Abstract
An ambient loop USP purified water system has been designed and implemented using carbon and ion exchange resin beds, ultraviolet light systems and polishing filters to produce water consistently meeting or exceeding all USP XXIII quality specifications for purified water. The circulation system is constructed of PVDF plastic piping material installed in a continuous fully-drainable loop. The system was sized for a pilot scale fermentation/harvest process at the 1000 l cultivation scale. This system passed all installation and operational qualification testing as well as sixty days of continuous performance qualification testing before entering into an ongoing monitoring regimen. Excursions outside acceptable water quality parameters during this extensive monitoring regimen were minimal. Sanitization of the system, along with bed and filter changes at the time of sanitization, was conducted every 3 to 6 months to insure consistent water quality.
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