主题:【原创】【第二届网络原创作品】PROCESS VALIDATION IN MANUFACTURING OF BIOPHARMACEUTICALS的翻译

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myreebok
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谢谢何大大的肯定,由于时间有限,平均10分钟一段,未来几天会慢慢修的
myreebok
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9.5 UTILITIES: DESIGN AND OPERATION 公用系统:设计和运行
The design and installation of high-quality, reliable plant utilities are crucial to the operation of a GMP facility for the manufacture of biotech products. Plant utilities include water and clean-steam systems, HVAC systems, sterilization systems, and decontamination and waste treatment systems. This section will focus on water systems and HVAC systems, but many of the principles of qualification, maintenance, and operation of these systems can be applied to all plant systems.
高质量的设计和安装,可靠的车间公用系统对于生产生物产品的GMP厂房设施的运行是至关重要的。车间公用设施包括,水和纯蒸汽系统,HVAC系统,灭菌系统和除污染、废水处理系统。本章节将专注于水系统和空调系统,但许多确认,维护,和操作这些系统的原则可以应用于所有车间系统。
myreebok
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9.5.1 Water Systems 水系统
Water is an essential component of parenteral products and probably accounts for the largest component volume utilized in manufacturing operations. The quality and consistency of high-purity water appropriate for manufacturing operations depends on several factors including (1) the quality and source of the incoming potable water, (2) choice of treatment and water purification steps, (3) design and construction features of the water system including storage and distribution components, and (4) the effectiveness of routine monitoring, preventive maintenance, and calibration programs [24].
水是非肠道产品必不可少的组分并且很可能是在制造过程中使用的量最大的组成部分。适用于生产操作的高纯水的质量和连续性依靠若干因素包括进厂饮用水的质量和来源,处理和水纯化的步骤的选择,水系统设计和建设特点包括贮存和分配组成部分和日常监测的效率,预防措施和校准程序。
myreebok
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9.5.1.1 Incoming Potable Water 进厂饮用水(下简称源水)
The incoming potable water is required to meet the Environmental Protection Agency’s National Drinking Water Regulations as set forth in Title 40 of the CFR, Part 141 [25]. These regulations specify maximum contaminant levels for organic and inorganic chemicals, turbidity, and microorganisms. It is also required by these regulations that the water be supplied under continuous positive pressure in a plumbing system free of defects that could contribute to contamination of a drug product.
源水需要满足环境保护机构国家饮用水法规在40 of the CFR, Part 141中的强制规定。这些法规规定了有机和无机化学物,浊度和微生物的最大污染程度。这些法规还要求水应通过管道设施系统在连续正压下供给并没有可能促进药品污染的缺限。
Because the incoming water quality can vary considerably, influenced by factors such as rainfall and seasonal variations, most water systems begin with a series of pretreatment steps that are chosen based on the characteristics of the incoming water. Pretreatment systems usually consist of one or more different types of filters designed to reduce chlorine, chemicals, and bioburden levels [26]. Prior to primary water purification, softening may be necessary as the final pretreatment step to substitute sodium ions for minerals containing magnesium or calcium, in order to prevent the buildup of insoluble precipitates.
因为源水质量可能差别很大,受一些因素的影响,如,雨水和季节变化,绝大多数水系统由一系列的根据源水规格参数选择的预处理步骤开始。通常预处理系统由一个或多个不同形式的设计用来减少氯离子,化学物质和生物负载等级的滤器组成。在一级水纯化之前,软化可能是必须的最终预处理步骤来去除钠离子,含有镁和钙的矿物质中的,来预防不溶性沉淀的生成。
myreebok
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9.5.1.2 Water Purification Systems 水纯化系统
Water purification systems may follow the initial pretreatment steps in various sequences depending on the characteristics of the water and the design of the system. Reverse-osmosis (RO) and deionization (DI) are common water purification steps. RO is often the first system in this series. RO systems remove a large percentage of the total dissolved solids, as well as bacteria and endotoxin, from the feed water. A well-designed, single-pass RO system will typically reject up to 95% of dissolved solids and 99% of microorganisms and endotoxin by pumping water through a semipermeable membrane from a high-solids solution to a low-solids solution, allowing water to pass and retaining the dissolved solids, organic matter, and bacteria [27].
水纯化系统可能跟随在初始的预处理步骤后面,根据水规格参数的不同有多种顺序和系统设计。反渗透(RO)和去离子(DI)是通用的水纯化步骤。RO通常是这个系列中第一个系统。RO系统去除了给水中大百分比的总溶解固体,还有细菌和内毒素。一个良好设计的,单通道的RO系统通常能通过将水输送通过半透膜从高固体溶液到低固体溶液,允许水通过并留下溶解的固体,有机物质和细菌,去除达到95%的溶解性固体和99%的微生物和内毒素。
何当奇
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如果楼主要参加原创比赛,建议加上翻译心得,思考过程之类的。
myreebok
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原文由 何当奇(redanqi) 发表:
如果楼主要参加原创比赛,建议加上翻译心得,思考过程之类的。



