Eudailey W A
Am J Hosp Pharm. 1983 Nov;40(11):1921-3.
The development of membrane-filtration processes is reviewed, and current types and uses of membrane filtration in health care is discussed. Development of adequate support structures for filters and of disposable filtration devices has facilitated development of filtration processes for pharmaceutical industry, manufacturing in hospital pharmacies, and direct patient care. Hydrophobic filters have also been developed; aqueous solutions cannot wet the pore structures of these filters and therefore cannot pass. Sterility-testing systems have also been developed. There are two types of filters: depth (constructed of compacted fibers) and membrane (which have a homogeneous internal structure). Depth filters retain only a portion of particles in a particular size range and are generally not acceptable for use in health care. Membrane filters retain all particles of a given size. Types of membrane filters are selected for specific uses based on needed flow rates, particulate load, and retention capability. Membrane filters may be validated using bacterial-passage, bubble-point, and diffusion tests. Most membrane filters used in health care are microporous filters that retain particles in the 0.1-10-micron size range. Applications are currently being developed for ultrafilters, which retain both particles and substances with large molecular structures such as proteins, and reverse-osmosis filter membranes, which allow only water or water-miscible solvents of very low molecular weights to pass. Experience in engineering designs, quality assurance, and test procedures has led to the development of many safe, reliable, and effective membrane products for health care.
本文综述了膜过滤工艺的发展,并讨论了当前膜过滤在医疗保健领域的类型和用途。为过滤器开发合适的支撑结构以及一次性过滤装置,促进了制药行业、医院药房生产和直接患者护理中过滤工艺的发展。还开发了疏水过滤器;水溶液无法润湿这些过滤器的孔结构,因此无法通过。无菌检测系统也已开发出来。有两种类型的过滤器:深层过滤器(由压实纤维构成)和膜过滤器(具有均匀的内部结构)。深层过滤器仅保留特定尺寸范围内的一部分颗粒,通常不适合在医疗保健中使用。膜过滤器能保留给定尺寸的所有颗粒。根据所需流速、颗粒负载和截留能力,选择膜过滤器的类型用于特定用途。膜过滤器可通过细菌透过、泡点和扩散测试进行验证。医疗保健中使用的大多数膜过滤器是微孔过滤器,可截留尺寸在0.1至10微米范围内的颗粒。目前正在开发超滤器的应用,超滤器可截留颗粒和具有大分子结构的物质(如蛋白质),还有反渗透滤膜,它只允许分子量极低的水或与水混溶的溶剂通过。工程设计、质量保证和测试程序方面的经验促成了许多用于医疗保健的安全、可靠且有效的膜产品的开发。