吹灌封技术的法规要求概述

An Overall Regulatory Review of BFS Technology

综述了我国、欧盟和美国等国内外药政机构和相关组织对吹灌封技术在医药和无菌医疗器械行业的相关法规要求和技术指导原则,通过总结、比较和阐述,为国内该项技术的应用和发展提供指导和借鉴,旨在推动相关法规的完善和促进该无菌保证技术在国内的良好应用和发展。

The article summarizes regulatory requirement and technical guideline for BFS （Blow-FillSeal） technology of sterile medicine and medical devices by the medical agencies and other organization in China, Europe and USA. The summary, contrast and analysis gives the guidance and study to the BFS technology in order to promote the regulatory improvement and the better practice and development in China.