ISPE 4预处理选项Word文件下载.docx

1、反渗透很特别，因为它即可以是一个预处理步骤，另外还能是一个终处理步骤。本章和第11章将讨论反渗透作为预处理的情况，而将其作为一门技术的情况将在5、6章中详述。The initial sections of this chapter discuss the process design （programming issues） for pretreatment design including feed water quality and output water quality from pretreatment. The chapter then discusses the selectio

2、n of treatment options （i.e. unit operations） for four groups of impurities:本章的开始部分讨论预处理设计的过程设计（程序设计问题），包括给水水质和经过预处理后出来的水质。然后讨论针对四种杂质所做选择的处理选项（即单元操作）： Control of fouling-removal of turbidity and particulates 浑浊度和粒子的除垢控制 Control of scaling-removal of hardness and metals 硬度和金属的除氧化皮控制 Removal of organi

3、cs and microbiological impurities 有机物和微生物杂质的去除 Removal of microbial control agents 微生物防治因子的去除Pre-treatment options are summarized in Figure 4-1 at the end of the chapter.本章结尾处的图4-1中总结了预处理的可选方案。The final sections of the chapter discuss the importance of anion composition/concentration, pH, materials

4、of construction, and pretreatment system control.本章的最后讨论了阳离子的构成/深度、pH、组成材料以及预处理系统控制的重要性。This discussion is based on the description of these technologies presented in Chapter 11.这些讨论是建立在11章中出现的对这些技术的叙述基础之上的。4.2 PROCESS DESIGN OF PRETREATMENT预处理的过程设计Process design of the pretreatment system is the sp

5、ecification of the unit operations or process steps to treat the feed water. Typical information includes flow rates, temperatures, pressure, and composition of all streams. Detailed mechanical design of the equipment for a given unit operation or process step is beyond the scope of this Guide.预处理系统

6、的过程设计是对处理给水的单元操作或加工步骤的规范。典型信息包括流速、温度、压力以及所有水流的组合。为给出的单元操作或加工步骤的设备做详细的机械设计不在此指南范围内。The process design （programming issues） for a pretreatment system may include:预处理系统的过程设计（程序设计问题）可能包括：a） Required quantity and quality of the water from the final treatment process. 经过终处理程序出来的必须的水量和水质。b） Temperature con

7、straints on the water used in a pharmaceutical process and the approach to microbial control. 对用于制药工艺的水温和防治微生物所需的温度限制。c） The final treatment option that has been chosen, as this defines the required water quality leaving pre-treatment. 已经选定的终处理选项，这就规定了离开了预处理步骤所需达到的水质。d） Quality of the feed water tha

8、t is the input to the pretreatment system （water quality to be validated over a one year period）. 预处理系统的给水水质（验证水质需要一年以上的期限）e） Difference between input water quality and desired output water quality. The difference determines imprities that must be removed by the pretreatment system. The difference i

9、s determined by performing a material balance. Attention should be paid to impurities and minor components. 输入水水质和希望得到的输出水水质之间的差异。此差异确定了必须要用预处理系统去除的杂质。此差异是通过执行一个物料平衡来决定的。应当特别注意杂质和较小的组分。f） Pretreatment options to provide the desired removal of impurities considering other factors such as capabilities

10、 of the labor force, economics, waste disposal, environmental considerations, validation, and the available space and utilities.鉴于劳动力、经济、废物处理、环境因素、验证以及或用的空间和设施之类的因素，预处理选项要能理想地去除杂质。In addition to defining the options for removal of impurities, the approach taken to microbial control is an integral pa

11、rt of the process design of the pretreatment system. Considerations include:除了规定去除杂质这一项以外，用于防治微生物的途径也是预处理系统过程设计需要整合的部分。考虑包括：a） If the drinking quality water to the pretreatment system comes from a municipality in the United States, it will typically contain chlorine, or chloramines, as a microbial c

12、ontrol agent. In Europe, ozone is the more common microbial control agent. The concentration of the agent should be sufficient to protect the initial steps of the pretreatment. 如果预处理系统的饮用水是来源于美国市区，那么它都会含有用作微生物防治因子氯或氯胺。在欧洲，臭氧是最普遍的微生物防治因子。因子的浓度应当足够用来防护预处理的最初步骤。b） If the quantity of microbial control a

13、gent is insufficient, additional microbial control agent may be added or provision made to periodically sanitize the initial equipment in the pretreatment system. This is likely if water comes from a source other than a municipality. Increased monitoring of feed water and the initial steps may be wa

14、rranted. 如果微生物防治因子的量不够，那么可以添加额外的微生物防治因子或者在预处理系统的首个设备进行定期消毒。如果水是来源于市政以外，这种情况是很有可能的。希望能够保证增加对给水和最初步骤的监控。c） At some point in the pretreatment process, the microbial control agent must be removed before going to the final treatment. At this point, a means of either continuous or periodic sanitization ne

15、eds to be selected for the treatment steps following this removal. 在预处理过程的某些点上，进行终处理前必须去除微生物防治因子。在这种点上，必须为去除之后的步骤选择连续或定期消毒两种方式其中之一。The USP requirement that compedial waters should contain “no added substancd” eliminates addition of chemicals to Purified Water or Water For Injection. However, additio

