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.
结果与结论细胞因子类制品不同的品种和剂型可以采用不同的无菌检查法,并对新建立的无菌检查法进行方法学验证。
Results and Conclusion Different varieties and formulations of cytokines could apply dissimilar methods in sterile test. Methodology validations were performed for these new established tests.
结果与结论细胞因子类制品不同的品种和剂型可以采用不同的无菌检查法,并对新建立的无菌检查法进行方法学验证。
Results and Conclusion Different varieties and formulations of cytokines could apply dissimilar methods in sterile test. Methodology validations were performed for these new established tests.
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