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针对新版GMP无菌药品中关于沉降菌监测暴露时间的要求,验证了沉降碟在暴露4小时的情况下,其微生物促生长能力能够满足《中国药典》二部(2010年版)附录ⅪJ微生物限度检查法关于试验菌回收率不低于70%的要求。
In view of the requirement of monitoring the exposure time of sedimentation bacteria in the new GMP sterile drug, it was verified that the growth promoting ability of the sedimentation plate can meet the limit of microbial test of Appendix IIJ of the Chinese Pharmacopoeia (2010 edition) after being exposed for 4 hours. Law on the test bacteria recovery of not less than 70% of the requirements.