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

浏览 |回复30 电梯直达
myreebok
结帖率:
100%
关注:0 |粉丝:0
新手级: 新兵
Other systems that may be a part of the water purification system include ultraviolet (UV) sterilizing units and ultrafiltration (UF) systems. The purpose of UV irradiation is to damage bacterial DNA to control bacterial growth, and these units are often located downstream of the DI unit since deionization does not remove microbial contamination. A UF unit may be placed in a water system to remove nonviable particles and bacteria as well as organic and colloidal material. UF employs the use of a variety of membranes whose pores range in size from approximately 0.003 to 0.006 μm in diameter [24,27]. Ultrafilters are often intended to remove pyrogens whose sizes generally range from 1.5 to 3000 kDa molecular weight.
其他系统也可以使水纯化系统的一部分包括紫外灭菌单元和超滤系统。UV照射的目的是破坏细菌的DNA来控制细菌增长。这些单元通常位于在去离子单元的下游,因为去离子不能去除微生物污染。超滤单元在水系统中用来去除无活性粒子和细菌与有机及胶体物质。超滤采用了使用多种不同孔径直径范围在0.003到0.006um膜。超滤通常用来去除范围为1.5到3000kDa摩尔质量的热源。


心得体会:
超滤一直是一个很纠结的问题,因为它很贵。。。而且。。作为CW(城市用水)来说(中国的地球人都知道自来水的水质是咋样的),预处理用超滤实在是一个很奢侈的选择。但是,相比较石英砂过滤和活性炭过滤来说。。。它的优势又是十分明显的,想想处理10T/小时的水需要多大的活性炭罐吧。。。想想活性炭更换的恐怖吧。。。再想想活性炭消毒。。。去除余氯的问题。。。。头都800个大了。。。纠结啊。。。实在是很纠结。。。但是奉劝大家。。。有米的,一定要选超滤。。。
赞贴
0
收藏
0
拍砖
0
Last edit by myreebok
myreebok
结帖率:
100%
关注:0 |粉丝:0
新手级: 新兵
Water that has been purified by RO or DI systems is often intended to meet the U.S. Pharmacopoeia (USP) Purified Water (PW) specifications and may be used for a number of applications. These applications may include initial cleaning of equipment, preparation of bacteriological media for fermentation, and feed water for the system intended to produce water for injection (WFI) [24].
用RO或DI系统纯化过的水通常是为了符合USP纯化水标准并可能用于很多种用途,这些同于可能包括初始的设备清洁,制备发酵所需的细菌培养基和用来制备注射用水的系统的源水。
myreebok
结帖率:
100%
关注:0 |粉丝:0
新手级: 新兵
9.5.1.3 Distillation 蒸馏
Distillation is the most common method for production of WFI from feed water that generally meets USP PW specifications. There are three system areas to be considered in the construction and design of the WFI system: the WFI purification unit, the distribution system, and the storage system for the water. Water purification by distillation is accomplished by heating to convert water into vapor, which then passes over a condenser and is cooled to liquid [26]. Dissolved mineral matter is not volatile at the boiling point of water and remains behind. There are various types of distillation stills including single-effect, multiple-effect, and vapor recompression stills.
蒸馏是最普遍的从符合USP纯化水标准的源水制备WFI的方法。在建造和设计WFI系统的时候需要考虑三个系统区域:WFI纯化单元,蒸馏系统和水贮存系统。蒸馏水是用加热来转换水至气态,然后通过冷凝器冷却至液态来实现的。溶解的矿物质在水的沸点是不挥发的并留下。蒸馏釜(蒸馏设备)有多种类型包括单效,多效和蒸汽再压缩釜。
myreebok
结帖率:
100%
关注:0 |粉丝:0
新手级: 新兵
9.5.1.4 Storage and Distribution Systems 贮存和分配系统
The distribution system design is critical to the overall performance of the WFI system. Probably the most common system design is composed of a distribution loop that recirculates water at 80°C with point-of-use heat exchangers to cool the water to the appropriate temperature for the desired operations and a storage tank of adequate size to meet the greatest water demands that may be anticipated [24]. Cold or ambient distribution loops are sometimes employed when large volumes of water are needed for production steps such as media and buffer preparation. A dual hot loop/cold loop may be designed to maintain a comparatively large inventory of 80°C WFI in a recirculating loop, while a smaller inventory of cool water is circulated in a separate loop. There should be provisions for ambient or cold loops to be maintained at 80°C during periods of nonuse to inhibit microbial growth [24]. The period of time the water must be elevated to 80°C should be based on validation data. Finally, the distribution system should be capable of sanitization, preferably by steam sterilization.
分配系统的设计对注射用水系统的总体性能是关键的。可能最普遍的系统设计是由….80度循环水与使用点换热器将水冷却到操作所需的适宜温度和足够容纳预期最大水量大小的储罐组成的循环管路。冷水或常温分配管路有时用于需要大量水的生产步骤如培养基和缓冲溶液配制。双热/冷循环的设计可能用来维持循环管路中比较大量的80度WFI,同时小量的冷水在另一个独立的管路中循环。应有常温或冷却循环管路在不使用时期在80度下保持的规定来抑制微生物滋长。水升温至80度的时间应有验证数据来支持。最后分配系统应能消毒,最好是蒸汽灭菌。
myreebok
结帖率:
100%
关注:0 |粉丝:0
新手级: 新兵
9.5.1.5 Materials of Construction 建设的材料
Materials of construction for the piping and distribution systems must be resistant to corrosion and should minimize contamination [28]. Ideally, stainless steel piping should be used throughout the system to meet these requirements; however, plastic piping is less expensive and is often used in the systems that produce feed water for the distillation unit. The recommended composition of the distillation unit as well as its storage and distribution systems is stainless steel AISI grade 316L or better, L referring to low carbon grade [28]. Tubing and the fittings of the distribution should have interior surfaces that are smooth, uniform, and free of pits and crevices where organic matter could lodge and contaminate the system. The smooth interior surface is achieved through mechanical polishing and generally followed by electropolishing, which removes the surface layer and its impurities. The components of the distribution and storage systems should be permanently joined in a sanitary manner. A welding method that produces welds that are smooth and free of defects such as automatic orbital welding should be employed. The locations of all welds should be documented on system blueprints and all welds should be inspected for defects as part of the water system validation.
建造管道和分配系统的材料必须抗腐蚀并且最大程度减少污染。理想的,不锈钢管道应在整个系统中使用来达到要求;然而塑料管道更便宜并且经常用于生产蒸馏设备源水的系统中。推荐的蒸馏单元组件和其贮存与分配系统式AISI 316L级不锈钢或更好的,L是低碳等级的意思。分配系统的管配件在有机物质可能积存和污染系统的地方,应有内表面平滑、均匀,没有坑和裂缝。平滑的内表面是通过取出表面层和杂质的机抛和在次之后再电抛得到的。分配和贮存系统的组件应永久地使用消毒方法。应使用产生平滑无缺陷的焊缝的焊接方法例如自动轨道焊。所有焊缝的位置应在系统蓝图上标注并且所有的焊缝应检查缺陷应作为水系统验证的一部分。
myreebok
结帖率:
100%
关注:0 |粉丝:0
新手级: 新兵
Fittings in the system should be of sanitary design and should meet the 3-A sanitary design and component standards [28]. Joints in the WFI system should be minimized to prevent leaks and bacterial growth. Stainless steel diaphragm valves are recommended.
系统中的配件应有卫生实际并应符合3A卫生设计和组件标准。WFI系统中的连接处应减至最少来预防泄漏和微生物滋长。推荐使用不锈钢隔膜阀。
Proper design of the piping distribution system should facilitate water circulation. Dead legs of more than six pipe diameters are not permitted in order to prevent areas of stagnant water where bacterial contamination may occur.
管路分配系统的恰当设计应促进水循环。为预防细菌污染可能产生的死水区域超过6倍管径的死角是不允许的。
Piping must be sloped to ensure proper drainage of water, and sufficient pressure must be supplied to maintain turbulent flow [28].管道应倾斜来确保适当的水排放,并且应提供充足的压力来维持湍流状态。


