Our microbiological unit is specialized in working with bacteria, bacterial viruses (Bacteriophages) and fungi. We combine classical microbiology like detection, enrichment, isolation and identification according to official standard methods with the possibilities of a molecular biological an immunological laboratory. We test raw materials, pharmaceutical products, bacterial cell banks, cosmetics, medical devices or patient samples within clinical assays.
- Determination of Bioburden ( Ph. Eur. 2.6.12, ISO 11737-1)
- Pyrogen determination:
- Bacterial endotoxin test (Ph. Eur. 2.6.14 ; Ph. Eur. 5.1.10)
- Monocyte activation test (Ph. Eur. 2.6.30)
- Microbiological examination of live biotherapeutic products (Ph. Eur. 2.6.36, Ph. Eur. 2.6.38)
- Purity testing of bacterial cell banks
- Bacteriophage analytics
- Determination of genotoxicity (AMES Test, OECD TG 471)
- Microbiological testing of cosmetics according to CTFA or ISO standards
TentaMedix is GMP certified and accredited according to the ISO 17025 by DAkkS and ZLG. In addition we offer GMP compliant method development, verification/validation and routine testing of your finished products, APIs, in-process controls of pharmaceutical products and biologics.
We hold the authorisation to handle microorganism at biosafety Level 2 (human and animal pathogens) and GMOs at biosafety level I.