Caprice Hightower

Sr. Technical Acct. Specialist, TCS

May 25, 2017

Unique Considerations for Testing and Understanding Particle Loads for Primary Packaging Components

Particles in parenteral drug products continue to be an important concern. At the April-2017 AAPS Workshop Challenges and Patient Impact of Particles in Biologics, Fran DeGrazio, VP of Scientific Affairs and Technical Services, spoke on the topic: Unique Considerations for Testing and Understanding Particle Loads for Primary Packaging Components.

 Fran DeGrazio

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.