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Ever wondered what West’s cutting-edge product development facilities look like on the inside? Jeff Kyle, Sr. Director New Product Introduction, and Tom McLean, VP Delivery Systems R&D, take you behind the scenes of the Scottsdale, AZ plant.
In addition to exploring new products and custom packaging design, the Scottsdale plant manufactures the Crystal Zenith®Ready-to-Use Insert Needle Syringe System, and the SmartDose® electronic wearable injector. West recently expanded the Scottsdale facility to accommodate customer demand for the SmartDose electronic wearable injector, Kyle explains in this clip, including bringing it up to ISO 7 cleanroom standards. That certification – and the tight layout of the assembly floor – helps employees create the systems more efficiently.
Moving to the lab, Jessica Wentzel, Microbiology Lab Manager, demonstrates the rigorous testing that incoming raw materials and Daikyo Crystal Zenith® cyclic olefin polymer components undergo, from a microorganism and endotoxin standpoint.
As McLean points out, West’s state-of-the-art technology and complex production protocols are put in place for one thing: Enriching patient safety. It’s this element of creating pharmaceutical integrated containment and delivery systems for injectable medicines that inspires pride among West employees.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd. Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
SmartDose® is a registered trademark of Medimop Medical Projects Ltd., a subsidiary of West Pharmaceutical Services, Inc. West seeks partners for its SmartDose® injector technology platform. This platform is intended to be used as an integrated system with drug filling and final assembly completed by the pharmaceutical/biotechnology company.
<p style="margin: 0in 0in 10pt;">The new regulation “Bundling Review and Approval of Packaging and Excipients with Drug Products” announced by the China Federal Drug Administration (CFDA) on August 10, 2016, has generated both interest and concern. While the CFDA has published several related guidelines in an effort to address questions, many still persist. </p>
Putting together a risk assessment for nitrosamines in your final drug product is an extensive undertaking. Many contributing factors need to be considered, such as the drug substance’s manufacturing process, excipients, buffers, water, production equipment and environment, transportation conditions, packaging, and more. Within this scope, primary packaging components, such as elastomeric closures, also could contribute nitrosamines or precursors.
Dr. Bettine Boltres
Principal Scientific Affairs, Packaging & Delivery Systems
West is proud to announce that its 2018 Corporate Responsibility Report has been published and is now live on the West website. This report provides a summary of West’s efforts in six key areas including Compliance and Ethics, Philanthropy, Diversity, Health and Safety, Environmental Sustainability and Quality. Below is Part One of a blog series where we look a bit closer at each of our focus areas in the Report, beginning with our commitment to Environmental Sustainability.
Coring, fragmentation, and stopper push-in are some of the common issues associated with rubber stoppers used with transfer devices (e.g., vial adapters). This is because they are punctured with spikes, which are significantly larger in diameter than needles, and are made from plastic materials.
According to the Code of Federal Regulations Title 21 Food and Drugs Part 211.94(a) Subpart E Control of Components and Drug Product Containers and Closures, drug containers must not react or add to a drug product in a way that alters the drug’s safety or quality.