Paul Mueller Company PyroPure Multiple-Effect Stills The Mueller PyroPure P6000 Series is Built to Last Mueller PyroPure multiple-effect stills (MES) are the simplest, most reliable means of producing pyrogen-free waterfor-injection (WFI) that meets all U.S. Pharmacopoeia requirements. The MES is designed with efficiency in mind. Because the system recovers the latent heat of vaporization occurring within its own process to heat feedwater and uses feedwater as its primary source of cooling, the MES is an energy and money-saving model of ingenuity. Due to the absence of moving parts, the PyroPure MES requires less maintenance and is much quieter than mechanical compression stills. Multiple-effect stills also lack the seal and associated oil supply required by mechanical compression stills; therefore, there is no danger of contamination due to seal breakdown associated with mechanical compression. The PyroPure MES is manufactured according to FDA current Good Manufacturing Practices (cGMPs) and ASME-BPE requirements. Each PyroPure MES is designed to minimize operating costs associated with production of WFI by minimizing the required utility steam and coolant consumption. This is accomplished by utilizing sources of energy within the various process streams to preheat the feedwater and thus use the feedwater as a cooling source. Using the feedwater as a coolant source also reduces the utility steam consumed to elevate the temperature of the feedwater. The feedwater ultimately enters the tubes of the first effect evaporator where utility steam is applied to the shell to evaporate the feedwater. The resulting steam produced is then directed to the separation column where a tangential inlet produces centrifugal force that separates the entrained water droplets away from the pure steam. This pure steam is then used as the heating source for the subsequent effect. Simple Design, Reliable Operation • External evaporators access for inspection and preventative maintenance on critical o-rings and gaskets. • The separation columns contain no internal components that require inspection or periodic maintenance. • All maintenance, including replacement of critical components, can be performed with only 24" of space on all sides (including the top) of the equipment. • ASME-BPE certified fittings are used throughout. • WFI condensers have removable tube bundles for easy cleaning and inspection of product contact surfaces. • Minimal instrumentation is required upon operation of the equipment. Only two control loops are needed which minimizes the calibration required as well as the potential for downtime. • All elastomers in contact with feedwater and product are provided with USP Class VI certifications. • All components are fully drainable including the optional feedwa

As the pure steam is condensed in the shell side of the subsequent evaporator, the resulting WFI flows through feedwater preheating devices and to the WFI condenser for subcooling to the required product temperature. Only pure steam discharged from the last effect of the still is condensed in the product condenser. The final product as well as the feedwater supplied to the still is measured for conductivity to ensure compliance with specifications. Control of the multiple-effect still is accomplished by two control loops. The first control loop monitors the first effect temperature and manipulates...

Distillate waste Sample outlet Paul Mueller Company The Mueller PyroPure P6000 Series is Built to Last