| 黄家乐,王玥,何睿,裘畅,董铸雄.无菌预灌装培养平皿的质量控制[J].中国药事,2017,(10):1147-1152 |
| 无菌预灌装培养平皿的质量控制 |
| Quality Control of Aseptic Pre-filling Agar Plates |
| 投稿时间：2017-03-07 |
| DOI：10.16153/j.1002-7777.2017.10.009 |
| 中文关键词: 无菌药品生产 质量控制 无菌预灌装培养平皿 培养基适用性 透气呼吸袋 物料传递 |
| 英文关键词: sterile drug production quality control aseptic pre-filling agar plates medium suitability test breathable air bag material transfer |
| 基金项目: |
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| 摘要点击次数: 1023 |
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| 中文摘要: |
| 目的：通过对比3家不同供应商的无菌预灌装培养平皿实验结果，筛选出质量较好的平皿培养基，同时探讨其供应商筛选、进厂检查和使用方法，为无菌药品生产企业进行无菌预灌装培养平皿的质量控制工作提供参考。方法：分别对3家供应商的无菌预灌装培养平皿进行3个批次的模拟使用，培养基无菌性、内层包装袋无菌性、平皿密闭性和培养基适用性检查，筛选适合用于无菌生产区洁净环境微生物监测的平皿培养基。结果：3家供应商的模拟使用、培养基无菌性和内层包装袋无菌性实验结果没有差异，供应商A的平皿密闭性和培养基适用性实验结果较另外两家更好。结论：本实验方法可用于筛选质量较好的无菌预灌装培养平皿。 |
| 英文摘要: |
| Objective: By comparing the tests results from three different suppliers, the aseptic pre-filling agar plate with better quality was chosen. Meanwhile, the selection of suppliers, entry inspection and application of the plates were discussed so as to provide references for quality control of the aseptic pre-filling agar plates for sterile pharmaceutical manufacturers. Methods: Medium aseptic test, inner packaging bag aseptic test, plate seal test and medium suitability test were carried out by simulated use of three different batches of the aseptic pre-filling agar plates of three suppliers so as choose suitable one for clean environmental microorganism monitoring in sterile production areas. Results: There were no differences in the results of simulated use of three suppliers, including the medium aseptic test and the inner packaging bag aseptic test. However, the results of the plate seal test and medium suitability test of supplier A were better than those of other two suppliers. Conclusion: This experimental method could be used to screen for better aseptic pre-filling agar plates. |
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