Eurofins BioPharma Product Testing Netherlands (EBPT NL), fully GMP and ISO 13485 certified, provide Microbiological QC-testing solutions for raw materials, drug substances, drug products and medical devices. Whether you need to ensure sterility, determine antimicrobial effectiveness, microbial contamination, analyze endotoxins or identify flora from your environmental monitoring processes, we are here to help.
Routine Testing as per PhEur/USP
The following tests are only a small part of our testing services and performed routinely on a large scale basis. We offer various additional services surrounding these processes. If you have any questions regarding our services, please do not hesitate to contact us to find out whether we can help.
- Biological assays of antibiotics
- Efficacy of antimicrobial preservatives (challenge testing)
- Microbial identification
- Mycoplasma testing
- Mycobacterium testing
- Sterility membrane filtration
- Sterility direct inoculation
- Total Aerobic Microbial Count (TAMC)
- Total Yeasts and Moulds Count (TYMC)
- Test for specified micro-organisms
- Bacterial Endotoxins (LAL), kinetic turbidimetric
- Bacterial Endotoxins (LAL), kinetic chromogenic
- Bacterial Endotoxins (LAL), gel-clot
Validation of analytical methods per PhEur/USP
Not only can we assist you with routine QC testing, we also offer method development and validation services as per PhEur/USP. A validation project comprises a study plan, study design, performance of analytical work and subsequent data handling. All data is presented in a detailed study report.
Except for product testing we can also help you monitor your clean / aseptic areas to ensure that daily operations are not negatively influencing the required cleanliness level. Environmental Monitoring is a critical assessment of the performance of your employees, machines, process etc. Eurofins can help you setting up a customized Environmental Monitoring Program and perform the required monitoring and testing:
- active air sampling
- passive air sampling
Except for the determination of the bioburden level in your clean areas, it is also important to know what your house flora is. This should be continuously under review (annually) and be monitored on a regular basis as house flora may change during the different seasons.
House flora is also used to validate disinfectants, and during simulations of your products process (media fill).
Why choose Eurofins BioPharma Product Testing
- Single-point-of-contact. Eurofins BioPharma Product Testing Netherlands has all expertise within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins BioPharma Product Testing Netherlands has several complementary companies, all this expertise is brought together in one multidisciplinal organization.
- Standard and custom solutions. If our standard solutions do not fulfill your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.