Conclusion Sterilitytestmedium manufacturers should be put in production license system.
结论应实行无菌试验培养基生产企业生产许可证制度。
2
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.
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。
3
In the case of validation, recovery, toxicity of the dilution medium and sterility (negative test) are examined to guarantee the suitability of the test in the presence of the product.