棉签擦拭微生物残留回收率之问题说

哈尔滨-HR

奥星检查的老师讲棉签擦拭微生物残留测试需要做棉签擦拭回收率试验，我们有些疑问也，以前有查询相关资料并无要求，论坛的老师们谁能给解疑下，到底怎样做才对呢？

隐月

TR29
6.5.5 Recovery for Bioburden and Endotoxin Sampling
生物负载以及内毒素取样回收率

Recovery studies to determine percentage recovery from surfaces are not appropriate and are not
normallydone for microbiological sampling. One reason for this is the question of enumeration in
microbiologicaltests – “colony forming units” are typically counted as opposed to individual organisms.A
second reason for this is that vegetative organisms will die or lose viability when dried on a couponin a
standard sampling recovery procedure. A third reason is that it is unclear which species should beused for a
recovery study. A fourth reason is that typically the limits set for bioburden are significantlybelow what
could possibly cause either product quality issues orprocess performance (e.g., SIP) issues;therefore, even
though recovery may be low (<50%), product quality and/or process performanceis not impacted by not
including a recovery factor
对于微生物取样，不适合进行回收率研究以确定表面百分回收率。原因之一是微生物检测的计数问
题&#8722;通常以“菌落形成单位”进行计数而不是单个微生物。第二个原因是在一个标准的取样回收率研究
中，当材质试样晾干时微生物会死亡或失去生存能力。第三个原因是不清楚选用哪种微生物进行回
收率研究。第四个原因是通常生物负载限度已明显低于可能影响产品质量或工艺性能（如在线灭菌）
的水平。因此，即使回收率低（<50%），不引入回收因子也不会影响产品质量和/或工艺性能。

Endotoxin recovery studies from surfaces using the sampling method are not ordinarily performed.One
reason is related to the low levels that are typically present on cleaned surfaces. Additionally, onlystandard
endotoxin from LAL test kit suppliers can be used for recovery studies and these may not beindicative
regarding detection and/or removal of endogenic endotoxins present from a manufacturingprocess. Finally,
the largest quantity of endotoxin present in a manufacturing vessel typically isendotoxin within a soil
matrix. The cleaning process itself is very effective in physically removing thisendotoxin along with other
manufacturing soils.
通常不进行取样表面内毒素的回收率研究。原因之一是洁净表面的内毒素水平通常较低。此外，只
有鲎试剂供应商提供的标准内毒素才可以用于回收率研究，但这些研究无法指示生产过程的内源性
内毒素的检测和/或去除情况。最后，生产容器中内毒素大多存在于污物中。清洁操作本身可以有效
清除这种内毒素以及其他污物。

韶光换

论坛上搜索PDA TR29

哈尔滨-HR

韶光换 发表于 2019-5-27 11:01
论坛上搜索PDA TR29

谢谢！

哈尔滨-HR

韶光换 发表于 2019-5-27 11:01
论坛上搜索PDA TR29

谢谢！

光头山鸡

PDA TR49 生物清洁验证，你可以具体了解下

郝小琴

TR 29 中提到"When using swab or rinse samples with a compendial analytical method, items that should be considered for suitability of use include the validated range, possible interferences from the cleaning process,possible interference from the swab, and recovery of residue from the swab (see Section 6.1.3)."，个人理解是需要的。

lov_new

综合来看，我的理解是拭子本身需要做回收率，而擦拭的操作不需要做回收率。

如果123

lov_new 发表于 2019-5-27 14:20
综合来看，我的理解是拭子本身需要做回收率，而擦拭的操作不需要做回收率。

支持,棉签是需要做回收率，微生物擦拭操作应该不用吧

liuchaons

微生物也做得，我们的范围50%-200%