Hardware Podcasts

153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio

Let's Combinate · 11 Sept 2024 · 21m

What this episode covers

Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and former Chief Scientific Officer at West Pharmaceuticals, explains the transition from USP <381> to USP <382>, which shifts the focus from isolated component testing to evaluating elastomeric closures as part of a functional system. She details how sterilization processes like steam and gamma radiation impact rubber integrity and why pharmaceutical sponsors must now generate system-level data to ensure compliance by the December 2025 effective date. Degrazio also discusses the importance of harmonizing with ISO standards and addressing functional challenges such as spike penetration and push-in in vial, syringe, and IV bag systems.

Most relevant to

established companies

Topics

Mentioned

Companies
West Pharmaceuticals, Strategic Parenteral Solutions, FDA
Also
USP <381>, USP <382>, USP <1382>, ISO

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