Controlling Particle Load in NovaPure® Elastomer Components
Particles in parenteral drug products have been a major source of product recalls in recent years (>100 from 2010-16). They are especially problematic for biologic drug products, where they can induce formation of protein particulates that may have immunogenic effects.
At the 2nd PDA Particles in Injectables Conference (Berlin, GE – September 27-28, 2017), Dr. Bettine Boltres, Technical Account Manager in Technical Customer Support (TCS), presented on West’s approach to the issue for elastomer components: Controlling Particle Load in NovaPure® Elastomer Components. Click here to view the science poster in our Particles section of the Knowledge Center.
The first step is an Ishakawa-type cause/effect analysis of the factors that can affect particle loads: materials, equipment, process, people, methods, release/receipt. Understanding these factors, the second step is using Quality-by-Design (QbD) principles to establish a Quality Target Product Profile (QTTP) with low particle (visible and subvisible) levels. By rigorously controlling the factors mentioned, NovaPure components represent the highest levels of particulate risk mitigation across different formulations.
West confirms this – all NovaPure products undergo the West Envision™ automated vision verification inspection process. West is committed to safe and efficient delivery of drug products to patients. NovaPure components, with low particle levels and supplied washed or ready-to-use (sterile), are a key part of that commitment.
NovaPure® and Envision™ are trademarks or a registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.