / endotoxins

    • LAL test (gel clot, turbidimetric technique)
    • Pyrogen test (partnered service)
    • Monocyte activation assay
    • Validation of depyrogenation with dry heat using endotoxins
  • Test for sterility

    • Within validation of sterilization process
    • As batch release test (facultatively)
  • Identification of microorganims

    • Macroscopically and microscopically examination
    • Biochemical determination (API)
    • Molecular biological determination (partnered service)
  • Evaluation of bioindicators

    • Providing of all types of bioindicators (produced by a partner)
    • Evaluation of quality (test for microbial count and identity)
    • Evaluation after application of the sterilization process (qualitative, quantitative)
  • Sterilization processes

    • Ethylene oxide, irraditation, moist heat, dry heat etc.
    • Performance qualification using bioindicators (EtO, moist heat etc.) or testing bioburden, sterility (irradiation)
  • Test for antimicrobial efficacy

    • Antimicrobial preservative testing
    • Proliferation assay (antimicrobial efficacy of coated surfaces)
    • Antibiotics assay
    • Test for growth inhibition on agar plates or in media (standardized or tailor-made studies)
  • Evaluation of reusables for the applied cleaning,disinfection and sterilization procedure

    • Manual cleaning and / or disinfection
    • Automatic cleaning and / or disinfection
    • Sterilization (moist heat, ethylene oxide, plasma)
    • Microbiological and biochemical methods

For further information please contact us:

Updated by: bdqu
Last updated: 14 October 2013