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Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components
The visual inspection of injectable drug product has been a regulatory requirement since 19361, however, successful implementation of the standard has been challenging for many organizations. The number of recall notices issued by the U.S. Food and Drug Administration (FDA) from 2010 through 2019 for injectable products due to visible particulate have reduced since 2014 but at the current trend, will be some time before it approaches zero2. Between 2009 and 2019, the presence of visible particles in parenteral product was the second leading cause for product recalls.3 Patient safety is the main driver for requiring injectable products to meet the criteria of “essentially free of visible particulates.”4
Selecting a container closure system (CCS) is an important part of the pharmaceutical commercialization process. It is important to ensure that the components selected are compatible with the drug product to be packaged; however, it is equally important to ensure that the components are compatible with each other. Here we provide background on the importance of correct pairing between vials and stoppers and showcase lyophilization stoppers V-50-I (13mm) and S-87-I (20mm) in the 4040/40 Gray formulation that can be paired with any vial blowback geometry.
We are pleased to share that West has received the Distinction Award of the AmCham Singapore CARES initiative, which is a further testament to West’s continued commitment as a good corporate citizen and our contributions on making a positive impact in the communities we serve.
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.