包材密封性微生物挑战法实验方案探讨

doi:10.19803/j.1672-8629.20220395

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (11): 1181-1185.
DOI: 10.19803/j.1672-8629.20220395

• 生物模型方法在药品安全研究中的应用专栏 • 上一篇下一篇

包材密封性微生物挑战法实验方案探讨

史春辉¹, 尹翔¹, 张肖宁^1,*, 王威^2Δ, 于嘉伟³, 姚尚辰^4#, 许明哲⁴

¹黑龙江省药品检验研究院生物安全检验研究所,黑龙江哈尔滨 150080;
²哈药集团制药总厂,黑龙江哈尔滨 150000;
³东北林业大学,黑龙江哈尔滨 150040;
⁴中国食品药品检定研究院,北京 102629

收稿日期:2022-07-11 发布日期:2022-11-17
通讯作者: ^*张肖宁,女,博士,副主任药师·博导,药品、医疗器械、药包材、化妆品、保健食品检验及科研。E-mail: zhangxiaoning761204@126.com;^#为共同通信作者。
作者简介:史春辉,男,硕士,主管药师,药品检验和药物分析。^Δ为并列第一作者。
基金资助:
国家重点研发计划（SQ2022YFC3400054）

Discussion on the experimental scheme of microbial challenge method of sealing of packaging materials

SHI Chunhui¹, YIN Xiang¹, ZHANG Xiaoning^1,*, WANG Wei^2Δ, YU Jiawei³, YAO Shangchen^4#, XU Mingzhe⁴

¹Institute of Biosafety Inspection, Heilongjiang Institute of Drug Inspection, Harbin Heilongjiang 150080, China;
²Harbin Pharmaceutical Group Pharmaceutical General Factory, Harbin Heilongjiang 150000, China;
³Northeast Forestry University, Harbin Heilongjiang 150040, China;
⁴Institute for Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China

Received:2022-07-11 Published:2022-11-17

摘要/Abstract

摘要： 目的探讨包材密封性微生物挑战法的实验方案,为保证无菌药品在其全生命周期范围内的安全性提供参考。方法采用微生物菌悬液浸泡法,选用不同的包装系统、不同的浸泡菌株、不同的浸泡条件等关键性因素进行相应试验,对微生物挑战法的具体细节进行探索性研究。结果本研究确定了微生物侵入实验的阳性样品制备、样品数量选择、挑战微生物选择、侵入浓度及微生物侵入条件的选择等关键参数,并选取合适方案对不同包装系统进行微生物挑战实验,结果均符合各法规相应要求。微生物侵入的关键孔径集中在3~5μm,此孔径包装系统在日常储存和运输中存在污染的风险。结论制药企业应结合实际情况,将物理法和微生物挑战法进行有效关联,以保证药品在全生命周期的无菌性。

关键词: 包材, 密封性, 微生物菌悬液浸泡法, 微生物侵入关键参数

Abstract: Objective To discuss the experimental scheme of microbial challenge method of sealing of packaging materials, so as to provide reference for ensuring the safety of sterile drugs in the whole life cycle. Methods The microbial suspension immersion method was adopted, and the key factors such as different packaging systems, different soaking strains and different soaking conditions were selected for corresponding experiments to explore the specific details of the microbial challenge method. Results This study determined the key parameters such as the preparation of positive samples, the selection of sample quantity, the selection of challenging microorganisms, the invasion concentration and the selection of microbial invasion conditions for the microbial invasion experiment, and selected the appropriate scheme to carry out the microbial challenge experiment on different packaging systems. The results met the corresponding requirements of various laws and regulations. The key pore size of microbial invasion is concentrated in 3-5μm,packaging systems with these apertures have the risk of contamination during daily storage and transportation. Conclusion Pharmaceutical enterprises should combine the actual situation,the physical method and the microbial challenge method should be effectively linked to ensure the sterility of the drug in the whole life cycle

Key words: packaging materials, seal, microbial suspension immersion method, key parameters of microbial invasion

中图分类号:

R955

史春辉, 尹翔, 张肖宁, 王威, 于嘉伟, 姚尚辰, 许明哲. 包材密封性微生物挑战法实验方案探讨[J]. 中国药物警戒, 2022, 19(11): 1181-1185.

SHI Chunhui, YIN Xiang, ZHANG Xiaoning, WANG Wei, YU Jiawei, YAO Shangchen, XU Mingzhe. Discussion on the experimental scheme of microbial challenge method of sealing of packaging materials[J]. Chinese Journal of Pharmacovigilance, 2022, 19(11): 1181-1185.

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包材密封性微生物挑战法实验方案探讨

Discussion on the experimental scheme of microbial challenge method of sealing of packaging materials

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