Supplier Perspective: Container/Closure and Device Components in the World of Extractables/Leachables Testing

This manuscript will be given from the viewpoint of a current component supplier to both the OINDP and injectable pharma industries. The manuscript will include a history of challenges and responses to the extractables and leachables trends and issues in Industry from a supplier perspective and provide some case studies that demonstrate how suppliers and pharma can work together can address this issue. These case studies help build the technical and analytical knowledge base and are presented in an effort to assist Industry to more effectively design extractables and leachables analyses in a scientifically sound manner. One example will discuss how a leachable formation impacted the pH of a product. Another will discuss the need for leachables testing for lyophilized product, and lastly, highlights from a market recall situation where extractables and leachables was the main reason for that recall.