LEWA EcoPrime®: The Next Plateau in Control, Accuracy, and Reproducibility in Preparative Chromatography Systems

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The LEWA EcoPrime® LPLC chromatography platform combines proprietary fluid design and the LEWA Intellidrive® technology to deliver unrivaled batch-to-batch reproducibility and accuracy. The LEWA EcoPrime® features our open architecture automation software and is built on a quality control of the industry’s most vertical supply chain. A single LEWA system has the range of up to three conventional LPLC units while providing a higher level of accuracy. This gives the user great flexibility, more floor space, and plant-friendly integration with simple software customization and updating.

We have combined state-of-the-art functionalities into one unit. It can be a buffer dilution skid or directly connected to a column to be a chromatography system. Tank requirements and labor related to buffer make-up are reduced when the unit directly connects to supplies for purified water and water for injection. This system has been optimized through software analysis of fluid motive, fine-tuned over our 60-year history to enhance purification processes. Because of its dynamic range, it can bridge the gap between research and development, process development, and production functions one unit for all three stages. It combines all process-relevant accessories, ensures high reliability, and uses new flow technology that allows for self-cooling, ventilation-free pump motors.

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Advantages of LEWA EcoPrime® units include unrivaled accuracy, constant backpressure for increased precision, dynamic flow range of 1:150, and significant reduction in pulsation and hold-up volume. LEWA EcoPrime® diaphragm metering pumps reduce shear on protein solutions, and the design conforms with all pharmaceutical requirements. In addition, the units provide 0.599.5% step and linear gradient capability, state-of-the-art instrumentation, and advanced bubble-trap design for optimal degasification. They are 100% drainable and clean-in-place (CIP) capable, with optional steam-in-place (SIP) capability, and help lengthen the life of column media because they minimize pulsation.

Because production requirements may be different, LEWA can custom design a combination of pump types and flows to meet your requirements. A key differentiator is the LEWA EcoPrime® pump technology. The LEWA intellidrive technology pump package is designed to enhance the performance and reproducibility of our pumps. The intelligent drive increases the precision of LEWA Ecodos pumps to 0.5% and maximizes the pumps flow range.

LEWA’s bubble-trap design decreases the hold-up volume while reducing the residence time of gradient and samples. This allows better symmetry and reduces back mixing. LEWA provides all documentation to show that the materials used to build the systems are all traceable back to their original sources, and all plastic materials are USP Class VI certified.

LEWA EcoPrime® offers commercial and technical performance certainties; IQ/OQ documentation and execution; CGMP compliance from DQ, IQ/OQ to SAT until final acceptance; in-house design, process, and automation engineering compatible with all SCADA systems; and an audit trail to achieve 21 CFR part 11 compliance.

Control modules set the parameters for flow, gradient, pH/ conductivity, and dilution. These modules are used in sequences, which are methods designed for common chromatography processes such as water flushing, buffer priming, equilibration, product loading, column washing, product elution, column sanitization, fractionation elution, and fraction detection and collection. Ten operations can be stored and recalled. Each operation can contain up to 20 sequences.

LEWA developed its first pulseless pump for liquid chromatography in the late 1970s and delivered its first chromatography system in the early 1980s. LEWA is the leader in supplying pumps used for pilot and industrial HPLC, SMB, and LPLC chromatography worldwide. LEWA has now packaged this history of expertise in precise fluid management and automation into our newest generation of EcoPrime chromatography skids ready to be customized to your development and GMP manufacturing environment. Design consultation, manufacturing, and installation, followed by our service, spare parts supply, maintenance, and training is our 360 commercial certainty pledge. We listen to your ideas and produce a complete customized solution to meet your requirements.

Gary Gaudet is the global clean market manager for LEWA-Nikkiso America, Inc., 132 Hopping Brook Road, Holliston, MA 01746; 1-508-429-7403;
sales@lewa-inc.com; www.lewa-inc.com

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