| 柯志鸿,饶小平,周承芳,韩恵强,陈锦珊.两种除菌级疏水性过滤器完整性测试方法的比较[J].中国药事,2018,32(9):1207-1210 |
| 两种除菌级疏水性过滤器完整性测试方法的比较 |
| Comparison of Integrity Test Method of Two Sterilization Level Hydrophobic Filters |
| 投稿时间：2017-09-19 |
| DOI：10.16153/j.1002-7777.2018.09.008 |
| 中文关键词: 无菌制剂 药品生产 疏水性过滤器 完整性测试 起泡点测试法 水侵入测试法 除菌过滤 |
| 英文关键词: sterile preparations pharmaceutical production hydrophobic filter integrity test bubble point test water intrusion test aseptic filtration |
| 基金项目: |
| 作者 | 单位 | E-mail | | 柯志鸿 | 解放军第一七五医院, 厦门大学附属东南医院, 漳州 363000 | | | 饶小平 | 解放军第一七五医院, 厦门大学附属东南医院, 漳州 363000 | | | 周承芳 | 解放军第一七五医院, 厦门大学附属东南医院, 漳州 363000 | | | 韩恵强 | 解放军第一七五医院, 厦门大学附属东南医院, 漳州 363000 | | | 陈锦珊 | 解放军第一七五医院, 厦门大学附属东南医院, 漳州 363000 | cjs1223@souhu.com |
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| 中文摘要: |
| 目的：比较两种除菌级疏水性过滤器完整性测试方法，提出适用性的建议及需要把握的要点，旨在为同行开展此类工作提供参考。方法：阐述无菌制剂生产过程中除菌级过滤器的法规要求，较全面地比较起泡点测试法与水侵入测试法的基本原理、影响因素及其在应用中的优劣性。结果：两种方法基于相同测试原理，适用限制条件略有不同，均能有效保证除菌过滤系统的完整性，降低制药质量风险。结论：水侵入测试法不需要引入有机溶剂等低表面张力溶液进行润湿，操作简便，更适宜于医院无菌制剂生产过程除菌级疏水性过滤器的完整性测试。 |
| 英文摘要: |
| Objective: To compare integrity test method of two sterilization level hydrophobic filters, to put forward suggestions for their applicability and the key points to be grasped in order to provide references for peers to carry out similar work.Methods: The regulatory requirements for sterilization level filters used in the process of sterile preparations were discussed. The basic principles, influencing factors, as well as advantages and disadvantages of the bubble point test and water intrusion test were compared.Results: The two methods were based on the same test principle. The applicable restriction conditions were slightly different. Both methods can effectively guarantee the integrity of the sterilizing filtration system and reduce the pharmaceutical quality risk.Conclusion: The water intrusion test does not require the introduction of the organic solvent or other lowsurface-tension solvents for wetting. As a result, it is easy to be carried out and more suitable for the integrity test of the sterilization level hydrophobic filters used in the production process of the sterile preparations in hospitals. |
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