新型冠状病毒灭活疫苗（vero细胞）无菌分装工艺验证

田盛举 张颖聪 杨雯娜 陈坚 刘晨鸣 刘晓凡 谢澎

doi:10.3760/cma.j.cn 311962-20210927-00056

国际生物制品学杂志 >

2021 , Vol. 44 >Issue 6: 310 - 314

DOI: https://doi.org/10.3760/cma.j.cn 311962-20210927-00056

新型冠状病毒灭活疫苗（vero细胞）无菌分装工艺验证

田盛举张颖聪杨雯娜陈坚刘晨鸣刘晓凡谢澎

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¹兰州生物制品研究所有限责任公司质量保证部 730046； ²兰州生物制品研究所有限责任公司生产管理部 730046

网络出版日期: 2025-08-16

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Sterile filling process validation of the COVID-19 inactivated vaccine(Vero cell)

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¹Department of Quality Assurance, Lanzhou Institute of Biological Products Co., Ltd., Lanzhou 730046, China; ²Department of Production Management, Lanzhou Institute of Biological Products Co., Ltd., Lanzhou 730046, China

Online published: 2025-08-16

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摘要

目的评价新型冠状病毒灭活疫苗（Vero细胞）无菌分装工艺过程，确保疫苗安全性。方法根据质量风险管理原则，运用失败模式和效果分析的风险管理工具评估影响新型冠状病毒灭活疫苗（Vero细胞）分装过程无菌的潜在风险。用胰酪大豆胨液体培养基为介质，模拟新型冠状病毒灭活疫苗（Vero细胞）半成品的无菌分装工艺过程，从最差条件的选择、模拟干预动作的设计、模拟分装试验品培养、促生长试验、完整性试验5个方面设计基于风险评估的无菌分装工艺模拟试验方案，进行连续3次成功的培养基模拟灌装试验。结果连续3次试验培养基污染瓶数为0；各项检测试验结果均符合可接受标准。结论新型冠状病毒灭活疫苗（Vero细胞）分装工艺满足法规对产品无菌性的要求，无菌风险可控，可用于新型冠状病毒灭活疫苗（Vero细胞）半成品的分装。

关键词： 新型冠状病毒灭活疫苗（Vero细胞）；无菌分装；工艺验证；培养基灌装试验；风险评估

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田盛举张颖聪杨雯娜陈坚刘晨鸣刘晓凡谢澎 . 新型冠状病毒灭活疫苗（vero细胞）无菌分装工艺验证[J]. 国际生物制品学杂志, 2021 , 44(6) : 310 -314 . DOI: 10.3760/cma.j.cn 311962-20210927-00056

Abstract

Objective To validate the sterile filling process and ensure the safety of the COVID-19 inactivated vaccine(Vero cell). Methods Based on the principles of quality risk management, the tools of failure mode effects analysis were applied to evaluate the potential risks affecting the sterility during vaccine filling process. The filling process of COVID-19 inactivated vaccine(Vero cell) bulk was simulated using typtone soy broth medium. The implement was desiged from 5 aspects, the worst condition, intervention action, incubation test, media growth promotion test and integrity test. Three consecutive batchs of successful media fill test were performed with tryptone soy broth medium. Results None of the bottles was contaminated after the incubation. All the test results met the acceptable standards. Conclusion The validation demonstrated the filling process of COVID-19 vaccine is established and met the regulation, the asepsis risk is under controll.

Key words： COVID-19 vaccine(Vero cell), inactivated; Asepsis process simulation; Media fill test; Risk assessment

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