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, and in particular process washing, NovaPure components have substantially lower particle levels than legacy products.
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 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.