Performance QualificatioN of the Water Treatment System of the Parenteral Products Plant 3

Abstract

The performance qualification of the purified water treatment system of the Parenteral products Plant 3 at the National Center for Bioproducts, with the aim to establish documented evidence that such a system fulfils consistently with the quality declared specifications, is presented. To accomplish this goal, a validation protocol was prepared and carried out. In this work the functional qualification is presented, which contains a sampling program divided in three phases. Phase 1, with duration of 2 weeks, in which the system is operated and sampled daily. This period of time serves to develop the cleaning and sanitation procedures and to establish the operating parameters. Phase 2, with a reduced sampling frequency in one month, intends to demonstrate that the purified water system is capable to consistently produce water with the required quality,
operated with the procedures established in phase 1. Finally, in phase 3, sampled for approximately one year, the system will be watched to check if it is operating under the established procedures and if it consistently produces water with the required quality. The x-R control graphs of the compiled data of the variables: pH, conductivity, microbiological count and others were prepared and the final product, purified water, was evaluated using the capability indexes Cp y Cpk. The results of this work demonstrated that the purified water treatment system is under statistical
control and that the water produced fulfils with the established specifications.