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ASTM E3060-16

Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy

NORMA vydána dne 1.6.2016

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The information about the standard:

Designation standards: ASTM E3060-16
Note: NEPLATNÁ
Publication date standards: 1.6.2016
The number of pages: 14
Approximate weight : 42 g (0.09 lbs)
Country: American technical standard
Kategorie: Technické normy ASTM

Annotation of standard text ASTM E3060-16 :

Keywords:
biologics, biopharmaceutical, diameter, direct imaging, droplet, dynamic imaging, flow imaging, flow microscopy, parenteral, particle, particle size distribution, protein, protein aggregates, subvisible particle,, ICS Number Code 11.100.20 (Biological evaluation of medical devices)