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West authors Diane Paskiet, Kim Miller, Laura Stubbs and Diego Zurbriggen contributed to several chapters in the new “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products” available from Wiley Scientific.
The Handbook offers a practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products, including metered dose inhalers, dry powder inhalers and nasal spray. Such products pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. The Handbook offers a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry.
Chapters where West authors contributed include:
For more information or to purchase a copy of the Handbook, visit: http://www.wiley.com/WileyCDA/WileyTitle/productCd-0470173653.html
On December 1, 2013, the United States Pharmacopeia (USP) General Chapter <1> Injections<em>, </em>Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010) revised standard will become effective. The revised chapter affects all injectable drug products, human and veterinary, intended for sale in the United States.
The U.S. Food and Drug Administration recently issued a draft guidance, <a href="http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM346181.pdf"><span style="text-decoration: underline;">“Glass Syringes for Delivering Drug and Biological Products: Technical Recommendations to Supplement International Organization for Standardization (ISO) Standard 11040-4 (Draft).” </span></a>The document relates to issues encountered with glass Luer lock syringes when connecting to Luer fittings, including needles, needle-free Luer connectors, adapters and transfer units.
West has recently collaborated with a research team at the University of Washington (UW) led by Professor Shyam Gollakota to develop a wearable device to detect and reverse an opioid overdose.
One of the challenges of sharing technical content is making the material engaging and easily digestible to many different types of learners. It must not only be scientifically accurate, but also needs to capture and keep the attention of the intended audience. The Knowledge Center on West’s website is a valuable repository of written and presented materials, created by the experts who develop and test our products. It is also now home to the Learning Center, a section of the Knowledge Center that shares information on a more introductory level, aimed at new employees or companies that are new to packaging. In an effort to continue enhancing our website content, we are now also starting to add new types of media. In the age of podcasts and vlogs (video blogs), we understand that video and audio are just as helpful (maybe more so!) for people trying to grasp a new concept.
West’s Mike Schaefers and Heike Kofler recently published a chapter entitled, “Primary Packaging Components Elastomeric Closures for Pharmaceutical Applications” to APV Basics <em>Pharmazeutische Packmittel</em> (Elastomeric Pharmaceutical Packaging).
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