PDA Research: 2020 Particulate Matter in Flexible Containers Survey (single user digital version)

Mar 2021
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The 2020 PDA Research Particulate Matter in Flexible Containers Survey was undertaken to address the industry-wide concern raised by multiple recalls for particulate matter in flexible container and other container products dating back to 2012.

This survey was conducted to establish a benchmark of current industry practices in the area of visual inspection of injectable products with emphasis on flexible container closure systems. It is intended to obtain more details specific to the role of visual inspection as it pertains to the wide variety of flexible container closure systems.

Questions on current practices for manual, semi-automated, and automated inspection, along with aspects of qualification, were included. Other process-related elements, such as component inspection and the use of sampling for acceptance, were queried to gain further insight.

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Table of Contents

Table of Contents:

Visual Inspection Processes
Acceptance Quality Limit Inspection Processes
Sampling for Batch Release
Inspectors and Qualification
Component Inspection