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The presentation addressed three major issues: source, control and measurement. Particles represent a very serious risk to patient safety – especially those from external sources, where bioburden is uncontrolled. Sources of particles are many: materials, equipment, processes, people, methods, and release/receipt. The best way to understand the sources, and be in the best position to exercise control over these sources, is through an Ishakawa cause-and-effect analysis – identifying and understanding the influence of all possible factors. Critical as well is the measurement of particles: number, size and composition. However, the challenge is the execution of measurement – which requires considerable insight and laboratory expertise. Identification requires different methods. And like identifying sources of particles, a cause-and-effect analysis must be done to understand factors (e.g., equipment, preparation) that affect limits of uncertainty in measurement.
Particles in parenteral drug products will always pose a risk to patient safety. Better measurement ultimately leads to better understanding of the source, and a better ability to control. West’s aim is to be at the forefront in developing more effective methods to measure particles, with the goal that is always in mind – patient safety. To read Fran DeGrazio's full presentation, visit the Knowledge Center.