本楼最初的3A标准目前已经很少在制药行业使用了,现在该标准主要应用于食品和化妆品行业。推荐使用ISO 2037或ASME-BPE的标准
myreebok
结帖率:
100%
关注:0 |粉丝:0
新手级: 新兵
9.5.1.6 Passivation钝化
Once installed, the system should be cleaned and passivated. Passivation is a method by which chemical agents react with metal surfaces to render the surfaces nonreactive. Following cleaning and passivation, the water system should be qualified and validated to ensure that it consistently produces water of the appropriate quality [24]. 一旦安装后,系统应清洁和钝化。钝化是由化学试剂与金属表面产生反应给与表面不反应的方法。在清洁和钝化后,水系统应确认和验证来确保它连续生产符合适当质量的水。
myreebok
结帖率:
100%
关注:0 |粉丝:0
新手级: 新兵
9.5.1.7 Water System Qualification 水系统确认
Operational checks of all components of the water system should be performed using calibrated monitoring instruments including conductivity meters, temperature-sensing devices, pressure-sensing devices, and flow meters [26]. Temperatures in loops and storage tanks, as well as during sanitization or steam sterilization procedures, should be monitored. Performance qualification should include intense monitoring of all use points on the system as well as other key sites including the incoming potable water source, feed water to the still, the still outlet, and storage tanks. The water quality following each pretreatment and purification step should also be monitored. After the initial performance qualification, a routine monitoring schedule should be established for all of these components [24]. Routine monitoring of the water system is discussed in more detail in Section 9.7.
所有水系统部件运行检查应使用经校准的监测仪器进行,包括电导仪,温度传感设施,压力传感设施和流量计。循环管路,储罐和消毒或蒸汽灭菌程序期间中的温度,应有监控。性能确认应包括严密监测系统上所有的使用点和其他关键处包括进饮用水,蒸馏源水,蒸馏出口和储罐。应监测每一步预处理和纯化后的水质。在最初的性能确认后,应对所有部件制订日常监控计划。水系统的日常监控在9.7中汇更详细的讨论。
穿越时空
结帖率:
100%
关注:0 |粉丝:0
新手级: 新兵
ja19840616
结帖率:
100%
关注:0 |粉丝:0
新手级: 新兵
翻译的比较准确 ,也比较严谨
Furthermore, developing technologies, both analytical and manufacturing, can impact validation, and it is expected that sponsors of biopharmaceuticals will remain current with new developments.
此外,发展中的科技,分析和生产的,都能影响验证,希望生物制药的赞助商将持续(支持)现在的新研究。

但个别这样的句子还略需优化