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:
- Pre-Planning and Component Selection
- Gap Assessment and Evaluation
- Risk Assessment
- Leachables Evaluation
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.