Objectives/Brochure

Microbial contaminations poses enormous risks to pharmaceuticals and their consumers. To minimize the safety risk, pharmaceutical and biopharmaceutical manufacturers take thousands of samples a year with following incubation, counting of colonies and identification of micro organisms. The traditional culture methods need a long processing time and in the fields of cell culture, tissues and tissue engineering it is often not possible to wait 7 or more days for a result. RMM provide the ability to reduce time and costs for microbial detection. The increasing interest of pharmaceutical and biopharmaceutical companies in rapid microbiological methods caused a rapid development in the field of RMMs.

Several new systems for real-time microbial identification of samples from environmental monitoring, sterility testing, for mycoplasma detection, bacterialendotoxin testing are available at the market or in validation. The regulatory authorities like FDA, EMA or MHRA assist the implementation of RMM, e.g. with documents like USP chapter <1223> or EP chapter 5.1.6.

This two day conference offers you a unique possibility to evaluate the new developments in RMMs as well as the experiences in validation and implementation of the new methods. Furthermore you will hear about the regulatory view in Europe and USA.

Here you can download the brochure in PDF format.