ASTM E3230 PDF
ASTM E3230 PDF
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ASTM E3230 PDF

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Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing

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ASTM03/01/202012

ASTM E3230 – Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-UseComponents and Assemblies Designed for Use in Biopharmaceutical Manufacturing

1.1 This practice describes the requirements for development, qualification, and routine application of a procedure for the effective liquid extraction of particulate matter from the surfaces of single-use components and assemblies designed for use in biopharmaceutical manufacturing processes. The extraction generates a suspension of particulate matter in liquid which makes the particulate matter readily available for analytical characterization.

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