Introduction
When talking today about solid dosage form production, in 9 out of 10 cases containment immediately becomes one of the issues. Why? The first reason is that APIs are becoming more and more potent. According to an estimation by ISPE (Winter Conference Berlin 2002), by 2010 more than 85 % of all NCE will be classified potent (OEL < 10 µg/m³). The second reason is that health and safety authorities all around the world are putting more focus on the protection of operators dealing with these substances. The third reason is that suppliers of various hardware components have developed a huge variety of containment solutions, making it difficult to decide on the optimal solution, even for experienced people.
Before we look at the factors defining the required containment levels, and discussing the possible hardware solutions, some fundamental thoughts about containment need to be covered first.
A NEW article from Dr. Harald Stahl
Dr Harald Stahl is a Senior Pharmaceutical Technologist with GEA Pharma Systems. He worked for three years in the Pharmaceutical Development of Schering AG in Germany, specialising in the aseptic production of pellets. Since 1995, he has worked for GEA Pharma in variou s positions. He is an executive member of the ISPE Containment Community of Practice (CCOP), and has published more than 20 papers on various aspects of solid dosage form production, of which several have a special focus on containment aspects. Dr Stahl holds a Diploma in Physics and a PhD in Chemical Engineering.
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