Webinar
Using Quality Principles to Analyze and Quantify Particulate Matter in Parenteral Packaging
This on-demand webinar covers the full particulate matter management lifecycle for parenteral packaging — from QbD-based design and manufacturing controls that prevent contamination, to ISO 8871-3, USP <787>/<788>/<789>, and AQL-based detection methods, to continuous improvement frameworks for trending and root-cause identification.
Status
Published
Format
Webinar
Language
English
Access
Registration Required
Resource Overview
About this Webinar
Injectable drug products must meet stringent visible and subvisible particulate matter standards — yet the analytical methods used to assess compliance span multiple pharmacopoeial frameworks with different capabilities, limitations, and acceptance criteria, making consistent quality management a significant technical challenge. This on-demand webinar — the third and final session in Datwyler's 2020 "Path to Patient Safety" series — provides pharmaceutical quality, manufacturing, and regulatory professionals with a structured framework for managing particulate matter risk across the full parenteral packaging lifecycle. Topics include the classification of particulate risk into inherent, intrinsic, and extrinsic categories; QbD principles applied to component design (compound selection, fluoropolymer coating, siliconization type and quantity), stopper packaging design (PE/EVOH/PE, Tyvek, RTU, RFS, and Rapid Transfer Port configurations), and manufacturing environment controls (Grade C cleanrooms, personnel gowning, and automation); the technical landscape of test methods including ISO 8871-3 visible and subvisible particle testing, USP <787>/<788>/<789>, USP <790>, and AQL per ISO 2859; camera inspection capabilities and detection limits (≥0.05 mm² area, ≥10% contrast ratio); and a continuous improvement lifecycle model using IR source library identification, periodic trending, and contamination-to-root-cause linking to drive ongoing reduction in particulate exposure across manufacturing operations.
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