方法从当前药品无菌试验及高压灭菌存在的问题分析了两者对药品安全的重要性。
Methods From the problems of the current drug sterility testing and autoclave sterilized, analyze the importance of both for drug safety.
方法对骨髓源性神经干细胞的培养上清分别进行无菌试验、支原体检测、热原质检测和异常毒性试验。
Methods Sterility test, mycoplasma detection, pyrogen detection and abnormal toxicity test were performed respectively on culture supernatant of neural stem cells from bone marrow.
方法采用直接接种法,通过无菌验证试验确定无菌检查方法的有效性。
Conclusion The sterility test reassured by verification test is feasible and reliable.
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