制药企业清洁验证与清洁确认中的取样方法的选择

6.1Sampling Method Selection

取样方法的选择

Selectionof a sampling method depends on the nature of the equipment, the nature of theresidue being measured, the residue limit, and the desired analyticalmethod.Sampling methods discussed here are:

取样方法的选择取决于设备、待检测残留物的性质，残留物限度以及所需的分析方法。这里讨论的取样方法包括：

·Direct surface sampling

直接表面取样

·Rinse sampling

冲洗取样

·Swabbing

擦拭法

·Placebo sampling.

安慰剂取样法

 

Itshould be noted that while regulatory documents refer to swabbing as “direct”sampling and to rinse sampling as “indirect” sampling, it is operationally moredescriptive to refer to those sampling methods as “swab sampling” and “rinsesampling,” and reserve the term “direct sampling”for techniques such as visual inspection.

需要注意的是，虽然相关规范性文件将擦拭法称为“直接”取样方法，冲洗法称为“间接”取样方法，但更具有可操作性的描述是将这些取样方法称为“擦拭取样”以及“冲洗取样”，而对于目检等技术则保留了“直接取样”的术语。

Swab/wipesampling, rinse sampling, and visual examination are listed as acceptablesampling techniques in most regulatory documents (20, 21, 22).Each method has its advantages and limitations. In a given protocol,multiple sampling methods may be used, such as “both rinse sampling and visualexamination” or “rinse sampling, swab sampling, and visual examination,” asrequired to adequately determine that the equipment is acceptably clean.

在大多数法规文件（20,21,22）中，擦拭法，冲洗法以及目检都是可以接受的取样方法。这些方法有其它们自身的优点与局限。在一个给定的验证方案中，为了充分确认设备清洁是可接受的，可以采用多种取样方法，例如“冲洗取样与目检结合”或者“冲洗取样，擦拭取样以及目检相结合” 。