Microbiology
As a GMP-certified laboratory, we operate in accordance with current ISO standards and OECD guidelines and are authorised to handle biosafety level 2 microorganisms (human and animal pathogens) and biosafety level 1 GMOs.
Our microbiological department specialises in detecting aerobic and anaerobic bacteria, bacterial viruses (bacteriophages) as well as yeasts and fungi. Our pharmaceutical quality control combines classical microbiological methods with the capabilities of a molecular biological and immunological laboratory, allowing us to prepare informative quantitative and qualitative bioburden assays.
We use microbiological in vitro analysis to perform quality control for biopharmaceuticals and other pharmaceuticals and to test raw materials, pharmaceutical products and bacterial cell banks for microbial impurities and residues.
Microbiology
for pharmaceutical and biopharmaceutical quality control
Microbiological in vitro analysis
- Microbiological examination of non-sterile products: microbial enumeration tests (Ph. Eur. 2.6.12)
- Microbiological examination of non-sterile products: test for specified micro-organisms (Ph. Eur. 2.6.13)
- Microbiological examination of specific products:
- Microbiological examination of cell-based preparations (Ph. Eur. 2.6.27)
- Microbiological examination of herbal medicinal products for oral use and extracts used in their preparation (Ph. Eur. 2.6.31)
- Microbiological examination of live biotherapeutic products (Ph. Eur. 2.6.36, Ph. Eur. 2.6.38)
- Microbiological testing of cosmetics according to CTFA or ISO standards
- Identification of isolates (16S rRNA-DNA, ITS sequence, MALDI-TOF)
- Determination of bactericidal, fungicidal or yeasticidal activity of antiseptic medicinal products (Ph. Eur. 5.1.11)
Pyrogen determination
- Bacterial endotoxins (Ph. Eur. 2.6.14)
- Method B Gel-clot method: quantitative test
- Method C Turbidimetric kinetic method
- Method D Chromogenic kinetic method
- Monocyte-activation test (Ph. Eur. 2.6.30)
- Test for endotoxin using recombinant factor C (Ph. Eur. 2.6.32) – Coming soon.
Purified water analysis (Aqua purificata, WFI)
- Microbiological monitoring using R2A Agar
- Total organic carbon (TOC, Ph. Eur. 2.2.44)
- Endotoxins (Ph. Eur. 2.6.14)
- Elemental impurities (e.g. Nitrates, Aluminium)