WK95907 - New Test Method for The inline measurement of non-soluble liquid and solid contaminants in pharmaceutical liquids by dynamic imaging analyzer

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.

Details

Developed by Subcommittee: E55.14

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 08-04-2025

Technical Contact: Ethan Schrodt

Item: 000

Ballot:

Status: