Burrows W D, Nelson J H
U.S. Army Biomedical Research and Development Laboratory, Fort Detrick, Frederick, MD.
J Parenter Sci Technol. 1993 May-Jun;47(3):124-9.
Two approaches have been investigated for generating USP sterile, pyrogen-free water for injection (WFI) from potable water in the field. The first approach utilizes reverse osmosis (RO), ion exchange, a solid matrix filter containing activated carbon and zeta adsorbent, a final 0.2 microns pore size sterilizing filter and a device for transferring the WFI to an IV bag; prototype systems based on three different hand-operated RO units weigh 1.5-3.5 kg and are capable of producing WFI at rates of 1-10 L/hr. Parenteral solutions were made by adding WFI to an IV bag containing concentrated Ringer's lactate. The second approach, still in the breadboard stage, is similar but utilizes a larger ion exchange column in place of the RO unit and a multiport distribution head to fill a set of 18 1-L IV bags. This system, considered to be disposable, is capable of generating water of WFI quality at a fill rate of 0.5 L/min from a pressurized source.
已经研究了两种在现场从饮用水制备美国药典（USP）无菌、无热原注射用水（WFI）的方法。第一种方法利用反渗透（RO）、离子交换、一种含有活性炭和ζ吸附剂的固体基质过滤器、一个最终孔径为0.2微米的除菌过滤器以及一个将WFI转移至静脉输液袋的装置；基于三种不同手动RO单元的原型系统重量为1.5至3.5千克，能够以1至10升/小时的速率生产WFI。通过将WFI添加到含有浓缩乳酸林格氏液的静脉输液袋中来制备肠胃外溶液。第二种方法仍处于实验模型阶段，与之类似，但使用一个更大的离子交换柱代替RO单元，并使用一个多端口分配头来填充一组18个1升的静脉输液袋。该系统被认为是一次性的，能够从加压源以0.5升/分钟的填充速率生产符合WFI质量标准的水。
