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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.
Globally, the market for biologic drugs is growing significantly, due to their proven ability to treat major chronic diseases, in particular those found among an increasingly aging population. Cartridge systems are very important in delivering these biologic drugs; they can be used in autoinjectors, pen injectors, and wearable devices. Since biologics drugs are very sensitive, they require highest-quality cartridge components.
The manufacture of polymer containers for parenteral drug products differs from that of glass and elastomers and must combine the common manufacturing methods below to meet the needs of the pharmaceutical market.
On March 26, the Delaware Valley Chapter of PDA and West Pharmaceutical Services, Inc. co-sponsored a workshop: Defining a Strategy for Combination Products, at West’s headquarters in Exton, PA. More than 150 people from 45 companies that provide drug products and combination products attended. In prior PDA events, combination product regulatory challenges have been cited often as an area both of interest and confusion. This workshop aimed to address them.
One of the challenges a drug manufacturer faces is controlling the drug product at the point-of-use in a hospital or clinical environment. Often the method of vial access is variable, leading to an increased risk of harmful patient outcomes such as stopper cores or fragments entering into the drug product, which can contribute to cardiovascular events. There are a number of causes that contribute to stopper coring and fragmentation in the field that depend primarily on the technique of the practitioner and the properties of the elastomeric closure.
<span style="color: #333333;">Today, we are more connected than ever before. We rely on the Internet to stay informed and to perform our day-to-day jobs. It’s hard to imagine our lives without the Internet; yet for all of its advantages, increased connectivity brings increased risks for cybercrime. Recognizing the importance of cyber security, President Obama designated October as National Cyber Security Awareness Month (NCSAM), as has the European Network and Information Security Agency (ENISA). At West, we are committed to ensuring the ongoing success of our business processes and operations, which requires information that is accurate, complete, consistent and, above all, secure. This makes cyber security one of West’s most important priorities.</span>