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In October 2017, PDA (Parenteral Drug Association), held a joint workshop with PQRI (Product Quality Research Institute) entitled: Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop.
Industry and regulatory experts addressed best practices and obtained fresh technical information in order to bring clarity and direction around the risks and challenges of packaging and delivery systems – with an ultimate focus on combination products. Key points addressed included particulates, biocompatibility, leachables/extractables, biologic stability, and container closure integrity. The meeting opened with a plenary session, The Future of Drug Delivery by Didier Pertuy, Vice President and Global Head of Drug Device Integrated Development and Device Strategy, Sanofi. Other sessions were:
A summary can be found here.
Patient safety is defined by the Institute of Medicine as: the prevention of harm to patients.<sup>1</sup> The extension of this principle to general safety in healthcare is: the freedom from accidental injury, and it applies not only to patients, but to all professionals and workers in the healthcare field.<sup>2</sup>
On July 3, 2013, Novartis issued a <span style="color: #0000ff;">voluntary recall</span> of its Menveo<sup>®</sup> vaccine. Menveo is a lyophilized meningococcal vaccine used against <em>Neisseria meningitidis</em>, a bacterium that causes meningitis, meningococcemia and septicemia, and rarely, carditis, septic arthritis or pneumonia.
Following her mom’s Parkinson’s diagnosis, Caitlin Joran, Specialist, Global Communications, Exton, made it her mission to learn everything she could and fundraise to support local families.
Selecting the best vial container closure system (CCS) components and capping process for a drug product ensures optimal performance and patient safety. An optimized CCS requires compatible components (rubber stopper, aluminum seal, glass or polymer vial) and proper capping setup. This provides predictable sealing performance, which maintains the container closure integrity (CCI) needed for patient safety and visual acceptance.
Cell therapies offer a powerful new approach to treat cancer and other serious conditions. The manufacture and supply of these therapies is complex – to address the short shelf lives of such living products, storage and shipping is done at cryogenic temperatures (liquid nitrogen, approximately -180<sup>o</sup>C). A challenge is selecting the right container system.<br />
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