Membranes and polymer structures--biocompatibility aspects with respect to production limits.

Plasmapheresis can be performed by centrifugation and by use of membrane technology. With the latter technique we receive a plasma which is absolutely free from platelets. This is why membranes are gaining market shares in this particular field of medical application. Today plasmapheresis membranes are mostly fabricated from synthetic polymers, such as polypropylene (e.g. PLASMAPHAN), polysulfone, polyacrylonitrile, polymethylmethacrylate, polyvinylalcohol and others, the only exception being cellulose acetate. Parameters determining the biocompatibility of plasmapheresis membranes are generation of complement C3a or C5a, hemolysis and possible thrombus formation. These parameters depend on various properties of the membrane polymer: e.g. the nature of the molecular end/side-groups, the distribution of electrical charges on the polymer surface and the different chemical structures and conformation of the polymer. In addition, membrane properties like pore distribution and geometry or the flow characteristics of a particular device-design may trigger cell activation or influence biocompatibility through the adsorption of various plasmacomponents. Most of the polymers which are used today for manufacturing plasmapheresis membranes have not been developed for this purpose. They were originally selected to be used as textile fibers. Further, no present membrane polymer has been specifically developed to achieve high biocompatibility. The membrane profile was designed in such a way that pheresis properties were met rather than optimizing biochemical blood/polymer interactions. One reason for this decision may be that the market volume of plasmapheresis technology is too small in order to justify specific and high-cost developments of polymers for this purpose. Polymer selection to achieve excellent biocompatibility profiles is determined by polymer-availability, costs, membrane-forming processes and environmental aspects related to possible pollution during the manufacturing process. The production of PLASMAPHAN by the unique Accurel-process combines several of these parameters. The main membrane production processes and especially the Accurel-process are described here. The influence of polymer-surface properties, membrane structure and module-design on the biocompatibility of plasmapheresis treatments are discussed and explained by appropriate examples.