Handling Of High Potency Drugs:
Process And Containment
Author(s)
G. Mari, A. Moccaldi & G. Ludovisi
Abstract
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
Keywords
containment, isolator, glove box, safety, industrial hygiene,
pharmaceutical, nuclear.
Related Book
Other papers in this volume
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