WK90903 - New Classification for Reporting Solids and Insoluble Liquid Contamination of Water and Pharmaceutical Liquids When Analyzed by Digital Imaging Analyzers

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 analysis

Keywords

contamination; solids; pharmaceutical

Rationale

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

Details

Developed by Subcommittee: E55.14

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 05-21-2024

Technical Contact: Tod Canty

Item: 001

Ballot: E55.14 (25-01)

Status: Negative Votes Need Resolution

New Classification for Reporting Solids and Insoluble Liquid Contamination of Water and Pharmaceutical Liquids When Analyzed by Digital Imaging Analyzers

1. Scope

Keywords

Rationale

Details

Work Item Status

Related

New Classification for Reporting Solids and Insoluble Liquid Contamination of Water and Pharmaceutical Liquids When Analyzed by Digital Imaging Analyzers

1. Scope

Keywords

Rationale

Details

Work Item Status

Related