
Microbiology for pharmaceuticals
Microbiological testing of non-sterile medicinal products is carried out according to the methods of the European Pharmacopoeia and in compliance with GMP regulations.
Medicinal products must meet high quality standards.
The microbiological safety of these products and formulations is of central importance. The European Pharmacopoeia (Ph.Eur.) specifies the criteria for this.
We support you with the following services:
Laboratory Testing
- Determination of total aerobic microbial count (TAMC) and total yeast and mold count (TYMC) according to Ph. Eur. 2.6.12
- Detection of specified microorganisms (e.g., Escherichia coli, Pseudomonas aeruginosa, Salmonella, Staphylococcus aureus) according to Ph. Eur. 2.6.13 and 2.6.31
- Bioburden testing according to ISO 11737
- Product-specific suitability tests (validations)
- Testing for adequate antimicrobial preservation (challenge tests)
- Testing according to Ph. Eur., USP, and customer specifications (method development)
- Water Testing
- Environmental Testing and Monitoring
Additional Services
- Plant and hygiene inspections
- Statements and expert opinions
- Training and events in-house/on-site