On-line preparation of solutions for dialysis: practical aspects versus safety and regulations.
On-line preparation of solutions for dialysis: practical aspects versus safety and regulations.
复制标题
在线制备透析溶液：实际问题与安全性和法规。
DOI：
--
复制
发表时间：
2002
影响因子：
13.6
通讯作者：
I. Ledebo
中科院分区：
文献类型：
--
作者：
I. Ledebo
1964 年，透析液引入了在线配制，即连续混合和立即使用，通过简化操作、改进微生物学和提高效率，为透析治疗的扩展做出了重大贡献。早在 1978 年，在线制备的血液滤过替代溶液就被证明具有临床安全性，但由于监管保守主义，实施推迟了 20 年。在线制备用于输注的无菌无热原溶液是基于使用水和浓缩物，这些水和浓缩物产生最少的微生物，并在卫生设计和维护的流路中混合和分配。具有已知截留能力的超滤器被放置在战略位置并确定尺寸以去除细菌和内毒素，从而按照药典对无菌产品的要求，提供至少六个等级的无菌保证水平。在在线系统的设计、验证和故障排除时应应用流体的微生物测试，但不应用于常规质量控制，因为它仅提供回顾性信息。质量保证必须融入系统及其运作方式中。如果执行得当，在线液体制备是安全、简单且具有成本效益的，并且可以提高透析治疗的效率和生物相容性。
On-line preparation, i.e., continuous mixing and immediate use, was introduced for dialysis fluid in 1964, and it contributed significantly to the expansion of dialysis therapy through simplified handling, improved microbiology, and enhanced efficiency. On-line prepared replacement solution for hemofiltration was shown to be clinically safe as early as 1978, but the implementation was delayed for 20 yr because of regulatory conservatism. On-line preparation of sterile and pyrogen-free solutions for infusion is based on the use of water and concentrates that contribute a minimum of microorganisms and are mixed and distributed in a hygienically designed and maintained flow path. Ultrafilters with known retention capacity are placed in strategic positions and dimensioned to remove bacteria and endotoxins, which gives a sterility assurance level of at least six magnitudes, as required by the Pharmacopoeia for sterile products. Microbiologic testing of the fluid should be applied when designing, validating, and troubleshooting on-line systems but not for routine quality control, because it only gives retrospective information. Quality assurance has to be built into a system and the way it is operated. On-line fluid preparation, when properly performed, is safe, simple, and cost-effective and enhances the efficiency as well as the biocompatibility of dialysis therapy.
人肾同种异体移植排斥：分子特征。
DOI：
10.1093/ndt/13.suppl_1.21
发表时间：
1998
期刊：
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
影响因子：
--
作者：
Suthanthiran,M
通讯作者：
Suthanthiran,M