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As the pharmaceutical industry evolves amidst changing patient needs, growing regulatory requirements and improved process understanding, West is moving forward with product improvements of its own. In addition to our continuous process and product improvements and optimizations, West is harmonizing its steam sterilizable ready-to-use (RU) product packaging material.
In an effort to provide cleaner and more robust parental packaging components, while continuing to use the same medical grade Tyvek® and polyethylene (PE) film layer components, West announced that it will transition from using a traditional STERIlizableBAGTM to an Enhanced STERIlizableBAG. The Enhanced bag offers a lower particulate specification limit, ensuring a lower particulate packaging option compared to the STERIlizableBAG. The package configuration has also been modified to improve product handling.
All newly developed steam-sterilized Westar® RU products will now use the Enhanced STERIlizableBAG. Use of the Enhanced STERIlizableBAG began December 3, 2012. Customers purchasing Westar RU steam products prior to that time will continue to receive the products within the traditional STERIlizableBAG format. For any questions and inquiries please email Simon.Cote@westpharma.com or TCS.Americas@westpharma.com.
STERIlizableBAGTM and Westar® are trademarks or registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Tyvek® is a registered trademark of E. I. du Pont de Nemours and Company
It is an exciting time to be in the Cell and Gene therapy industry. The astounding growth and development we have witnessed in the cell & gene therapy industry over the last decade is bringing life-changing therapies to the patients who have been so anxiously awaiting them. <br /><br />At the same time, as with any new drug class, challenges that may not have been considered during the drug development phase may suddenly show up and stand in the way of overcoming that last hurdle: Packaging and delivering your precious new molecule to the patient.
Our team will share their expertise and introduce several new and innovative pharmaceutical containment and closure offerings during the Paris Pharmapack trade show.
The pharmaceutical and biotech industries face many challenges when selecting the appropriate stopper, seal, and vial combination for a drug product. Further compounding these challenges is the manufacturing capability of each component supplier. Lot to lot variation can result in components that had maintained container closure integrity (CCI) and visual acceptance during development unexpectedly failing during production. Therefore, it is important to take a system approach when selecting vial container closure system (CCS) components and designing a fill-finish process. To minimize the risk for sterility failure and maximize performance, it is essential to understand not just the process, but also the historical and trending performance of the selected parenteral packaging components. As a result, West has built the DeltaCube™ Modeling Platform to facilitate data-driven selection and optimization of vial CCS components.
<p>Color has a surprising number of uses in injectables packaging.</p><p>European guidance states that “similarity in packaging which contributes to medication error can be reduced by the judicious use of color on the pack” ¹. Draft guidance issued by the U.S Food and Drug Administration (FDA)² similarly recommends that “sponsors use color prudently to bring attention to the product name, strength, and important warning(s).” Color – when applied thoughtfully and with full awareness of the context in which the drug will be used – can be an important way for manufacturers to help practitioners and patients differentiate products and support their correct use.</p>
Mobile technology can be a great time saver, or a time-sink, depending on the apps you’re using and how you use them. At West, we recognize that it’s important to choose your apps wisely. As we begin to build our Mobile App Store, we are focused on applications that enable us to be more connected and forward-looking – foundations for being successful in a globally competitive world. Since there’s an app for almost every purpose these days, we believe that it’s critical to reduce distraction by focusing on apps that will improve productivity wherever our work takes us.
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