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| home > pmps > spring 2002 > containment of potent compounds - the approach of a manufacturer of automatic filling machinery to aseptic processing |
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 PUBLICATIONS |
Pharmaceutical Manufacturing and Packing Sourcer
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There is an increasing trend for the pharmaceutical industry to use isolator technology coupled with automatic filling systems in order to minimise direct human contact with the process. The improved product handling conferred by such systems means that the risk of microbiological and particulate contamination is reduced, thus enhancing the assurance of product sterility, and potentially protecting the operator from toxic or hazardous compounds.
So how does a manufacturer of automatic filling machines approach product handling under aseptic conditions? Below are two definitions that can lead to a better comprehension of the matter.
Containment is necessary to achieve a validated level of control of a potent substance in order to provide protection for people and the environment (level of exposure) Isolation is necessary to protect the product from contamination from the environment by particulates, chemicals and micro-organisms
From an engineering point of view, containment is the application of design solutions to prevent uncontrolled escapes of highly potent or toxic compounds from a defined area, while isolation can be defined as the application of engineering solutions to prevent contamination or degradation of clean or aseptic materials and processes.
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