Hardware Podcasts

086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with ⁠Fran DeGrazio⁠

Let's Combinate · 24 May 2023 · 30m

What this episode covers

Fran DeGrazio, President & Principal Consultant at Strategic Parenteral Solutions and former Chief Scientific Officer at West Pharmaceuticals, explains the manufacturing and processing of elastomeric stoppers and plungers for injectable drug products. She details the differences between uncoded, coated, and laminated components, the specific challenges of silicone oil migration, and the distinction between compression molding and injection molding for rubber. DeGrazio also clarifies the regulatory landscape, specifically the split of USP <381> into <381> and <382> and the role of ISO standards in global harmonization.

Most relevant to

established companies

Topics

Mentioned

Companies
Strategic Parenteral Solutions, West Pharmaceuticals
Also
USP <381>, USP <382>, ISO 15378, USP <1663>, USP <1664>, EP 3.2.9

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