Connect Conference & Show Floor Educational Sessions

View, browse and sort the list of Connect Conference sessions and show floor programming by pass type, track, and format. Please note, all Connect Conference delegates have access to InformEx Connect and CPhI Connect programming. Seating is first come, first serve, so please arrive early to sessions that you would like to attend. Sessions are subject to change.

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  • Suitability of Packaging Materials and Systems for Therapeutic Products: USP Standards Update - Powered by United States Pharmacopeia

    Location:  112AB
    Track: Drug Manufacturing
    Pass Type: Connect Delegate, VIP Attendee - Get your pass now!
    Vault Recording: TBD

    Plastic and elastomeric packaging materials are used in a variety of ways within the pharmaceutical sector, from packaging system and medical devices to tubing and single use components used in the manufacturing process.

    The question faced by the pharmaceutical industry is, "What ultimate impact does a plastic or elastomeric material or component has on the drug product?" Because the makeup of most packaging materials is proprietary, end-users must rely on their own testing for extractables and leachables to determine a material suitable. With a robust Compendial standard, knowledge of a material can be obtained that will provide the end-user with the ability to make more informed decisions about materials during the drug development process, which ultimately saves time and effort. Improvements in analytical techniques and industry best practices has made USP take a closer look at it current standards associated with plastic and elastomeric materials used to package pharmaceutical products and the biocompatibility testing of these materials. This conscious review of these Compendial Standards has led to efforts to update them.

    Thus, the session will give an overview of USP's current efforts to revise <87> Biological Reactivity, In Vitro, <88> Biological Reactivity, In Vivo, <381> Elastomeric Closure for Injection and the suite of Plastic Packaging Standards (<661>, <661.1>, <661.2>). This overview will include the rationale and current thinking behind revisions and timeline. Recent revision has stimulated a lot of discussion and feedback from various USP stakeholder and will discuss how this feedback will impact revision efforts moving forward.