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<p><em>West is pleased to welcome guest blogger Dr. Marla Phillips, Director</em><em>, Xavier University.</em></p><p>Materials and products used to serve the drug and device industries are supplied from areas all over the world. From raw materials such as sand to highly processed components for delivery systems, the materials that are used to create packaging systems are presumed to be safe. But how can pharmaceutical manufacturers be sure that incoming materials used in these products are consistently safe and reliable?</p>
Liquid injectable drugs can be contained in a pre-filled syringe system, a cartridge-based system, or a vial-based system (with a rubber stopper and seal). For a vial-based system, the drugs first are aseptically filled into glass or polymer vials. During the subsequent Fill & Finish operations, the vials are closed temporarily by inserting a rubber stopper into the vial orifice. This is prior to crimping with an aluminum seal, which results in the final integral vial-based container closure system.
For 10 years, West has offered a summer internship in many of its U.S. locations. The Ambassador Internship Program has grown from hiring two interns in its first year to hiring 38 interns in 2018. <br />
The FDA has approved over twenty (20) cell and gene therapy drugs, and with the rapid growth of the cell and gene therapy market, there is greater demand than ever to demonstrate container-closure integrity (CCI) at ultra-low temperatures. To preserve the product’s efficacy, most cell and gene therapy drugs are stored at temperatures below -60ºC. Many of these products are packaged in either vial systems or cryogenic freezing bags. While each of these container-closure systems poses a unique challenge for the evaluation of CCI at ultra-low temperatures, the discussion in this blog focuses specifically on vial systems.
On March 25, 2017, West team members participated in the Girls Exploring Tomorrow’s Technology (GETT) Expo, a STEM career exploration event for girls in Grades 5 - 10. West sponsored the event which took place at West Chester East High School in West Chester, Pennsylvania. Employees representing a variety of functions within the business helped to staff the booth.<br />
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