Sicherer Umgang mit Wirkstoffen in der pharmazeutischen Entwicklung Torsten Wagner, Claus Rau, Stefanie Brätter und Kai Jürgens Schering AG, Berlin Korrespondenz: Dr. Torsten Wagner, Schering AG, 13342 Berlin (Germany), e-mail: torsten.wagner@schering.de Safe Handling of Highly Potent Compounds in the Pharmaceutical Industry Key words Arbeitssicherheitsmaßnahmen • Containment • Mock-up • Occupational Exposure Limit (OEL) • Pharmazeutische Entwicklung • Umgang mit WirkstoffenA pharmaceutical manufacturer is obliged to avoid over exposure of its employees (staff) when dealing with highly potent compounds. Hence a safety concept comprising different safety measures has to be established as a prerequisite for safe handling of highly potent compounds. Initially, acceptance limits have to be determined and compounds are to be classified and assigned to four hazard groups (G1- G4) according to their known pharmacological and toxicological properties. Secondly, process inherent risks are to be evaluated and measures are to be taken to reduce potential risks. Finally, the effectiveness of these measures needs to be assessed. |
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pharmind 2006, Nr. 5, Seite 625