| 张萌萌,莫伟娜,栾园园,马延兴,郝树彬.传统型血袋无菌检测新技术研究[J].中国药事,2022,36(2):154-160 |
| 传统型血袋无菌检测新技术研究 |
| Study on New Technology for Sterility Test of Traditional Blood Bags |
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| DOI：10.16153/j.1002-7777.2022.02.007 |
| 中文关键词: 传统型血袋 无菌检查 方法适用性 薄膜过滤法 培养基冲洗法 培养基灌装法 |
| 英文关键词: traditional blood bags sterility test method applicability membrane filtration method medium flushing method medium filling method |
| 基金项目: |
| 作者 | 单位 | | 张萌萌 | 山东省医疗器械和药品包装检验研究院,国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,济南 250101 | | 莫伟娜 | 山东省医疗器械和药品包装检验研究院,国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,济南 250101 | | 栾园园 | 山东省医疗器械和药品包装检验研究院,国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,济南 250101 | | 马延兴 | 山东省医疗器械和药品包装检验研究院,国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,济南 250101 | | 郝树彬 | 山东省医疗器械和药品包装检验研究院,国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,济南 250101 |
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| 中文摘要: |
| 目的： 建立传统型血袋无菌检查新方法。方法：以传统型血袋为研究对象，采用“培养基冲洗法”“培养基灌装法” 2种新的无菌检查方法和传统薄膜过滤法进行方法适用性试验，以确定所设计方法对该产品的适用性；另选取萎缩芽孢杆菌(ATCC 9372)作为代表性菌株污染血袋，选取4个稀释梯度，进行3种方法的检出率对比研究以得到最优的无菌检查方法。结果：方法适用性试验中试验菌均生长良好；3种不同方法中培养基灌装法检出率最高，其次为培养基冲洗法，均优于传统的薄膜过滤法。 结论：3种方法均适用于传统型血袋产品的无菌检查；但培养基灌装法检出率高且降低了假阳性概率及试验操作成本，为传统型血袋无菌检验的首选方法。若存在产品材质影响结果观察等情况，可选择培养基冲洗法进行该类产品的无菌检验。 |
| 英文摘要: |
| Objective: To establish a new method for sterility test of traditional blood bags. Methods: Taking traditional blood bags as the research object, and the two new sterility test methods of "medium flushing method", "medium filling method" and the traditional membrane filtration method were carried out to determine the applicability of the designed method to the product. Bacillus atrophicus (ATCC 9372) was selected as the representative strain to contaminate the blood bag, and four different dilution gradients were selected to conduct comparative study on the detection rates of the three methods, so as to obtain the optimal sterility test method. Results: All the bacteria grew well in the applicability test; among the three methods, the medium filling method had the highest detection rate, followed by the medium flushing method, which were superior to the traditional membrane filtration method. Conclusion: The three methods are suitable for sterility test of traditional blood bags. However, the medium filling method has a high detection rate and reduces the false positive probability and the operating cost of the test, so it is the preferred method for the sterility test of traditional blood bags. When the material of the product affects the observation of the results, the medium flushing method could be chosen to conduct the sterility test of such products. |
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