The West Blog

Latest Blogs

Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components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

John Rech

August 11, 2022

Latest Blogs

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.

Olga Laskina

July 19, 2022

Latest Blogs

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.

Tara Haarlander. M

June 28, 2022

Latest Blogs

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.

Catriona Kennedy

June 23, 2022

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Previous Blogs

Ready-to-Use Steam-Sterilized Westar® and Westar® Select Elastomer Components Simplify the Filling Process

By Daria Miller

February 16, 2021

As customer needs rapidly change to meet these new and unprecedented accelerated timelines, West’s steam-sterilized, ready-to-use Westar^® and Westar^® Select elastomer components play a critical role. They simplify component preparation and allow customers to focus on other aspects of the drug filling process.

Introducing Westar® Select Components

By Grace Knickerbocker

July 23, 2018

As the need for higher quality drug delivery and packaging components increases, customers are challenged to meet new standards and comply with additional regulatory requirements. To help our pharmaceutical and biopharmaceutical partners meet these challenges and reduce risk, West has developed next-generation quality for ready-to-sterilize and ready-to-use components.

Daikyo Crystal Zenith Leur Lock syringes

Benefits of Electron-Beam Sterilization

By Katie Espenshade

February 13, 2018

Electron-beam irradiation (e-beam - sometimes called beta irradiation) is a technique used commonly to sterilize pharmaceutical packaging products and medical devices. It operates by directing a continuous flow of electrons through the articles being sterilized. Transfer of energy from the e-beam breaks the chains of DNA in organisms, rendering them inactive, and the articles irradiated as sterile. It is used typically for Ready-to-Use (RU) vials and syringes comprising Daikyo Crystal Zenith® cyclic olefin polymer, and Daikyo PLASCAP® seal products.

Best Practices in Sterilization of Rubber Articles

By Bjoern Henze

December 05, 2017

Pharmaceutical closures used in aseptic environments must be introduced in a sterile state. The most common methods to sterilize rubber closures (e.g., stoppers) are autoclaving (saturated steam) and gamma irradiation. Both methods can influence chemical (e.g., extractables profile) and physical/functional properties (e.g., break-loose and extrusion forces). Therefore, it is important to choose the right method.

Keeping Patient Safety Paramount Wherever a Drug is Made

By West's Global Communications Team

March 16, 2016

The pharmaceutical supply chain is more complex than ever, with the pricing of critical drugs a subject for hot debate in the media and, most recently, in U.S. Congressional hearings.

Daikyo RSV® and RUV® Components Offer a New Option to Meet Today’s Packaging Needs

By Kristine Davidson

December 08, 2015

There is an increasing trend in the pharmaceutical industry for ready-to-use components for a variety of reasons.