制药企业清洁验证和清洁确认取样方法之微生物以及内毒素分析取样

6.3Sampling for Microbial and Endotoxin Analysis

微生物以及内毒素分析取样

Samplingfor bioburden may involve rinse-water sampling and/or swabbing, but may alsoinvolve contact plates. Consideration should be givento the sampling solution for swabbing and rinsing. For swabbing, a sterilesolution, such as phosphate-buffered saline, should be used. For rinsesampling, it is generally not practical to sample large equipment items withsterile water; however, for extraction of small parts, the use of sterile wateror a sterile solution is preferred. For large equipment, rinse sampling isgenerally done with purified water or WFI, and results may be compared to ablank taken from the same use point. Rinse-water sampling for bioburden shouldinvolve use of sterile sample containers. “Aseptic” sampling technique, muchlike is used for cleanroom bioburden sampling, is required for any microbialmethod to avoid external contamination of the sample.

生物负载取样可采用冲洗和/或擦拭法，也可包括接触碟法。应关注擦拭法以及冲洗法中的样品溶液。对于擦拭法，应采用无菌溶液，如磷酸盐缓冲液。对于冲洗法，用无菌水对大型设备进行取样一般是不现实的。然而，对于小部件的提取取样，首选使用无菌水或无菌溶液。对于大型设备，一般选用纯化水或注射用水进行冲洗取样，结果需与同一用水点所取空白对照进行比较。生物负载的冲洗水取样应使用无菌取样容器。为了避免对样品的污染，同洁净室生物负载取样相同，任何微生物取样都需要采用无菌技术。

 

Samplingfor endotoxin is almost always a rinse water sample, preferably with low endotoxinwater.

内毒素取样几乎就是冲洗水样，最好采用内毒素含量低的水。