A Solution for Aging PVC Loop
PFA Loop replaces 15+ year old PVC Loop for contract pharmaceutical company.
Smith Engineering replaced an aging PVC Loop that supplied high purity water for process at a contract pharmaceutical company. The aging PVC materials in their Loop had become brittle, making it difficult to manage. Increasing biofilm and frequent positive microbial results from sampling/testing impacted their ability to use purified water for production. Contamination and aging materials caused down time and increased sanitization frequency to maintain short term usable water supply.
Smith designed a Teflon (PFA) Loop which replaced the outdated glued joint PVC Loop and use-points consisting of glued joint PVC ball valves and several stagnant dead leg areas of piping and valves. The new installed PFA Loop utilized an Air Actuated (AA) zero-dead-leg valve (ZDL) to feed steam stability chambers which only opens when makeup water is called for. Manual ZDL valves are mounted above laboratory sink use-points with sanitary disconnects and Platinum Cured tubing pointed down toward sink to allow water to drain completely when not in use leaving exposed area to dry. ZDL valves have continuous turbulent flow across ZDL valve diaphragm seal when closed or open, with no area to trap bacteria.
The new loop which included updated equipment to support and provide adequate turbulent flow (>15,000 Reynolds) and pressure needed larger Loop distribution Pump, the addition of a larger Disinfection (254nm) UV Light System used to reduce bacteria and render microbial inactive. The dead cells are removed with a more efficient updated filtration system and method to maintain loop and use-point management.
The new loop is performing above standards. Lab testing has proven no microbial activity. Post installation, 2 weeks of daily sampling/testing for qualification was performed with results proving no microbial growth. Next steps included another two weeks of sampling/testing performed twice a week. After completion of IQ/OQ/PQ of this new upgraded system and Loop, validation was completed. The equipment, Loop and use-points have since been turned over to production and in use.
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Smith Engineering is a manufacturer of high purity water treatment equipment including Reverse Osmosis, Ultrafiltration, and DI Exchange services. Smith also directly represents numerous component suppliers for filter products, piping products, instruments and cleaning chemicals.