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We are pleased to announce that our Scientific Insights Lab team members, Liang Fang and Marissa Rase, received the 2021 Fred Simon Award, and its Chief Scientific Officer, Fran DeGrazio, received the 2021 Edward Smith Packaging Science Award at the 2022 PDA Annual Meeting in Dallas.
The two most common means of sterilizing elastomeric parenteral packaging components are steam autoclave and gamma irradiation processes. When appropriately validated, both processes are very effective at eliminating concerns around microbial contamination of the components used for container closure of sterile liquid, lyophilized or powder drug products. Despite the ability of both methods to reach the required sterilization specifications and requirements, the overall impact that these processes have on the elastomeric component can be quite different.
At West, we are not only committed to helping create a healthier world, but also to being good stewards of a sustainable future. Partnering with Waterways Watch Society (WWS), West Singapore team recently set out on kayaks to participate in waste collection sessions, making a tangible impact on the water environment.
What’s the best strategy to create a holistic syringe-based combination product performance testing program? Start with the fundamentals - FDA Guidance Documents, ISO and USP considerations.
<span>Understanding extractables and leachables (E&L) is an essential element of determining the suitability of a packaging or delivery system for a drug product. Recently, PDA presented an <a href="https://www.youtube.com/watch?v=mol_X2zQeig">interview with Dan Mellon, Ph.D., Pharmacology Toxicology Supervisor at CDER’s Office of New Drugs</a>, discussing FDA’s approach to evaluating E&L information </span>
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