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OPTIMIZED DECONTAMINATION PROCESS FOR STARCH AS A RAW MATERIAL FOR THE PRODUCTION OF GLUCOSE POLYMERS FOR PERITONEAL DIALYSIS

机译:淀粉作为腹膜透析生产葡萄糖聚合物用原料的优化去污工艺

摘要

The present invention concerns a method for decontaminating the starches used as a raw material for the preparation of glucose polymers intended for peritoneal dialysis, the method comprising the following steps: —preparing a Waxy corn starch, —placing the Waxy starch in suspension at a concentration of between 20 and 40% dry matter in a process water at a pH of between approximately 5 and approximately 6, in particular approximately 5.5, —treating the starch suspension with a peracetic acid solution at a concentration equal to or between 100 and 500 ppm, preferably 300 ppm, —dewatering the starch, then dissolving in demineralised water adjusted to a pH of between approximately 5 and approximately 6, in particular approximately 5.5 and at a concentration of between 20 and 40% dry matter, —increasing the temperature to 107° C., then adding an alpha-amylase for 15 minutes, —optionally, treating with an enzymatic preparation having detergent and clarification properties, —filtering the suspension on a bed of diatoms, —treating with an active carbon having a very high adsorption capacity, of pharmaceutical quality, and of “microporous” Porosity, —treating with a second active carbon of “mesoporous” porosity, —optionally, passing over a macroporous adsorbent polymer resin, having a porosity greater than 100 angstroms, —optionally, continuous 5000 Da ultrafiltration, —safety filtration through a sterile filter having a porosity of 0.22 μm.
机译:本发明涉及对用作制备用于腹膜透析的葡萄糖聚合物的原料的淀粉进行去污的方法,该方法包括以下步骤:-制备蜡状玉米淀粉,-将蜡状淀粉以一定浓度放置在悬浮液中。 -在pH值约为5至6,特别是约为5.5的工艺水中添加20%至40%的干物质,-用过乙酸溶液处理淀粉悬浮液,其浓度等于或介于100和500 ppm之间,最好是300 ppm,-将淀粉脱水,然后溶解在软化水中,该软化水的pH值约为5至6,特别是约为5.5,且干物质浓度为20至40%,-将温度提高至107° C.,然后加入α-淀粉酶15分钟,-(可选)用具有去污剂和澄清特性的酶制剂处理,-过滤在硅藻床上进行雾化,-用具有极高吸附能力,药物质量和“微孔”孔隙率的活性炭处理,-用“中孔”孔隙率的第二种活性炭处理,-可选地,经过硅藻土孔隙率大于100埃的大孔吸附聚合物树脂,-可选地,连续进行5000 Da超滤,-通过孔隙率为0.22μm的无菌过滤器进行安全过滤。

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