Barrier Isolation Technology: A Labor-Efficient Alternative to Cleanrooms

Abstract

Barrier isolation technology has been recognized by the Food and Drug Administration for a number of years as a safe and effective way to process parenteral products aseptically. Pharmaceutical companies have shown that this method of processing increases the sterility assurance level of their products and reduces manufacturing costs. Hospital pharmacies in Europe have used this technology for more than 10 years as a means of product and personnel protection. In the United States, the technology is becoming accepted because of its capital cost effectiveness and because it increases safety during the preparation of cytotoxic compounds. Some pharmacists, however, have expressed concerns about the efficiency of such systems in the pharmacy setting. Using work measurement techniques, the authors tested a barrier isolator system at the University of Cincinnati Hospital. The results are presented here.