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Preventing cross contamination of potent compounds – Considerations in a multi-product facility

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PAUL DOHERTY
Ferro Pfanstiehl Laboratories, 1219 Glen, Rock Avenue, Waukegan, IL 60085, USA

Abstract

This article will touch on the philosophy and methods used to prevent cross contamination of a potent compound into other products produced at a multiple product facility. The key to preventing cross contamination of potent compounds into other products is to establish a site policy and system that establishes the administrative and engineering standards, controls and practices for containment of potent compounds. It is important to focus on the entire facility and not just on the production area when preventing cross contamination. An OEL determination or assessment is the foundation of a sound program in order to effectively and efficiently determine the proper engineering controls, administrative controls, policies and procedures and cleaning verifications. Verifying the effectiveness of the containment control strategy by an Industrial Hygiene monitoring of employees is an absolute essential ingredient to ensuring a safe environment for all those involved in the handling of potent or cytotoxic compounds and for verifying that containment measures are adequate for preventing cross contamination.


INTRODUCTION
The market for high potency Active Pharmaceutical Ingredient (API) compounds is growing faster than the API market in general, primarily due to the growth of oncology drugs. Because these APIs are in fact “potent” and a small amount of compound can have a significant pharmacological impact, these compounds frequently are produced in very limited annual volumes. Therefore, it may be economically impractical to dedicate an entire facility to the production of a single potent compound except in cases of unusually high production quantities or in cases of extremely high potency compounds. In most situations, potent compounds are manufactured in a facility in which other compounds are also manufactured. This article outlines the best means to prevent