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For the tenth consecutive year, teams from West Pharmaceutical Services are raising funds to support research at Fox Chase Cancer Center in Philadelphia. With the support of our families, friends and neighbors, the West team has raised nearly $1 million for Fox Chase since 2004.
For injectable drug products, coring and fragmentation of elastomer stoppers is a critical concern. This is caused by tearing or shearing a fragment of the stopper in a vial during insertion of a needle or a spike. The cores/fragments that enter the drug product may lead to harmful patient outcomes. Testing of stoppers is a must for many pharmacopeias. Coring and fragmentation is complex and influenced by many factors, in particular the stopper and the needle.
One of the challenges a drug manufacturer faces is controlling the drug product at the point-of-use in a hospital or clinical environment. Often the method of vial access is variable, leading to an increased risk of harmful patient outcomes such as stopper cores or fragments entering into the drug product, which can contribute to cardiovascular events. There are a number of causes that contribute to stopper coring and fragmentation in the field that depend primarily on the technique of the practitioner and the properties of the elastomeric closure.
Do you want to better understand how to navigate the regulatory pathway to successfully bring a drug/device combination product (CP) to market? Understanding that many have this question, West, in collaboration with the Delaware Valley Chapter of PDA, sponsored the symposium (Sep 23): <em>The Evolving Landscape for Combination Products – Defining a Regulatory Strategy</em>. Experts from the industry and the FDA presented and discussed the latest best practices.
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