RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP pdajpst.2017.007773
DO 10.5731/pdajpst.2017.007773
A1 Alberto Leyva
A1 Iriac Bisquet
A1 Tania de la Cruz
A1 Leoner del Arco
A1 Joel Ríos
A1 Rodolfo Valdés
A1 Sonny Robles
A1 Fabian Ugarte
A1 Manuel Montané
YR 2017
UL http://journal.pda.org/content/early/2017/07/17/pdajpst.2017.007773.abstract
AB 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.