Conclusion Sterility test medium 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。
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。
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.
如果需要确认和恢复,就要检测稀释培养基的毒性和无菌性(阴性测试)以确保该测试适用于现存药品。
应用推荐