In this module, we will dive into the Ph. Eur. world of microbiology, starting with the conventional tests such as the test for sterility, the chapters for microbial examination of non-sterile products and the mycoplasma chapter. We will then cover the field of rapid microbiological methods and how their use is promoted in the Ph. Eur.
The second part of the module will be devoted to pyrogenicity testing and the phasing out of the rabbit pyrogen test. We will update you on where the Ph. Eur. is heading and focus on animal-free tests - the monocyte activation test (MAT), and recombinant factor C (rFC).
Each of these sessions will be followed by a live Q&A session.
Programme (subject to change):
- 13:00-14:00 Microbiology chapters
- 14:00-14:45 Rapid microbiological methods and Mycoplasmas
- 14:45-15:00 Live Q&A
- 15:00-15:15 Break
- 15:15-16:00 Pyrogenicity (BET, rFC, MAT, strategy)
- 16:00-16:15 Live Q&A