Characteristics of an Ultrafiltered Deionized Water System Used in the Manufacture of Implantable Biomedical Devices

Abstract

The purpose of this paper is to demonstrate the characteristics of an ultrafiltered deionized water system used in the manufacture of biomedical devices. The water system was designed to reduce product concerns with respect to ionic contamination, organic contamination, and microbial contamination. The goal of the system was to produce high-purity deionized water that exceeded the requirements of USP pure water and meet the manufacturing requirements of electronic device assembly. This goal was achieved by using a compact design, select materials of construction, and robust pretreatment to reduce the burden to the ultrafiltration system. Continuous supply is delivered to all points of use through balanced pressures within the system and without a bulk storage tank. System maintenance is reduced to routine daily monitoring and sanitization once per month. Detailed descriptions of the system design, system operating conditions, and variable data are included to demonstrate system performance.