Work Item
ASTM WK95907
New Test Method for The inline measurement of non-soluble liquid and solid contaminants in pharmaceutical liquids by dynamic imaging analyzer
1. Scope
The measurement of particles or droplets greater than 1µm in size, reported in size categories defined by ISO 3.
Keywords
Water for Injection; CIP; Particle Count
Rationale
The current system of sampling causes erroneous results due to contamination and limited volumes. In addition, the time delay can result in downstream contamination which can affect product integrity.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 08-04-2025
Technical Contact: Ethan Schrodt
Item: 000
Ballot:
Status: