TECHNICAL STUDY ON INACTIVATING/REMOVING VIRUS IN COLLAGEN SPONGE_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

JIANG Lixia.

Shanghai Qisheng Biological Preparation Co., Ltd, Shanghai, 201106, P.R.China. Corresponding author: JIANG Lixia, E-mail: lixiajiang18@hotmail.com;

Corresponding author：

Keywords：

Collagen sponge; 60Co Radiation sterilization; Virus inactivating/removing; Bovine; Achilles tendon

DOI：

10.7507/1002-1892.20130194

Video：

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Objective To verify the technics of inactivating/removing virus in collagen sponge derived from bovine Achilles tendon. Methods Possible pathogen species were determined according to the raw material of bovine Achilles tendon used in production, then vesicular stomatitis virus (VSV), theiler’s mouse encephalomyelitis virus (TEMV), pseudorabies virus (PRV), and simian vacuolating virus 40 (SV40) were selected as indicator virus. Virus suspension was prepared in accordance with Technical Standard for Disinfection. 60Co radiation 25 kGy of collagen sponge was determined as inactivating/removing virus process according to the analysis of the manufacture process, the virus inactivation/removal effect was verified by the measurement of median tissue culture infective dose (TCID50) and showed by virus reduction factor (sample average values of numerical difference before and after processing). Results Reduction factors of VSV, TEMV, PRV, and SV40 after 60Co radiation 25 kGy were 5.646, 4.792, 5.042, and 5.292 logTCID50/0.1 mL (logs), respectively. Reduction factor of each indicator virus was greater than 4 logs, showing that 60Co irradiation 25 kGy can effectively inactivate and remove viruses. Conclusion 60Co radiation 25 kGy of collagen sponge derived from bovine Achilles tendon can be used as the technics of inactivating/removing virus during the preparation process of collagen sponge to guarantee the safety of the product.

Citation： JIANG Lixia.. TECHNICAL STUDY ON INACTIVATING/REMOVING VIRUS IN COLLAGEN SPONGE. Chinese Journal of Reparative and Reconstructive Surgery, 2013, 27(7): 885-888. doi: 10.7507/1002-1892.20130194 Copy

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16.	马平, 周锡鹏, 梅芳, 等. 胶原蛋白海绵生产中的病毒灭活工艺效果观察. 中国消毒学杂志, 2011, 28(3): 286-288.
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1. 由少华. 动物源原料医疗器械病毒和传染因子携带风险的监控. 中国医疗器械杂志, 2004, 28(5): 356-358.
2. 付海洋, 奚廷斐. 生物源性医疗器械的病毒安全性研究. 中国药物警戒, 2005, 2(2): 78-81.
3. 史新立, 谭芳奕, 王召旭, 等. 疯牛病病原体研究及动物源性医疗器械产品安全性思考. 中国修复重建外科杂志, 2006, 20(11): 1138-1144.
4. Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. WHO Technical Report Series, 2004: 924.
5. 国家食品药品监督管理局. 血液制品去除/灭活病毒技术方法及验证指导原则(国药监注[2002]160号). 2002.
6. Medical devices utilizing animal tissues and their derivatives. Part 1: Application of risk management. ISO 22442-1: 2007.
7. Medical devices utilizing animal tissues and their derivatives. Part 2: Controls on sourcing, collection and handing. ISO22442-2: 2007.
8. Medical devices utilizing animal tissues and their derivatives. Part 3: Validation of elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents. ISO22442-3: 2007.
9. 国家食品药品监督管理局. 动物源性医疗器械产品注册申报资料指导原则食(药监办械函[2009]519号). 2009.
10. 中华人民共和国医药行业标准动物源性医疗器械第1部分: 风险管理应用. YY/T0771.1-2009. 北京: 中国标准出版社, 2009.
11. 中华人民共和国医药行业标准动物源性医疗器械第2部分: 来源、收集与处置的控制. YY/T0771.2-2009. 北京: 中国标准出版社, 2009.
12. 中华人民共和国医药行业标准动物源性医疗器械第3部分: 病毒和传播性海绵状脑病(TSE)因子去除与灭活的确认. YY/T0771. 3-2009. 北京: 中国标准出版社, 2009.
13. 巩薇, 付瑞, 王吉, 等. 动物源性生物制品病毒灭活/去除工艺的验证. 中国生物制品学杂志, 2007, 20(12): 920-923.
14. 王憬惺. 病毒灭活确证实验和结果评价. 中国输血杂志, 1996, 9(2): 107-109.
15. 蒋丽霞, 顾其胜, 李健, 等. 医用几丁糖病原体灭活/去除工艺的研究. 中国修复重建外科杂志, 2009, 23(2): 222-225.
16. 马平, 周锡鹏, 梅芳, 等. 胶原蛋白海绵生产中的病毒灭活工艺效果观察. 中国消毒学杂志, 2011, 28(3): 286-288.
17. 中华人民共和国卫生部. 消毒技术规范. 北京: 中华人民共和国卫生部, 2002: 24-47.
18. 中华人民共和国农业部. 动物病原微生物分类名录. 北京: 中华人民共和国农业部令第53号, 2005.
19. Sterillization of single-use medical devices incorporating materials of animal rigin—Validation and routine control of sterilization by liquid sterilants. ISO14160: 1998.
20. 医疗保健产品灭菌确认和常规控制要求辐射灭菌. GB18280-2000. 北京: 中国标准出版社, 2000.

Chinese Journal of Reparative and Reconstructive Surgery

TECHNICAL STUDY ON INACTIVATING/REMOVING VIRUS IN COLLAGEN SPONGE

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