金币
UID176556
帖子
主题
积分25288
注册时间2014-6-6
最后登录1970-1-1
听众
性别保密
|
楼主 |
发表于 2016-12-12 21:50:53
|
显示全部楼层
本帖最后由 beiwei5du 于 2016-12-12 21:56 编辑
非也！在grab rinse sampling的情况下，只能是先rinse sampling，而后才能swab sampling.我上一家公司就是这种（而且是很pragmatic的方式，该清洗系统是效仿国外很大的CMO原料厂商的）。而对于separate rinse sampling方式在这两份memo中有提到：
The first situation involves the situation where my rinse sample is a grab sample of thefinal process rinse, and then my swab samples are taken after completion of that processrinse and any subsequent drying of equipment surfaces. In that case, the “rinse sample” isnot sampling the residues on equipment surfaces after completion of the process rinse(remember that for swab sampling I am measuring residues on surfaces after completionof the process rinse). If I am using a series of pulse rinses, then the final pulse rinse ismeasuring residues on surfaces left after the penultimate (that is, next to last) pulse rinse.So realistically, I am not comparing sampling of the same situation in this case. Now, Istill might expect that swab sampling is more likely to give me a failing result, because inthat grab sample of the process rinse, I am effectively integrating residue results over all rinsed surfaces. But, I am more open to the rinse sampling results being the more criticalmeasurement, because I realize that what I am sampling with a grab sample is a worstcase as compared to a separate sampling rinse, that is, a sampling rinse after thecompletion of the process rinse.
The second situation is where I am performing a separate sampling rinse after the finalprocess rinse is completed. There is also a difficulty in comparing swab and rinse resultsin this situation. Let’s say I first perform swab sampling, and then perform a separatesampling rinse. If I have sampled my worst case locations (and presumably removed alarge portion of residues from those sampled sites), won’t this alter any rinse sampling Imight subsequently do. That would be a situation where I might expect a greaterpossibility that rinse would pass, while at least some swab samples might fail. But what ifI reverse the order and perform my separate sampling rinse first, and then follow that upwith swab sampling for the worst case locations. What I have effectively done is reducedany residues on those locations to be swabbed by performing my separate sampling rinsebefore I actually swabbed the surfaces.
Note that in the latter case, not only can I not compare rinse and swab results, but Ishould not perform the swab sampling after the separate sampling rinse because the swabresults will appear cleaner. In the former case it is acceptable to perform swabbing after agrab rinse sample of the process rinse, because in that case the rinse sample I collect willprovide the same or a worst case result as compared to a separate sampling rinse.
Note that I am not making a case that one type of sampling is inherently better (or worse)than another. The point is that rinse and swab measure different things about a givenresidue on equipment surfaces, and I should not expect some kind of direct correlation ofthe two.
需要注意的是“same scenario/situation”的理解！
|
|
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2016-12-11 23:58:41
置顶卡
变色卡
