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Pharmaceutical industry focus on issues of extractables and leachables from packaging/delivery systems began during the mid-1990’s. Since then, regulatory agencies have become more educated, and drug product formulations have become more complex, which makes the need for a robust extractables and leachables program that much more critical. 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 question is – where to start?
To assist customers in developing a comprehensive, risk-based approach to the evaluation of extractables and leachables, West has developed the Extractables Data Guide (West EDGe). It is a combination of West’s vast experience and industry guidance, and serves as a roadmap for the evaluation process.
Currently offered for elastomer formulations 4023/50, 4432/50, and 4031/45, the West EDGe guide considers four critical areas:
1. Pre-Planning and Component Selection
2. Gap Assessment and Evaluation
3. Risk Assessment
4. Leachables Evaluation
The analytical data in the West EDGe guide was obtained in West’s GMP laboratory in Exton, PA. To provide a comprehensive evaluation, Westar® Ready-to-Use elastomer products were tested using multiple analytical techniques. The West EDGe guide can be attained by contacting West Technical Customer Support via our Contact Us form.
Additionally, West offers the assistance of its scientific staff for consultation through the evaluation process, and its laboratories for execution of the experimental process. The West EDGe guide, 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 EDGe™ is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
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 />
West is committed to the safe and efficient delivery of drug products to patients. Key to this is not only staying abreast of industry developments, but also being prepared to help customers address them. This is a focus of the Integrated Solutions platform.
Today’s business environment demands a seamless and continual transition of digital experience to conduct business and engage various stakeholders in the same way we conduct the rest of our lives outside work. The experience expectation is consistent across devices of choice from phones to tablets to laptops. That’s why West partners with the world’s top pharmaceutical, biotech, device and diagnostic companies to embrace technology that supports the patients they serve with online resources and tools to better manage their health. In turn, we’re looking to support our customers with digital tools to help speed the research and development process of bringing life-saving medicines to patients that need them.
West’s subject matter experts are out and about this spring with speaking engagements and booths booked at a variety of conferences and trade shows.
For the pharmaceutical industry, the cost of developing new and innovative therapies will continue to rise (the cost of developing a drug is now estimated to be between $1.5 billion to more than $1.8 billion<sup>1</sup>).
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