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West is proud to announce that we have published our 2021 Corporate Responsibility (CR) Report, Purpose. Driven., which is now available on West’s website.
This is West’s 6th annual CR Report, and highlights ESG successes from over the past year, including progress on environmental sustainability goals, diversity and inclusion, and success around the Company’s philanthropic efforts. The publication also highlights some of the recognition received for our ESG (Environmental, Social, Governance) performance, including placement in Barron’s Top 100 Most Sustainable Companies, Corporate Social Responsibility Programme of the Year from Pharma Industry Awards in Ireland, and a Silver Stevie Award for Corporate Social Responsibility.
Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components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.