清洁验证之取样方法PDA TR 49内容节选5 中英文版.docx

1、清洁验证之取样方法PDA TR 49内容节选5 中英文版清洁验证之取样方法（PDA TR 49内容节选5 中英文版）5.0 Sampling Methods 取样方法It is essential to a cleaning validation program that the appropriate sampling techniques are utilized.Sampling must be conducted with techniques appropriate for the equipment surfaces and for the natureof the study,

2、including the analytical methods used. This section discusses types of sampling methods,sampling recovery validation studies, and the training and qualification of samplers.在清洁消毒验证中采用适当的取样技术是必要的。取样过程中涉及的技术方法应与设备表面和研究本质相适应，包括使用的分析方法。这一部分讨论了取样方法的类型，验证取样回收研究以及取样人员的培训及资质。5.1 Sampling Method Selection取样方

3、法选择Selection of a sampling method depends on the nature of the equipment and the nature of the residue being measured. Sampling methods discussed here are direct surface sampling, swabbing, rinse watersampling and placebo sampling. It should be noted that while regulatory documents refer to swabbing

4、 as“direct” sampling and to rinse water sampling as “indirect” sampling, it is preferable and more descriptiveto refer to those sampling methods as “swab sampling” and “rinse sampling,” and reserve the term“direct sampling” for techniques such as the use of visual inspection.取样方法的选择取决于设备性质以及检测残留物的性质

5、。此处讨论的取样方法是直接表面取样，擦拭取样，冲洗水取样以及空白对照取样。值得注意的是法规文件中指出擦拭被认为是 “直接” 取样，冲洗水取样被认为是“间接”取样，所指的取样方法如“擦拭取样”和“冲洗水取样”是更可取并且更好被描述的，技术上保留“直接取样”的术语，比如使用目测检查。5.1.1 Direct Sampling Methods 直接取样方法Direct sampling methods (as used in this document) include visual inspection.直接取样方法（本文中使用的）包括目测检查。It is a well-accepted prac

6、tice that a cleaning process should remove visible residues from the productionprocess off of equipment surfaces. The visual inspection of equipment has limitations in that someequipment surfaces (e.g., piping) are usually not accessible for viewing. The use of optical equipment likemirrors or endos

7、copes, as well as the use of additional lighting, can help to facilitate visual inspection.清洁过程中应除去设备表面上来自于生产工艺可见残留，这一点是被广泛认可的。设备的目测检查具有局限性，因为一些设备表面（比如管道）通常是不易观察的。像镜子或者内视镜之类的光学仪器的使用作为辅助照明能够帮助进行目测检查。Remote inspection techniques (with fiber-optic probes and a LCD viewing screen) are utilized when visu

8、alinspection by a trained inspector is difficult to perform because of access to equipment surfaces, or whenone prefers to supplement an “unaided” visual inspection procedure.当由经过培训的人员由于要接触设备表面而难以进行目检时或者是补充 “未受协助” 的目检程序时，远程检查技术（纤维光学探头以及 LCD 观察屏）被应用。Borescopes, fiberscopes, and videoscopes allow visu

9、al inspection of hard-to-reach areas. Borescopes havebeen used to view the interior of piping and tank welds. Typical benefits of these scopes are that they:can fit into confined spaces not accessible to operators; are very maneuverable; have additional lightingattached; and may come with optional m

10、agnification and/or zooming capabilities. The major drawback ofthese scopes is the complexity of use, controlling lighting/brightness, and that the operator still has tomake the determination if the area viewed is visually clean.管道内窥镜，纤维内窥镜以及光纤视镜允许对难以达到的区域进行目检。管道内窥镜用于观察管道内部和水槽焊接点。这些范围的典型好处是：适用于操作人员接

11、触不到的密闭空间；易操作，具有辅助照明并且具有选择性放大和/或提升的能力。这些范围的最大缺点是使用复杂， 控制照明/亮度，并且操作人员需要判断该区域是否能够清晰可见。A remote visual camera allows operators to view remote areas on a screen. The camera has most of thesame strengths and weaknesses as the scopes, with the added benefit that operators can typically alsorecord video or

12、take pictures. Multiple operators can, at the same time, view what is on the screen. Thepotential to record video and allow multiple operators to view the screen may help support a sites visualinspection training program. Pictures printed from the camera may distort the actual amount of residueprese

13、nt, since operators will typically zoom in on a particular area when taking a picture.远程可视相机允许操作人员在屏幕上观察远程区域。相机与范围具有大部分相同的优势和劣势，而更多的优势是操作人员能够代表性的记录视频或者拍照。多个操作人员能够同时观察到屏幕显示了什么。记录视频以及允许多个观察者观察屏幕的可能性可以帮助支持厂区目检培训程序。来自相机的打印的图片可能扭曲残留的实际数量，因为操作人员将在特殊区域内聚焦，当拍照时。All these techniques, like visual inspection,

14、require an adequate training program.所有这些的技术，像是目检，要求具有充足的培训程序。5.1.2 Rinse Sampling冲洗取样Rinse sampling involves sampling the equipment by flowing water over all relevant equipment surfaces toremove residues, which are then measured in the rinse water. The most common rinse samplingtechnique is to take

15、 a grab sample from the final rinse water during the final rinse of the cleaning process.Another option is to fill the entire equipment with water after the cleaning procedure is completed. Then,a bulk sample is taken and analyzed. A third option is to utilize a separate CIP sampling rinse of define

16、dvolume following the completion of the final process rinse.冲洗取样涉及对设备取样通过流水冲洗所有相关设备表面移除残留，残留将在冲洗水中进行测量。大部分冲洗取样技术是在清洁过程中的最终冲洗中通过从最终冲洗水中提取随机样品。另一个选择是在完成清洁程序后，用水填满整个设备。然后，取大部分样品进行分析。第三个选择是使用单独的 CIP 取样冲洗定量，在最终冲洗完成后。Advantages and disadvantages of both methods for CIP rinsing are shown in Table 5.1.2.CIP 冲洗的两种方法的优势和劣势见表格 5.1.2Table 5.1.2 Comparison of CIP Grab Sampling versus Separate CIP Sampling Rinse表格 5.1.2 CIP 简单取样与单独 CIP 取样冲洗的比较Grab Sam