Work Item
ASTM WK90903
New Classification for Reporting Solids and Insoluble Liquid Contamination of Water and Pharmaceutical Liquids When Analyzed by Digital Imaging Analyzers
1. Scope
The scope would be to provide a numerical classification for counts of contamination particles and droplets in the >1 micron, >10 micron and >25 micron ranges by digital image analysisKeywords
contamination; solids; pharmaceuticalRationale
This standard would provide a concise code for reporting contamination in WFI waters and other pharmaceutical fluids in order to standardize the reporting. The code would represent the cleanliness of the fluids in question and would be used by manufacturers and users alike
Work Item Status
Date Initiated: 05-21-2024
Technical Contact: Tod Canty
Item: 001
Ballot: E55.14 (25-01)
Status: Negative Votes Need Resolution