Pharma Analytics

Microbiology pharmaceuticals

Microbiological detection methods play a crucial role in the pharmaceutical industry, since they are applied in most steps starting with product development right up to final release by Quality Assurance. Here products are checked for sterility or for the absence of pathogenic germs which can trigger infections. Moreover, microbiological contamination of pharmaceuticals must remain under a defined threshold value. These strict regulations and laws are based on the respective pharmacopeias and Good Manufacturing Practice: the European Pharmacopeia (EP), the American Pharmacopeia (USP) and the Japanese Pharmacopeia (JP). The individual pharmacopeias have been harmonised in terms of determination methods so as to allow for globally consistent legislation. 

Institut für Produktqualität's parameters for the detection of microbiological analyisis are:

• Tests for microbial puritiy
• Validation for microbial purity
• Tests for efficient antimicrobial conservation
• Tests for bacterial endotoxins
• Validation for bacterial endotoxins
• Water analyses
• Monitoring sample analyses
• Identification of microorganisms