Method and system for producing sterile aqueous solutions
    32.
    发明授权
    Method and system for producing sterile aqueous solutions 失效
    生产无菌水溶液的方法和系统

    公开(公告)号:US5032265A

    公开(公告)日:1991-07-16

    申请号:US541010

    申请日:1990-06-20

    摘要: A process is provided for purifying potable water to produce American Association for Advancement of Medical Instrumentation (AAMI) standard water for dialysis, United States Pharmacopeia Convention, Inc. USP XXII specifications water for injection or sterile water for injection. Potable water is passed through a plurality of treatment steps including a preliminary filtration step, a carbon adsorption module and a reverse osmosis module to produce water to the quality specified by AAMI for hemodialysis. An ion exchange filtration step is added to the steps stated above to produce USP XXII quality specifications for water for injection and a disposable sterilizing microfilter is further added to all the steps stated above to produce sterile water for injection. The process is designed such that the system is sanitized with hot water and subsequently flushed at a temperature and time that will control microbial population as specified by the user requirements without degrading the materials of construction in the treatment steps, for example at 80.degree. C. for one hour. The sterile microfilter used for the production of sterile water is a disposable device changed periodically to maintain sterility of the final solution.

    摘要翻译: 提供用于净化饮用水的方法以生产美国医疗器械进步协会(AAMI)标准用于透析的水,美国药典公约。USP XXII规范注射用水或注射用无菌水。 饮用水通过包括预过滤步骤,碳吸附模块和反渗透模块在内的多个处理步骤,以产生由AAMI为血液透析指定的质量的水​​。 在上述步骤中加入离子交换过滤步骤以产生用于注射用水的USP XXII质量规格,并且在上述所有步骤中进一步加入一次性灭菌微过滤器以产生注射用无菌水。 该过程被设计成使得系统用热水消毒,随后在温度和时间下冲洗,该温度和时间将根据用户要求规定控制微生物群体,而不会降低处理步骤中的施工材料,例如在80℃下 一小时。 用于生产无菌水的无菌微型过滤器是周期性地改变以维持最终溶液的无菌性的一次性装置。

    Process and system for producing sterile water and sterile aqueous
solutions
    35.
    发明授权
    Process and system for producing sterile water and sterile aqueous solutions 失效
    生产无菌水和无菌水溶液的方法和系统

    公开(公告)号:US4610790A

    公开(公告)日:1986-09-09

    申请号:US578950

    申请日:1984-02-10

    摘要: Water substantially free of pyrogens and microorganisms that meets the requirements of United States Pharmacopoeia Standard USP XX Water for Injection is produced by processing drinking quality water through a filtration step adapted to remove organic contaminants and impurities that degrade downstream seperation membranes, a reverse osmosis step to remove dissolved solids, pyrogens, microorganisms and chemical contamination, a deionization step to further remove dissolved solids, and an ultrafiltration step to remove pyrogens. A sterile filter to remove microorganisms increases the water quality to USP XX Sterile Water for Injection. Means are provided to periodically remove accumulated chemical contaminants, pyrogens and microorganisms from the reverse osmosis apparatus, the deionization apparatus and the ultrafiltration apparatus. The sterile water can be admixed with a sterile concentrate composition to produce a sterile dilute solution that can be packaged under sterile conditions.

    摘要翻译: 基本上不含符合美国药典标准USP XX注射用水要求的热原和微生物的水是通过适用于除去有机污染物和杂质以降解下游分离膜的过滤步骤处理饮用水而制造的,反渗透步骤 去除溶解的固体,热原,微生物和化学污染,去离子步骤以进一步除去溶解的固体,以及超滤步骤除去热原。 用于去除微生物的无菌过滤器会增加USP XX无菌注射用水的水质。 提供了用于从反渗透装置,去离子装置和超滤装置中周期性地去除积聚的化学污染物,热原和微生物的装置。 无菌水可以与无菌浓缩组合物混合以产生可在无菌条件下包装的无菌稀释溶液。

    Highly anisotropic membranes
    37.
    发明授权
    Highly anisotropic membranes 失效
    高度各向异性的膜

    公开(公告)号:US4333972A

    公开(公告)日:1982-06-08

    申请号:US162679

    申请日:1980-06-25

    申请人: Robert E. Kesting

    发明人: Robert E. Kesting

    摘要: The discovery that highly anisotropic membranes, e.g. with a degree of anisotropy of five can for the very first time be produced by the dry phase inversion process by a very specific combination of polymers, solvent and non-solvent, optionally along with plasticizers and modifiers, all of which separately are known in membrane technology, the polymers consisting essentially of cellulose nitrate and cellulose nitrate-cellulose acetate mixed ester polymers, the solvent being methyl formate, propylene oxide, or mixtures thereof, and the non-solvents being isopropyl alcohol, t-butyl alcohol or mixtures thereof, is disclosed.

