Continuous Improvement in Drug Packaging and Delivery System Cleanrooms: Maintaining patient safety in medical device facilities

摘要

For manufacturers of drug packaging delivery systems -- comprising components, vials, and single-dose syringes all the way to cutting-edge auto-injector systems -- there's much at stake in the cleanroom environment. The patients who are the ultimate end-users trust their health to the quality, sterility, and integrity of the containers and delivery systems, as well as the accuracy of the measured volume of medication within them. Cleanrooms play a crucial role in patient safety. Regulators around the globe are moving drug manufacturers toward continuous improvement with zero defects in mind. With injectable drugs, this specifically can mean limiting particulate levels -- and the manufacturers of drug delivery systems must do their part to meet this challenge.