Webinar
Striving for Zero Defects: Quality-by-Design Principles for Parenteral Packaging Manufacturing
Explore how Quality-by-Design (QbD) principles — applied across elastomer compound selection, fluoropolymer coating technology, siliconization processes, and state-of-the-art automated inspection — enable parenteral packaging manufacturers to mitigate extractables and leachables, silicone particle generation, and contamination risk in drug products.
Status
Published
Format
Webinar
Language
English
Access
Registration Required
Resource Overview
About this Webinar
As injectable drug pipelines shift toward biologics and large-molecule therapies with heightened sensitivity to extractables and leachables, silicone particles, and subvisible particulate contamination, the demands placed on parenteral packaging manufacturers have intensified significantly. This on-demand webinar — the first session in Datwyler's 2020 "Path to Patient Safety" series — examines how Quality-by-Design (QbD) principles can be systematically applied across the full component manufacturing lifecycle to achieve best-in-class specifications and mitigate drug product contamination risk. Topics covered include the evolution of pharmaceutical elastomers and the role of formulation design in determining extractables and leachables (E/L) profiles; the technical performance of Datwyler's proprietary fluoropolymer spray coating as a barrier solution that eliminates siliconization needs and minimizes particle generation; the impact of silicone viscosity and application quantity on subvisible particle levels; key considerations for pharmaceutical elastomers including formulation stability, CCI, and sterilization effects; and how customer-focused QbD optimization, integrated risk planning, and state-of-the-art automated camera inspection within FirstLine® manufacturing sites drive continuous improvement toward zero-defect delivery.
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