PDA TR21 微生物负载回收率验证

罗伊鲱

21 - Bioburden Recovery Validation, 1990

墨石

中文英文的？

Sword

PDA TR29 2012 6.5.5

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 be used for a recovery study. A fourth reason is that typically the limits set for bioburden are significantly below 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 notincluding a recovery factor

不知道您对这一段是如何理解的？请指教。

Sword

不知道这个有最新版本吗，90年的文件太老了

gf00000520

没中文版吗，英语渣渣路过

syhorchid

学习一下

亦心

下载学习一下，谢谢楼主

亦心

居然不能复制，不过上面有一位也说了，PDA TR29里面对微生物回收率也做了说明

小金库

感谢分享。