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This old joke may evoke a laugh but when it comes to the issue of particulate as it relates to drug products, reducing the risk of contamination to patients is the number one concern of drug manufacturers. People, equipment, materials and the environment can all contribute to the presence of foreign matter in drug products and their packaging components. Drug manufacturers and the regulatory agencies have raised their expectations around particulate and are demanding that supplier partners, like West, develop products and processes to achieve zero-particulate levels.
West has adopted continuous improvement measures to align with the growing demands around quality. The FDA is now recommending that Quality by Design (QbD) be the standard used during the evaluation of prefillable syringe container closure systems. Quality by Design is a model that demands a higher level of performance with minimal variability for packaging components. West’s NovaPure® components are the result of processes built around QbD principles. As it relates to the particulate issue, NovaPure components offer the tightest particle specifications. NovaPure components are also the first offering from West that specifies both sub-visible and visible particle control. NovaPure components contain the same Flurotec® barrier film as other West components, which aids in reducing particle adhesion; however, the profile for NovaPure components is enhanced with regard to process inspection, controls and release specifications.
Moving forward, customers will continue to challenge West and other suppliers to achieve a zero-particulate standard. Closing the gap between this standard and the current technology will be a critical focus of West. This ongoing investment in high-quality components will help ensure patients receive drug products that are both safe and efficacious.