TY - JOUR T1 - Demonstration of the Maintaining the Validated State of a System Used to Generate Water for Injection by Thermocompression JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2017.007773 SP - pdajpst.2017.007773 AU - Alberto Leyva AU - Iriac Bisquet AU - Tania de la Cruz AU - Leoner del Arco AU - Joel Ríos AU - Rodolfo Valdés AU - Sonny Robles AU - Fabian Ugarte AU - Manuel Montané Y1 - 2017/01/01 UR - http://journal.pda.org/content/early/2017/07/17/pdajpst.2017.007773.abstract N2 - Water for injection is used in multiple applications in Biopharmaceutical industry. Regarding this, several methods have been use to generate water with this high quality. Within them, the thermos-compression distillation method has been widely employed. Though, reports on the maintenance of the qualification and validation status of thermo-compression systems used for water for injection generation are non-existent in the scientific literature. Therefore, this paper sought to give evidences on continue process verification of a system used for water for injection generation during two years analyzing the level of conductivity, nitrate, total organic carbon (TOC), endotoxins and microbiology in 1284 water samples. As main results, conductivity and nitrate values were always below the specification limit defined according to United States Pharmacopeia (USP) and European Pharmacopoeia (EP), respectively, the highest TOC value measured was 156 ppb, the maximum endotoxin content detected was 0.063 EU/mL and 2 cfu/100 mL as microbiology results. As conclusion, this study demonstrated that the analyzed water for injection system operated under a validated status for two years, which was supported by an appropriate monitoring program according to current process validation guideline. ER -