Sanitization and Biofilm

Microbial growth in water generation, storage and distribution systems should be controlled as much as possible and reasonable for the application. Effective microbial-control strategies typically include multiple approaches, considering design features and sanitization activities in several different locations of the pharmaceutical water system.These are intended to work together to achieve a high level of control over the microbial proliferation within a pharmaceutical water system. These strategies have to be applied locally to individual unit operations or points of use.  Also a more broadly application to the whole system , such as the entire storage and distribution system or the generation system is also necessary. Their collective success is related to their individual effectiveness and should be subject to thorough review processes too. In the training we will discuss various sanitization concepts and why these are necessary to avoid biofilms. We will also have a brief overview on biofilms and some examples of biofilms contaminations.

Speaker


Stephan Neumann has a M.Sc. In Utility Engineering and is pursuing a M.Sc. in Pharmaceutical Microbiology. He works for Boehringer Ingelheim since 2002 and his role is " Global Governance Pharmaceutical Water Systems". He is providing support to all production sites in the network. This encompases hands-on site support, audit (response) support, troubleshooting, training, site improvements and much more. He is a member of the ISPE D/A/CH Critical Utilities group. He did contribute to the ISPE Handbook "Production of Water for Injection without Distillation", which goes into multiple ways to produce WFI acc. to European regulations. Stephan is also a member of the EDQM Water Group. This group is responsible for the water monographies in the European Union.

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