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An increasing number of new chemical entities leaving the development labs is deemed to be toxic. According the author’s observation the projects erected for those projects are following conventional design principles. It might be worthwhile to investigate dedicated and thus novel solutions.
The author restricts his paper to production plants for solid forms and excludes development facilities.
In the first chapter the regulatory situation is highlighted. In contrast to the GMP-rules no internationally harmonised definition of exposure levels can be seen. Whether dilution might be a solution to reduce the operators risks is another question to be raised.
The next chapters deal with technical measures to cope with highly potent substances in API-plants as well as in formulation.
A separate chapter is dedicated to the galenical development of potent drugs. The author’s opinion is that development labs should pay more attention to toxicity aspects.
Furthermore the question is raised, whether automation might be a means to reduce exposition of operators. In the following chapter „PAT“ and it’s role in potent drug facilities is highlighted.
A request for further integration of production steps e.g. tabletting at the end of API-production is terminating the number of novel approaches to cope with potent drugs. The well established ones might not be the right direction to a successful project.