poorlittle
第4楼2011/03/07
For your information:
(from http://bbs.foodmate.net/archiver/tid-76940.html )
标准的做法是采用培养基灌注试验(media fill),在ISO13408-1中对灌注条件和方法进行了详细的描述。
(from http://yanjp.w2.leoboard.com/cgi-bin/printpage.cgi?forum=7&topic=428 )
42. Validation of aseptic processing should include a process simulation test using a nutrient medium (media fill).
无菌生产过程的验证,要包括利用营养培养基进行的模拟试验。
poorlittle
第6楼2011/03/07
By searching with Google using the keywords “media fill run, 药”
By the way, there is a relevant paper at http://www.iptonline.com/articles/public/IPT_17_2005_p90_92x.pdf