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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.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.