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.
当使用培养基直接接种法时，除非另有证据或授权，使用表2和3中显示的数量。
When using the technique of direct inoculation of media, use the quantities shown in Tables 2 and 3, unless otherwise justified and authorized.
如果膜过滤技术是不适合的，则使用在供试产品无菌检查法项下的培养基直接接种法。
If the membrane filtration technique is unsuitable, use the Direct Inoculation of the Culture Medium method under Test for Sterility of the Product to be Examined.
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