Ledebo I, Nystrand R
Renal Care R&D, Gambro, Lund, Sweden.
Artif Organs. 1999 Jan;23(1):37-43. doi: 10.1046/j.1525-1594.1999.06275.x.
With increasing awareness about the degree and the potential impact of microbiological contamination in dialysis fluids, there is a desire to improve their microbiological quality. To achieve this goal, the origin of the microbiological contamination has to be identified. The water, the bicarbonate concentrate, and the fluid distribution system can be major contributors. Regular disinfection of the entire fluid path is necessary to prevent the formation of biofilm. The bicarbonate concentrate should be handled with special attention because it constitutes an excellent growth medium for microflora that may not be detected with regular assays. With a well maintained reverse osmosis (RO) system, frequent disinfection of the entire flow path, and microbiological awareness, it is possible to produce dialysis fluid that meets the most stringent standard (<10(2) colony forming units (CFU)/ml and <0.25 IU/ml of endotoxin). Adding a step of ultrafiltration just before the dialyzer can make the dialysis fluid ultrapure (<10(-1) CFU/ ml and <0.03 IU/ml). One additional step of controlled ultrafiltration provides sterile and pyrogen-free fluids (<10(-6) CFU/ml and <0.03 IU/ml) that can be used for infusion.
随着人们对透析液中微生物污染程度及其潜在影响的认识不断提高，人们希望改善透析液的微生物质量。为实现这一目标，必须确定微生物污染的来源。水、碳酸氢盐浓缩液和液体分配系统可能是主要污染源。对整个液体路径进行定期消毒对于防止生物膜形成是必要的。应特别注意处理碳酸氢盐浓缩液，因为它是微生物的优质生长培养基，常规检测可能无法检测到其中的微生物。通过维护良好的反渗透（RO）系统、对整个流动路径进行频繁消毒以及具备微生物意识，有可能生产出符合最严格标准（<10² 菌落形成单位（CFU）/毫升且内毒素<0.25 国际单位/毫升）的透析液。在透析器前增加一步超滤可使透析液超纯（<10⁻¹ CFU/毫升且<0.03 国际单位/毫升）。再增加一步控制超滤可提供无菌、无热原的液体（<10⁻⁶ CFU/毫升且<0.03 国际单位/毫升），可用于输液。
