Microbiological tests on non-sterile medical drugs are run in accordance with the methods set forth in the European Pharmacopoeia (Ph. Eur.) and in consideration of the GMP regulations (GMP certificate by the Regierungspräsidium Tübingen; a regional authority).
They include in particular:
- colony counting (e.g. the total number of aerobic micro-organisms (TAMC), the total number of yeasts and mildew (TYMC)…)
- detection of specific micro-organisms (e.g. Escherichia coli, Pseudomonas aeruginosa, salmonellae, Staphylococcus aureus…)
- tests for sufficient preservation (stress tests)
- product-specific validations
- purified water
