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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.
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?”
Drug products such as biologics, vaccines and products whose chemical and physio-chemical stability depends on temperature put an added emphasis on pharmaceutical manufacturers to ensure proper handling, storage, transportation and dispensing. Maintaining a secure “cold chain” during the storage, handling and transportation of temperature-sensitive drugs, vaccines and blood products not only assures product quality and integrity for the benefit of the patient, but also helps to keep the manufacturer, hospital, pharmacist, physician and nurse in compliance with various laws, regulations, guidelines and codes.
Put on your mask and suit up as Production Manager, Adam Wrench takes us inside <a href="https://youtu.be/pP7uaialLb0"><span style="text-decoration: underline;">West’s Jersey Shore plant</span></a>. Despite the familiar name, there’s no beach or boardwalk here. Rather, Jersey Shore is a town nestled Pennsylvania’s Allegheny foothills. At this plant, employees create numerous West components, including FluroTec<sup>® </sup>and Teflon<sup>®</sup> laminated 13- and 20mm stoppers. It’s the only West facility that includes two steam sterilizers for Westar<sup>® </sup>RU sterile ready-to-use components.
<span style="color: #000000;">West has completed a preliminary study of its SmartDose® technology platform, which incorporates a Daikyo Crystal Zenith® (CZ) cartridge. The study evaluated multiple attributes of the technology and subjects’ experience with the self-application process. </span>
It is essential to consider lifecycle management during the development of new drugs – especially in the evolving area of biologic drugs. The market demand for both ease of use, and patient-centric at-home administration, is driving the need for innovative container systems and delivery devices. Typically, drugs are launched in vials; continuous development often then enables launch in other formats, such as pre-filled syringes and cartridges. West is committed to easing this movement from container systems to delivery devices through its NovaPure<sup>®</sup> component portfolio of elastomer closures. NovaPure stoppers and plungers offer best performance and highest quality. Developed with Quality-by-Design principles, they use FluroTec<sup>®</sup> barrier film and B2 coating technologies.
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