The microbiological analysis of non-sterile pharmaceutical products is required as release and shelf-life specification according to the Chapter 5.1.4. Microbiological Quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use of European Pharmacopoeia.
What is needed for these studies?
In order to guarantee the compliance of the product specifications, it is necessary to carry out the microbiological test depending on the finished dosage form: not only the total aerobic microbial count (TAMC) and the total yeasts and moulds count (TYMC) but also the specific microorganisms (such as Escherichia coli, Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus, Clostridia, Candida albicans or bile tolerant gram negative bacteria), according to the Chapters 2.6.12 Microbiological examination of non-sterile products: microbial enumeration test and 2.6.13. Microbiological examination of non-sterile products: test for specified micro-organisms of European Pharmacopoeia.
For the microbiological analysis of non-sterile pharmaceutical products, qualified microbiological incubators and qualified equipment and tools (e.g. laminar flow cabinet, filtration equipment, etc.) are needed. Additionally, the GMP certification is also necessary.
What Netpharmalab offers to you…
At Netpharmalab we carry out the microbiological analysis of non-sterile pharmaceutical products, both quantitative and qualitative, as well as the identification of isolated microorganisms.
Additionally, we may perform these analyses on medical devices and food supplements with the same reliability.