    摘要翻译: 发现高度各向异性的膜,例如 通过非常特殊的聚合物,溶剂和非溶剂的组合,任选地与增塑剂和改性剂一起,通过干相转化方法首次产生五个罐的各向异性程度,所有这些都在膜中是已知的 技术中,基本上由硝酸纤维素和硝酸纤维素醋酸酯混合酯聚合物组成的聚合物,溶剂是甲酸甲酯,环氧丙烷或其混合物,非溶剂是异丙醇,叔丁醇或其混合物是 披露

    Device for dilution and delivery of in vivo chemicals
    38.
    发明授权
    Device for dilution and delivery of in vivo chemicals 失效
    用于稀释和递送体内化学物质的装置

    公开(公告)号:US4265760A

    公开(公告)日:1981-05-05

    申请号:US15480

    申请日:1979-02-26

    摘要: A collapsible disposable container for dilution and delivery of chemicals for in vivo use which includes a combination adsorbent and absolute filter for effecting sterilization and removal of endotoxins and organic contaminants from a diluent introduced into the container prior to in vivo use thereof. Such combination may be in the container inlet, container outlet or in the main storage portion thereof. Unsterilized diluent can be employed for diluting chemicals in the container.

    摘要翻译: 一种可折叠的一次性容器,用于稀释和递送用于体内使用的化学品,其包括组合吸附剂和绝对过滤器,用于在体内使用之前从引入容器的稀释剂中消毒和除去内毒素和有机污染物。 这种组合可以在容器入口,容器出口或其主存储部分中。 未使用的稀释剂可用于稀释容器中的化学物质。

    Process for rendering solids sterile
    39.
    发明授权
    Process for rendering solids sterile 失效
    使固体无菌的方法

    公开(公告)号:US4263253A

    公开(公告)日:1981-04-21

    申请号:US62275

    申请日:1979-07-30

    IPC分类号: A61L2/06 A61L2/02

    CPC分类号: A61L2/022

    摘要: The present invention relates to a process for freeing solids, in particular pharmaceutical active ingredients, from germs by sterile filtration using supercritical gases.

    摘要翻译: 本发明涉及通过使用超临界气体的无菌过滤从细菌释放固体,特别是药物活性成分的方法。

    Device and process for removing pyrogens from aqueous solutions
    40.
    发明授权
    Device and process for removing pyrogens from aqueous solutions 失效
    从水溶液中去除热原的装置和方法

    公开(公告)号:US4261834A

    公开(公告)日:1981-04-14

    申请号:US906922

    申请日:1978-05-18

    申请人: Dirk M. deWinter

    发明人: Dirk M. deWinter

    摘要: Pyrogens can be effectively removed from an aqueous solution by passing a stream of the solution through a device comprising at least two anisotropic ultrafiltration membranes positioned in series, said membranes having nominal molecular weight limits less than the molecular weight of the pyrogens, including aggregates or micelles thereof, to be removed, wherein at least one membrane is juxtaposed with at least one other membrane so that substantially all of the skin surface of one membrane is in intimate contact with substantially all of the skin surface of the other membrane and wherein the edges of one membrane are sealed to the corresponding edges of the other membrane.

    摘要翻译: 通过使溶液流通过包含串联定位的至少两个各向异性超滤膜的装置,可以有效地从水溶液中除去热原,所述膜的标称分子量极限小于热原的分子量,包括聚集体或胶束 其中至少一个膜与至少一个其它膜并置,使得一个膜的基本上所有的皮肤表面基本上与另一个膜的基本上所有的皮肤表面紧密接触,并且其中边缘 一个膜被密封到另一个膜的相应边缘。