High quality water production for pharmaceutical use by Ozone treatment.

The pharmaceutical industry is a great consumer of high quality water, which must fulfill severe specifications concerning chemical impurities and endotoxins. In the present work, an industrial installation was built and operation parameters were searched for a high quality water production process by ozone refining treatment. In the design and building of ozonation system, and also in the techniques and procedures for the quality control assurance of the process and the final product, GMP, GLP and up-to-date Pharmacopeia were taken into account. Tap water previously treated to obtain purified water with suitable values of initial conductivity was employed for ozonation. Different ozone concentrations in the gas and in the liquid, liquid flows and the effect of ultraviolet light were assayed. A flow diagram description of the ozonation process is presented. A challenge to the system was conducted in which endotoxins were inoculated into the purified water. The effect of ozonation treatment on endotoxin content was determined. It was shown that, starting with water with good initial conductivity and by an ozonation polishing process it is possible to industrially produce high quality water for pharmaceutical use, which fulfills the international standards. A preliminary analysis showed the economic