恩,我觉得有道理,以后一章完成会写下自己的想法,因为手头上参考资料还是很全的。也欢迎业内业外的朋友们参与探讨
何当奇
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原文由 myreebok(myreebok) 发表:
原文由 何当奇(redanqi) 发表:
如果楼主要参加原创比赛,建议加上翻译心得,思考过程之类的。



恩,我觉得有道理,以后一章完成会写下自己的想法,因为手头上参考资料还是很全的。也欢迎业内业外的朋友们参与探讨


谢谢
myreebok
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Since RO membranes retain highly charged salt ions to a greater extent than weakly ionized monovalent ions, it is often desirable to follow the RO system with an ion-exchange unit. DI water is produced by passing water through either a mixed-bed or a two-bed cation-anion exchanger to remove residual ionic components. The type of deionizer and resin capacities should be chosen based on the quality of water that is desired, the quality of the feed water, and the anticipated water volume throughput. The preinstallation analysis should also take into account the surface area of the ion-exchange resin beds, the temperature range of the system water, the operational range of the flow rates, the frequency of use of the system, the type of regenerant chemicals, and the proposed method of steam sterilization or sanitization. Such analysis will help determine how often beds will need to be regenerated and will assist in the development of maintenance schedules for the system [27].
因为RO膜截留了高电荷的盐离子比一价离子的弱电解质在多的多,通常RO系统后面跟随离子交换单元。去离子水是由将水通过单混床或两床阴阳离子交换器来去除残留的离子组分制备的。去离子设备类型和树脂量应依据理想状态下水的质量,进水质量和预期水体积产量来选择。预安装的分析仪器仪表同样也考虑离子交换树脂床的表面积,系统水温范围,流量操作范围,系统使用频次,再生化学品的类型和建议的蒸汽灭菌或消毒方法。这些仪器仪表将帮助确定混床再生的频次并促进系统维护保养计划的研发。


19楼着重讲了RO和DI的应用,这里顺序没错,但是我有几点要说明:

1,现代的纯化水系统可以不用DI,如果该纯水不是直接作用于药品生产,完全可以在两级RO以后直接使用,这时候,水的品质实际已经可以达到药典所规定的水质范围之内了,但是,值得注意的是现实中使用没有DI的这种系统很容易导致硝酸盐或亚硝酸盐的超标。

2,文章中提及的是CDI(化学去离子),随着科技的发展CDI已经逐渐的被淘汰了,现在更多的企业会使用EDI来去除剩余的离子,因为EDI不但占用地点少,而且操作方便。主流的EDI有两种,一种是常规的,一种是卷扬式(Christ 专利)。

3,RO操作中,浓水排放比例千万不要乱改,最好由自控系统来控制,不然会极大影响产水质量,并降低膜使用寿命。

4,RO进水最适宜的温度是根据RO膜来制定的,最好增加保温或加热,使冬天水温不要偏低来延长膜使用寿命。

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Last edit by myreebok
影子
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原文由 myreebok(myreebok) 发表:
19楼着重讲了RO和DI的应用,这里顺序没错,但是我有几点要说明:

1,现代的纯化水系统可以不用DI,如果该纯水不是直接作用于药品生产,完全可以在两级RO以后直接使用,这时候,水的品质实际已经可以达到药典所规定的水质范围之内了,但是,值得注意的是现实中使用没有DI的这种系统很容易导致硝酸盐或亚硝酸盐的超标。

2,文章中提及的是CDI(化学去离子),随着科技的发展CDI已经逐渐的被淘汰了,现在更多的企业会使用EDI来去除剩余的离子,因为EDI不但占用地点少,而且操作方便。主流的EDI有两种,一种是常规的,一种是卷扬式(Christ 专利)。

3,RO操作中,浓水排放比例千万不要乱改,最好由自控系统来控制,不然会极大影响产水质量,并降低膜使用寿命。

4,RO进水最适宜的温度是根据RO膜来制定的,最好增加保温或加热,使冬天水温不要偏低来延长膜使用寿命。



楼主最好将说明或心得之类的直接写在该楼的下面,比方说此段可以直接放在19楼,这样更便于他人阅读。谢谢!
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Last edit by hyheying