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The pharmaceutical industry’s focus on extractables and leachables from packaging/delivery systems began during the mid-1990’s. Today’s regulatory agencies are more educated about the process, and drug product formulations have become more complex, which makes the need for robust extractables and leachables programs more critical than ever. In fact, failure to properly evaluate extractables and leachables has had a negative impact on many pharmaceutical companies, e.g., late-stage stability failures, submission delays, and recalls. To avoid this, the first question to ask is – “where do I start?”
To assist customers in developing a comprehensive, risk-based approach to the evaluation of extractables and leachables, West offers its VeriSure™ packages, which are extractables data packages for its highly recommended rubber formulations, 4023/50 and 4432/50. Data were obtained in West’s GMP laboratory in Exton, PA, using multiple analytical techniques to provide a comprehensive evaluation. These data illustrate West’s vast experience with rubber formulations and extractables analysis. Combined with West’s industry experience, as well as other service offerings, VeriSure packages serve as a roadmap for a regulatory submission – enabling customers to move rapidly from extractable studies into simulation and/or leachable studies. Further, West supports customers by designing extractables studies for other formulations and materials, as well as risk assessments for extractables.
West can support customers in four critical areas, offering the assistance of its scientific staff for consultation through the evaluation process, and its laboratories for execution of the experimental process:
The VeriSure packages, along with West’s knowledge in extractables and leachables testing, make West a good choice for customers who must make data-driven decisions on extractables and leachables. West’s VeriSure packages can be attained by contacting West Technical Customer Support via the Contact Us form.
VeriSure is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
West’s Glen Zimmermann, Director, Sales & Marketing, Administration Systems, and Alvaro Estrada, Senior Director, Strategic Program Management and Technical Operations, will present, “Considerations for Integrated Drug Delivery Systems:<em> </em>Exploring new technology and innovation in injectable drug therapy devices”<em> </em>at the ISPE-DVC January Program Meeting on January 15, 2013, from 5:00 p.m. to 8:30 p.m.
Binghuan Cao, Sr. Tech Support, Maintenance, China, has worked at West for 12 years. He is a highly motivated, philanthropic activist for West without Borders activities and local community services. Binghuan has been involved in West Without Borders activities in China for the past 10 years. In addition to donating, he has volunteered as a representative for West in support of local schools and community organizations.
West’s team members in Germany have spent the past month on charitable activities as part of the 2013 West without Borders fundraising initiative. Donations inspired volunteers to prepare lunch, snacks and desserts for their colleagues. Other activities included a raffle, various food sales and a flea market at plants in Eschweiler, Stolberg and the European Headquarters at Kiefernweg to help raise money for local children in need. This year’s motto was “Gemeinsam erfüllen wir Herzenswünsche” (Together we make dreams come true).
On May 30, 2015, West employees in Germany donated their time and manpower to support two local non-profit organizations—<a href="http://www.pferde-staerken-online.de/"><span style="text-decoration: underline;">Kids auf Trab</span></a> and <a href="http://zwischenuns-filzbluete.de/?page_id=371"><span style="text-decoration: underline;">Zwischen Uns e.V.</span></a>—with a community day, held under the patronage of Rudi Bertram, mayor of Eschweiler.
At West, we are committed to safeguarding the health and safety of the millions of patients who use our products every day. This commitment is anchored in our Core Value of Leadership in Quality, which ensures we never compromise on quality because we know that patients are counting on us.
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