Eurofins Sinensis, fully GMP 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, analyse 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 hestitate to contact us to find out whether we can help.
- Biological assays of antibiotics
- Efficacy of antimicrobial preservatives
- Microbial identification
- Mycoplasma testing
- Mycobacterium testing
- Sterility membrane filtraton
- Sterility direct inoculation
- Total Aerobic Microbial Count (TAMC)
- Total Yeasts and Moulds Count (TYMC)
- Test for specified micro-organisms
- Tests for bacterial endotoxins (LAL)
Validation of analytical methods per PhEur/USP
Not only can we assist you with routine QC testing, we also offer analytical 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.
Finally, we offer process validations for manufacturing, filling, sterilizing and packaging.
- Microbial validation of sterilization with gamma irradiation (ISO 11137-2)
- Validation of aseptic mediafills of health care products (ISO 13408)
- Clean room classification & Environmental Monitoring (GMP, ISO 14644/14698)
- Microbial and physical testing of medical grade gases (EN 737 and PhEur / GMP)
- Disinfectants and antiseptics testing
- Stability studies for Medical Device Industry
- Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
- All services available internally. As Eurofins Sinensis is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
- Standard and custom solutions. If our standard solutions do not fullfil your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.