Microbiology and Sterility

We offer our customers comprehensive microbiology studies for drug and medical device testing as well as for environmental monitoring and production safety.

With many years of experience and a highly qualified team of scientists and technicians, we help our customers to meet their specific requirements with standardised test systems or customised studies.

What do we offer?

Microbiological test systems can be used for quality control of raw materials, bulk products, finished products and storage studies as well as validation of the plant and production process. In addition, numerous study designs are available for product development.

Our scientists are available to advise the customer in the preliminary stages as well as throughout the project until successful completion.

Due to their profound knowledge of current guidelines (ISO, DIN, EN, Pharmacopoeia, AAMI, ANSI, ASTM etc.) as well as regular participation in international working groups and congresses, our experts are always up to date with current trends and regulatory issues.

Whether your requirements are straightforward or complex, we can help you with a bottleneck, a special issue or simply as an external microbiology laboratory.

Overview of our services

• Validation of your cleaning and reprocessing procedures for reusable devices and instruments
• Validation of depyrogenation processes
• ​Conduct routine microbiological testing and validation of methods
• Bioburden (Aerobic/ Anaerobic bacteria, Yeasts and Moulds)
• Special microorganisms / microbial limit test
• Antimicrobial efficacy tests
• Pyrogen & Endotoxin Testing (LAL test (Kinetic method, Gel Clot, Chromogenic method), Pyrogen and MAT Test)
• Sterility testing (Direct transfer method and membrane filtration method)
• Validation of sterilisation processes (Ethylene Oxide, Gamma Radiation, E-beam, Dry heat, Moist Heat)
• Analysis of Bioindicators
• Identification of Microorganisms (MALDI-TOF MS or genotypic identification)
• Environmental Monitoring
• Water system validation (Microbiological and chemical control)

Why choose Eurofins Medical Device Services?

• Single point of contact. Benefit from streamlined communication through a single local point of contact while leveraging the advantages of our extensive global network.
• Complete service portfolio. Leveraging our network of regulatory experts, laboratories, and sterile packaging sites in Europe, North America, & Asia Pacific, we can offer a comprehensive service portfolio to our customers.
• Extensive expertise. Companies of all sizes benefit from our 40+ years of expertise and capabilities to ready their products for market launch and post-marketing activities through three independent services: consulting, testing, and sterile packaging.

If you would like to discuss your project and needs with our Business Development Manager Anja Kroon or request a quotation, feel free to contact us.

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/