USD 2610 PallSep™ Biotech Systems A gentle, efficient separation technology for complex biotech harvest and clarification applications Vibrating Membrane Filtration (VMF) technology prevents the accumulation or build-up of retained species at the membrane surface and subsequent membrane fouling. Requires much lower cross flow and transmembrane pressure (TMP) than traditional TFF technologies, resulting in lower energy consumption and allowing better protein transmission. Offers gentle product treatment, even with high suspended solids levels. Simplifies scale up. Filter modules are available in 0.2, 1 and 5 m² surface areas for more flexibility and easy scale up or scale down. Encapsulated module is easy to use and replace. Expands processing options. Users may combine different process steps within the same system (for example, harvest and clarification steps). Compact design reduces the system footprint. Applications Concentration, clarification and purification of high particle load, high viscosity or difficult-to-filter solutions such as: Fermentation broths Lysates These solutions are used in the production of high value products, for example, therapeutic vaccines or antigen extracts. Description Technical Specifications Tangential flow filtration (TFF) is well established in biotechnological applications for the concentration and diafiltration of proteins and cell harvest. However, the energy input to achieve the required cross flow rates is high and the generated shear effect can damage sensitive target molecules. Innovative dynamic filtration systems using microporous membranes may be used as an alternative. Materials of Construction The new PallSep Biotech System is suitable for the gentle separation of target molecules from complex process fluids containing high levels of biomass/particulates and high viscosity. The shear forces generated by Vibrating Membrane Filtration (VMF) are limited to a narrow layer on the membrane surface, thus the bulk of the process fluid is not exposed to the shear. In addition, the required cross flow is much lower when compared to other TFF technologies. The system allows for a dynamic membrane filtration with lower energy input and gentle processing of the target molecule with a low pressure drop. The PallSep Biotech System consists of encapsulated 0.2 µm polyethersulfone (PES) filter modules with filter areas of 0.2 m², 1 m² and 5 m², which allow for process development and full-scale production. All critical GMP requirements for biopharmaceutical processes are met without compromising the ease of use, flexibility, cleanability, safety or operating costs. The PallSep Biotech System uses an offset motor that induces oscillation of two masses (the membrane module and a seismic plate) connected by a torsion rod. Operation close to the resonance frequency of ~50 Hz leads to a very low energy input to maintain the oscillation of the two masses. The oscillation prevents particulates from accumulating at the membrane surface and thus fouling the membrane surface. A stable permeate flow is maintained while achieving high levels of product transmission, even with high particulate density and viscosity. Designed to meet customer-specific requirements, the PallSep Biotech System includes all the valves, pumps, sensors, vessel and piping elements mounted on a skid assembly to operate the unit, either in manual or automated conditions. Quality Standards Modules are manufactured under a system of Quality Management certified to ISO 9001:2000 Quality System Standard and 100% integrity tested during manufacture. PallSep Biotech Module Membrane Membrane Support Plate Membrane Drainage Layer Spacers Encapsulant O-rings/Gaskets Housing Core 0.2 µm polyethersulfone Polyolefin copolymer Polyolefin Polyester Epoxy resin EPDM Fiber reinforced plastic Polysulfone PallSep Biotech PS50 Base Unit Tubings and Fittings Surface Finish 316 L stainless steel ≤ 0.5 µm internal ≤ 0.8 µm external Platinum cured silicone EPDM Hoses with Integral Fittings Gaskets Operating Parameters Maximum Operating Pressure at Ambient Temperature Maximum Operating Pressure Maximum Transmembrane Pressure (TMP) Maximum Operating Temperature Minimum Operating Temperature 4.2 barg (60 psig) 4.2 barg (60 psig) 3.5 barg (50 psig) 50 ºC 4 ºC Ordering Information Part Number Module Description Pkg VMFPSM20B02 VMFPSM20B10 VMFPSM20B50 0.2 m² PallSep Biotech module 1 m² PallSep Biotech module 5 m² PallSep Biotech module 1/pkg 1/pkg 1/pkg Note: Each module is delivered with one set of the gaskets required for the installation of the module into the PallSep Biotech PS50 base unit. PallSep Biotech System Please contact your Pall representative for more information Each module is delivered with a certificate of quality. Visit us on the Web at www.pall.com/biopharm e-mail us at biotech@pall.com United States 800.717.7255 toll free (USA) 516.484.5400 phone 516.801.9548 fax biotech@pall.com e-mail Europe +44 (0)23 9230 3303 phone +44 (0)23 9230 2506 fax BioPharmUK@europe.pall.com e-mail International Offices Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela. Distributors in all major industrial areas of the world. The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly. © 2009, Pall Corporation. Pall, , and PallSep are trademarks of Pall Corporation. ® indicates a trademark registered in the USA. Filtration. Separation. Solution. is a service mark of Pall Corporation. SM 10/09, PDF, UK GN09.2894 USD 2610