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目的为规范无菌包装封口工艺确认工作,北京市药品监督管理局医疗器械技术审评中心根据相关的标准要求、结合当前医疗器械质量管理体系考核工作的实际情况,开展了对无菌医疗器械的包装封口工艺课题研究,制定了无菌包装封口工艺确认的基本要求。方法给出了无菌包装封口工艺确认的程序、应达到的生产能力要求、应执行的标准、应形成的文件以及选择无菌包装材料应考虑的因素,结合这些因素进行阐述关于无菌包装封口工艺确认的研究。结果与结论将通过关于无菌包装封口工艺确认研究的结果,形成对于无菌包装封口工艺确认的基本要求,并予以公示。
Objective To standardize the aseptic packaging and sealing process validation work, