清洁验证之分析方法-上(中英文版)（PDA TR 49内容节选6）
6.0 Analytical Methods分析方法
It is essential to a cleaning validation program that the appropriate analytical methods are utilized.
一个清洁验证程序使用适当的分析方法是非常必要的。
Analytical methods must be appropriate in that they can adequately detect the residue(s) of concern.分析方法必须适当，能充分检测到相关残留物。
It is also important to understand what can be concluded from the analytical result (e.g., was the productnot removed or was the cleaning agent not removed?).
对能从分析结果中推断出什么的理解也是非常重要的（比如：产品没有被去除或清洗剂没有被去除？） 。
The results of testing will determine if the cleaning validation cycle is acceptable or if it needs
to beredeveloped.
检测结果将决定清洁验证周期是否接受或者是否需要重新开发。
Thus, it is important to have confidence in the results.
因此，对结果的信任是非常重要的。
This section discusses how to select the appropriate assay methods, detailed information on theapplicability and use of nonspecific assays and microbial test methods,and assay method validation.
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本部分讨论怎样选择合适的分析方法及其适用性的详细信息，非特定分析和微生物测试方法的使用，和分析方法验证。本部分套乱怎样选择合适的含量分析方法，实用性的详细信息，非特定含量方法和微生物测试方法以及含量方法验证。
6.1 Specific Analytical Methods
6.1 特定分析方法
Specific analytical methods are those which measure a certain residue in the presence of expectedinterferences.
特定分析方法是指用于测量存在预期干扰时某个残留的方法。
In a cleaning process for biotechnology products where the specific analyte is the active protein, suchinterferences may include degradation products and related substances, excipients, cleaning agents andcleaning agent by-products.
在生物技术产品的清洗过程中，特定分析物是活性蛋白，这样干扰可能包括降解产品和相关物质，辅料，清洗剂和产品清洗剂。
Examples of specific methods include HPLC, ELISA,SDS PAGE, and PCR.
特定方法的例子包括 HPLC,ELISA,SDSPAGE,和 PCREach
of these methods requires the use of an appropriate reference standard.
这些方法每个都需要使用一个适当参考标准。
In contrast, nonspecific analytical methods measure a general property, such as conductivity orTOC,which could be due to a variety of analytes or sources.
相对而言， 非特定分析方法测量通用属性， 比如：电导率或者 TOC， 因为分析物或者来源的多样性。
Selection of an analytical method will depend on the nature of the residue as it exists after the cleaningprocess.
一个分析方法的选择将取决于清洁过后残留物的性质。
Only if a protein (or other organic active) is not degraded during the cleaning process (surviving hightemperatures and pH extremes in an aqueous environment, for example) does it make sense to use a specific analytical method for that active.
只有当一种蛋白质（或者其他有机活性物质）在清洁过程中不能被降解（例如：在高温和极端 PH 的水环境下残存） ，使用那种物质的特定分析方法才有意义。
The advantage of using a specific analytical method in this situation is that it gives a precise measure ofthe major residue of concern – the active itself.
在这种情况下使用特定分析方法的优势是它可以给出主要相关残留--活性物本身的精确测量。
If a specific analytical method for an active protein were utilized following a cleaning process which hasbeen demonstrated to denature (degrade) that active protein, it is likely that residues of the activeprotein would be non-detectable (i.e., not measurable) by that specific analytical method.
如果一个活性蛋白质的特定分析方法在紧接着的清洁过程中被使用，这个清洁过程用来证明降解（变性）这个活性蛋白质。这个活性蛋白残留通过这个特定分析方法将很可能检测不到（不能被检测） 。
Residues of that protein would be various degraded fragments.
那个蛋白质的残留可能讲解成多种片段。
If the native protein were actually detected using a specific method for that protein, it is likely that therehad been a serious problem with the cleaning process, such as a clogged spray device causing a lack ofcoverage of that portion of the equipment surface.
如果天然的蛋白质真的用特定方法被检测到，那么清洁过程很有可能有一系列的问题，比如堵塞喷淋设备引起的设备表面喷淋覆盖不全面。
In such a case, failure would also most likely be detected by a nonspecific method and/or by visualexamination.
在这种情况下，失败也可以通过非特定方法或目视检察被检测到。
Consequently, if a specific assay method is used, a nonspecific assay method is also required, unlessstudies prove that the product is not degraded by the cleaning process.
因此，如果一个特定的含量分析方法被使用，一个非特定的分析方法也是需要的，除非研究证明清洗过程中产品没有被分解。
In biotechnology cleaning validation, specific analytical techniques such as HPLC are more likely to beused for detergents, because the surfactants or other functional materials in the detergents are not likelyto degrade in the cleaning process.
在生物技术清洁验证中，特定分析技术比如 HPLC 更倾向用于清洗剂的检测，因为表面活性剂或者清洁剂中的功能材料在清洁过程中不可能分解。
However, it should be noted that nonspecific methods can also be used for detergents and other cleaningagents.
无论怎样，必须注意非特定方法也可以用于洗涤剂或者其他清洁剂
6.2 Impact of Inactivation/Degradation of the Active
6.2 活性物质的降解/ 灭活的影响
Product inactivation means that the active protein is modified in some way such that it is no longer activeand may no longer be measurable by specific analytical methods for that native protein.
产品灭活意味着活性蛋白被某些方式改变，这样这些蛋白不再有活性和不再被这种天然蛋白质的特定分析方法测量到。

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