Work Item
ASTM WK95913
New Test Method for Analyzing Particulate Content of Water for Injection and Clean Pharma Fluids Caused by Spallation of Tubing Used With Peristaltic Pumping Systems
1. Scope
This practice describes a procedure to test laboratory tubing of various plastic tube materials for spallation caused during the pumping of water for injection (WFI) and pharma fluids using a dynamic imaging analyzer (DIA). The range of particle sizes to be detected is 1 µm to 300 µmKeywords
Particle CountingRationale
Without a method to test pump and tube combinations, clean fluids may be contaminated by the process equipment. Referenced standards USP 788 and USP 1788 have very low allowable particulate counts for parenteral fluids. WFI fluids also have similar constraints on particulate maximums. When followed, the test procedure will indicate the level of contamination in a clean fluid that is produced by the interaction of the pump and tubing.
Work Item Status
Date Initiated: 08-04-2025
Technical Contact: Ethan Schrodt