16、n of chemical agents is not prohibited in pretreatment. Substances are frequently added in pretreatment and subsequently removed in the pretreatment or final treatment. Some examples are:USP规定法定水应当含有“非添加物质”，这就排除了向“纯化水”或注射用水中添加化学物质的可能性。但是，在预见处理中并不禁止添加化学助剂。预处理时经常会加入一些物质，而它们又会在预处理或终处理中被去除。比如： Chlorine

17、（to control microbial growth, removed in later stages of pretreatment） 氯（为了防治微生物生长，会在预处理的最后阶段去除） Sodium ions （in softener with exchange for multivalent ions, removed in ion removal process） 钠离子（在软化器中和多价离子进行交换，在去离子工序中被去除） Acid （for degasification to remove carbon dioxide, counter ions, removed in a s

18、ubsequent ion removal process） 酸（为了脱除二氧化碳气、反离子，在随后的去离子工序中被去除） Sulfite （to reduce chlorine to chloride, or chloramihes, to ammonium and chloride while forming sulfate, removal by softening or ion removal process） 亚硫酸盐（在形成硫酸盐的同时将氯转化为氯化物，或者将氯胺转化为铵和氯化物，通过软化或去离子工序去除） Sequestrants （to prevent scaling in f

19、inal treatment, removed by RO in final treatment） 螯合剂（在终处理中防止结垢，通过终处理中的RO去除） pH control agents （removed in ion removal process） pH控制因子（在去离子工序中去除）Added substances are an issue if they result in an increase in microbial growth or endotoxins.如果添加的物质导致微生增长或内毒素增加，那么它们就是一个问题。A final consideration is the r

20、elationship between investment and operating dollars in pretreatment, and the performance and cost of the final treatment process. The following are generally true:最后需要考虑的是预处理的投资和开发费用与终处理工艺的性能和成本之间的关系。 A final treatment system will not operate reliably over the long term, without reliable operation

21、of the pretreatment system. 如果预处理系统操作性不可靠，那么终处理系统的长期操作也不会可靠。 Inadequate operation in pretreatment （breakthrough of particulates, hardness, or chlorine） may not immediately affect water quality from final treatment, but it will be reflected in long term maintenance and operating reliability, and poss

22、ibly in water quality. 预处理中操作不充分（有粒子、硬度或氯漏过）或能不会立即影响到终处理的水质，但是会反映在长期维护和操作可靠性上，也有可能是水质。 Investment in pretreatment capability and reliability can return many times the investment in final treatment maintenance costs. 在预处理能力和可靠程度上的投资得到的回馈会是花费的终处理维护上的几倍。 Pharmaceutical water systems are expected to gen

23、erate water meeting final pharmaceutical product water standards. The system should be designed to control impurity spikes in the incoming water quality, or seasonal impurity profile changes. A robust pretreatment system design handles impurity spikes detrimental to final treatment. 我们期望制药用水系统生成的水能够

24、达到最终药品的水质标准。设计系统时应当控制给水水质中的杂质峰，或者杂质表现出的周期性变化。设计一个坚固耐用的预处理系统来处理那些终处理不易去除的杂质峰。There is no single right answer to the process design of the pretreatment system. Pretreatment system process design is a series of choices and options, each with advantages and disadvantages.预处理系统的过程设计并没有唯一的“正确”答案。预处理系统的过程设

25、计是一系统的选择，每个都有各自的利弊。4.3 FEEDWATER TO PRETREATMENT QUALITY: TESTING AND DOCUMENTATION预处理给水水质：测试和文件记录Compendial pharmaceutical water systems are required to use feed water complying with Drinking Water standards.法定的药用给水系统应当用符合“饮用水”标准的给水。Most pharmaceutical manufacturers utilize municipal water supplies

26、. This water generally meets quality standards and is treated with a microbial control agent. Historically in the US, the microbial control agent is chlorine, but chloramine is now used with increasing frequency. Either feed water composition or microbial control agent concentration may be subject t

27、o occasional and seasonal variations. These variations may negatively impact water quality, and can be detected only by extensive sampling. In addition, water quality at the plant site may not be equivalent to that from a municipal treatment facility, due to potential for contamination or loss of mi

28、crobial control agent in the distribution system. Documentation of feed water quality is recommended either by use of municipality testing （if applicable） supplemented by some testing atthe plant side or by extensive testing of feed water quality.大多数的药品制造商都是使用的市政供水。这个水一般都满足“饮用水”的质量标准，并用微生物防治因子处理过。在美

29、国历史上，微生物防治因子是氯、但是现在使用氯胺的频率也在增加。给水成份或微生物防治因子的浓度都会受偶然因素或季节变化的影响。这种变化对水质会有不利影响，而且只有用扩大抽样才能检查出来。此外，在工厂里的水质也有可能和市政处理厂出来的不一样，这是因为在分配系统中微生物防治因子在污染或丢失的可能性。给水的水质文件推荐用市政测试结果（如果适用的话），再补充一些在工厂里所做的测试结果，也可以对给水水质做全面的测试。Typical contaminants in feed water include:给水中含有的典型成分有： Particulates Silt, dust, pollen, pipe scale, iron and silica, undissolved minerals and organics 粒子 泥沙、灰尘、花粉、管垢、铁和二氧化硅、不溶的矿物质和有机物 Inorganics Calcium and magnesium salts, heavy metals （iron, aluminum, and silica） with their corresponding anions