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West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, has released its 4040 LyoTec® Westar® Select Ready-to-Sterilize (RS) and Ready-to-Use (RU) Lyophilization Stoppers, the first components of a portfolio of vial closures to be developed using West’s new state-of-the art elastomer formulation, 4040/40 gray. By combining the demonstrated success of an established design and significant levels of expertise in testing and raw material selection, we have achieved improvements and optimized benefits across the spectrum of packaging attributes required for performance, quality, and safety of the packaging and delivery of lyophilized drug products.
Nurturing a culture of philanthropy and community involvement is one of the defining characteristics of West. Team members around the world take their responsibility to give back very seriously, donating considerable time and resources to help create a healthier world. West without Borders, our team member-led giving programme, has raised millions of dollars since its inception in 2004 and the initiatives in Ireland were recently recognised at the Pharma Industry Awards for Corporate Social Responsibility Programme of the Year.
NovaPure® Components Overview
By leveraging nearly 100 years of pharmaceutical packaging knowledge and implementing Quality by Design principles, West has developed the continuously improving NovaPure® elastomer portfolio which can be ideal for all drug product phases.
The presence of particulate matter (PM) in parenteral drug products is a well-known challenge for pharmaceutical companies due to the potential quality and safety risks involved. In biotherapeutics, critical attributes related to efficacy, potency, clinical safety, and immunogenicity can be affected by PM.1-3
PM is defined as extraneous mobile undissolved particles (excluding gas bubbles) that are unintentionally present in solutions.4
Several USP chapters describe the measurement of PM, namely: