Sterility and Endotoxin of Thai Silk Fibroin Solution in a Production Conformed to ISO13485 Standard
文献类型： 会议论文
第一作者： Aksarapak Rattana
作者： Aksarapak Rattana 1 ; Rungnapha Yamdech 1 ; Siriporn Damrongsakkul 2 ; Juthamas Rattanavaraporn 3 ; Peerapat Thongnuek 4 ; Sorada Kanokpanont 1 ; Antonella Mota 5 ; Phatcharaphon Nopprang 6 ; Siripakorn Sangkitporn 6 ; Acharaporn Dambua 6 ; Patcharaporn Boonchu 6 ; Supaporn Suparak 6 ; Panadda Dhepakson 6 ; Jutarat Jamkratoke 7 ;
作者机构： 1.Center of Excellence in Biomaterial Engineering in Medical and Health
2.Center of Excellence in Biomaterial Engineering in Medical and Health|Department of Chemical Engineering, Chulalongkorn University, Bangkok, Thailand
3.Center of Excellence in Biomaterial Engineering in Medical and Health|Biomedical Engineering Program Faculty of Engineering, Chulalongkorn University, Bangkok, Thailand
4.Biomedical Engineering Program Faculty of Engineering, Chulalongkorn University, Bangkok, Thailand
5.BIOtech Research Center Department of Industrial Engineering, University of Trento, Mattarello, TN, Italy
6.Department of Medical Sciences, Advanced Therapy Medicinal Product Center, Ministry of Public Health, Nontaburi, Thailand
7.The Queen Sirikit Sericulture Center Nakhon Ratchasima, Nakorn Ratchasima, Thailand
关键词： Proteins;Medical devices;Protocols;Production;Optical fiber devices;Public healthcare;Optical fiber testing
会议名称： Biomedical Engineering International Conference
主办单位：
页码： 1-3
摘要： This is the first report of sterile Thai silk fibroin (SF) solution (2-4% (w/v) in water) production at semi-commercial scale under the medical device management system conforming to standard ISO13485:2016. Thai silk cocoons (Bombyx mori, local strain, named Nangnoi Srisaket 1) was maintained, cultured and produced in controlled conditions at The Queen Sirikit Sericulture Center Nakhon Ratchasima, Thailand. The GMP (Medical Device) conformed protocol was optimized. The degummed silk fibers were dissolved in concentrated ionic liquid and purified in the clean room facility of the Department of Medical Sciences, Ministry of Public Health, Thailand. With minimal sterilization of the end product (4%w/w SF Solution), sterility and endotoxin test of the product indicated that the purified proteins were negative for bacteria, mycobacteria, yeast and fungi. The endotoxin levels of all inputs, intermediates and the product was <0.1 EU/ml conforming to the USP standard (for water for injection at the endotoxin level limits <0.25 EU/ml). This indicated that the Thai SF solution can be used for medical and health applications.
分类号： r318-53
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