Cleaning and Decontamination of Potent Compounds in the Pharmaceutical Industry

One of the significant issues encountered when handling potent compounds is the ability to clean contaminated surfaces to a safe and operable level. Such a level, whether driven by good manufacturing practices (GMP) or industrial hygiene (IH) guidelines, can be low enough to be a challenge. In deali...

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Bibliographic Details
Published in:Organic process research & development 1999-01, Vol.3 (1), p.44-52
Main Authors: Valvis, Ioannis I, Champion, William L
Format: Article
Language:English
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Summary:One of the significant issues encountered when handling potent compounds is the ability to clean contaminated surfaces to a safe and operable level. Such a level, whether driven by good manufacturing practices (GMP) or industrial hygiene (IH) guidelines, can be low enough to be a challenge. In dealing with it, emphasis must be placed on (i) establishing meaningful criteria for cleanliness, (ii) formulating a rationale for the design of a cleaning procedure, (iii) developing a deactivation (“kill”) solution, when possible, and (iv) developing a reliable analytical scheme. This paper discusses the above topics in detail as they apply to various operations in the pharmaceutical industry. Furthermore, two cases involving the cleaning of a nondegradable cytotoxic compound following a manufacturing campaign, and the cleaning of an anti-thrombotic compound following a laboratory spill incident, are presented.
ISSN:1083-6160
1520-586X
DOI:10.1021/op980181d