Containing Potent Pharmaceutical Powders - A Strategy Guide

By Mina Ibrahim, P.Eng., MBA

With the rise in popularity of High Potency Active Pharmaceutical Ingredients (HPAPIs) there has come increased interest in the containment and safe manufacture of such cs. As drugs become more potent, they become increasingly dangerous to the health of plant personnel and manufacturers face significant challenges in ensuring the protection of their workers. This paper will present the strategies employed to properly contain pharmaceutical solid powders of various potency levels. Focus will be on containment methods used to protect employees who have to enter the local manufacturing room. A containment strategy selection procedure will  also be presented. Comprehensive discussion of the different strategies outlined in this paper  can be found in the book Containment  Systems  —  A  Design Guide by Hirst, Brocklebank, and Ryder, which covers in more detail the methods of containing toxic powders and liquids.

There are two main goals in the containment of pharmaceutical drugs:  The first being the protection of workers who are coming into proximity with the product and the second being the avoidance of product contamination. This second goal includes protecting the drug from environmental factors (such as dust, excess moisture, airborne pathogens, etc) and from contact with other drugs that may be manufactured in the  same  facility, an appropriate  containment  strategy  protects  the external environment (everything outside the containment barrier) from the drug and the drug from the external environment.