1. Scope

Keywords

Rationale

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.