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

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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.

Particulate risk in parenteral packaging falls into three categories — inherent (from the component), intrinsic (from manufacturing), and extrinsic (from the environment) — each requiring a distinct prevention and corrective strategy.
The analytical test method landscape for particulate matter spans ISO 8871-3, USP <787>/<788>/<789>, USP <790>, and AQL per ISO 2859, each with different detection limits and capabilities; results from different methods on the same batch can vary significantly, and the absence of visible particles does not guarantee the absence of subvisible particles.
Datwyler's contamination lifecycle framework links QC release data and out-of-trend ISO 8871-3 results to IR source library identification and root-cause analysis, enabling structured continuous improvement projects that progressively reduce particulate exposure in injectable drug packaging programs.

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