DILUTING FLUID D (as per USP)

Description

Diluting Fluid D is recommended as rinsing fluid for membrane filter method used in validation tests for bacteriostasis and fungistasis activity of pharmaceutical articles before carrying out sterility test procedures as per USP. After filtering the specified quantity of the test specimen, the membrane is rinsed with measured portions of rinsing or diluting fluid. This rinse is inoculated with known number of test bacteria and fungi as specified in pharmacopoeia. The resultant growth is compared with positive control to determine presence of fungistasis or bacteriostasis activity in test specimen. This medium is recommended for articles containing lecithin or oil or for devices labeled as sterile pathway.