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Pharmaceutical and healthcare companies around the world rely on the expertise of West's contract manufacturing team—formerly known as The Tech Group to create innovative, safe and effective drug delivery systems that bring important therapies to patients. For those companies – like ours – quality and innovation are of the utmost importance.
In part one of our video series West on the Road – Tempe, we look at how West's contract manufacturing Rockford campus in Tempe, Arizona is developing advanced automation systems and programs to ensure the quality and efficacy of drug delivery and monitoring systems. This begins by establishing manufacturing processes based on a deep understanding of the customer’s needs and the products themselves. West's contract manufacturing engineers at the 96,500-square-foot facility learn our customer’s products inside and out. They combine that insight with their deep knowledge of medical devices and materials, such as plastics, as well as the latest in insert and multi-shot molding techniques to ensure we’re meeting the needs of our pharmaceutical partners and the patients relying on them.
While the medical manufacturing industry today may be complex as ever, Director of Operations, Mike Moran, believes that manufacturing processes will only grow in complexity in the coming years as a changing healthcare environment—one that is ever more patient-centric—will continue to demand more of the pharmaceutical industry and their manufacturing partners.
Ultimately, people at the contract manufacturing plant understand the critical role that they play in bringing drug delivery systems from concept to patient and delivering the high quality that our pharmaceutical customers – and patients – demand.
West’s Andy Polywacz, VP Quality & Regulatory Affairs, and Jennifer Riter, Sr. Director, Global Analytical Services, will present at the 2015 Interphex conference on April 21-22, 2015. The conference will be held at the Javits Center, New York City, NY.
A new regulatory guidance in the US has clarified expectations for pharmaceutical companies wishing to transition from an existing pharmaceutical component wash process to another, such as the Westar<sup>®</sup> Ready-to-Sterilize (RS) process.
Join West’s Diane Paskiet at the 2013 PDA/FDA Container Closure Components and Systems Workshop:<em>Protecting Parenteral Drugs and Biologics Using Suitable Container Closure Systems,</em> on May 14-15, 2013, at the Hyatt Regency Bethesda in Bethesda, Maryland.
Parenteral drug products must be stored in a container system that provides good container closure integrity (CCI) over shelf life for the purpose of preventing environmental contamination. This system typically comprises a glass vial, elastomer stopper, and an aluminum seal. USP Chapter <1207> <em>Packaging Integrity Evaluation – Sterile Products</em> discusses in detail methods to measure CCI to determine if the system can meet the maximum allowable leak limit (MALL) for its specific drug product (i.e., the smallest gap, or leak rate, that places quality at risk). Critical to achieving good CCI is proper capping of the vial with the stopper and seal, making sure that the compression level of the stopper is appropriate.
Cartridge-based administration using injection device systems has dominated the insulin market for many years. In 2011, the insulin market for cartridge-based container closure systems was at an estimated 1 billion units. Additional applications for cartridge-based container systems include dental, at more than 450 million units per year, and therapies such as human growth hormone, interferon and epinephrine. In fact, thanks to lower production costs when compared to vial and syringe systems, cartridge-based delivery has found a widespread and growing market.