WIT Press

Handling Of High Potency Drugs: Process And Containment


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WIT Press


G. Mari, A. Moccaldi & G. Ludovisi


Modern process plant design and the issue of containment will be discussed in this paper. This topic is particularly important when handling dangerous (or active) substances in powder form. The kinds of techniques presented are mainly applied in the pharmaceutical and nuclear industries. This paper will examine issues in high potency powder containment, particularly the concepts of containment, permanent physical barriers between product and operator, negative pressure isolator containment to ensure safety in the event of glove malfunction or accidental door opening and isolator chamber cleaning systems. The various types of isolators, from a simple single chamber to more complex double chamber systems or special connection systems such as external boxes for material ingress/egress, will be described. Also the uses of isolators throughout an entire production plant will be discussed from dispensing operations, through reactor loading and centrifuge unloading, to final product unloading from the drier. Keywords: containment, isolator, glove box, safety, industrial hygiene, pharmaceutical, nuclear. 1 Introduction In the recent years, the Pharmaceutical Industry has developed new and more potent Active Ingredients, particularly in the field of cytotoxics for oncologic use. At the same time, companies are paying increased attention to problems of Safety, Industrial Hygiene and the Environment. As is well known, these kinds of problems can also bring undesired consequences many years after the production campaign. This usually requires companies to pay very high


containment, isolator, glove box, safety, industrial hygiene, pharmaceutical, nuclear.