AN AMBIENT WATER LOOP SYSTEM FOR USP PURIFIED WATER

An ambient loop USP purified water system has been designed and implem ented using carbon and ion exchange resin beds, ultraviolet light syst ems and polishing filters to produce water consistently meeting or exc eeding all USP XXIII quality specifications for purified water. The ci rculation system is constructed of PVDF plastic piping material instal led in a continuous fully-drainable loop. The system was sized for a p ilot scale fermentation/harvest process at the 1000 1 cultivation scal e. This system passed all installation and operational qualification t esting as well as sixty days of continuous performance qualification t esting before entering into an ongoing monitoring regimen. Excursions outside acceptable water quality parameters during this extensive moni toring regimen were minimal. Sanitization of the system, along with be d and filter changes at the time of sanitization, was conducted every 3 to 6 months to insure consistent water quality.