Microbiology
Our microbiological department specialises in detecting microorganisms such as aerobic and anaerobic bacteria, bacterial viruses (bacteriophages) as well as yeasts and moulds. We use classical microbiological methods of enrichment, isolation and identification of specific microorganisms to examine the sterility of raw materials, intermediate products and ready-to-use batches of medical devices.
At Tentamus Pharma & Med, we perform microbiological tests such as pyrogen determination for each monocyte activation test or bacterial endotoxin tests in a GMP-compliant manner in accordance with the standards and specifications of classical pharmacopoeial tests.
Microbiological testing
for medical devices
We carry out clinical assays for the following purposes:
- Determination of bioburden (Ph. Eur. 2.6.12, ISO 11737-1)
- Detection of specific bacteria (Ph. Eur. 2.6.13)
- Pyrogen determination:
- bacterial endotoxin test (Ph. Eur. 2.6.14)
- Monocyte activation test (Ph. Eur. 2.6.30)
- Microbiological testing of cosmetics in accordance with CTFA or ISO standards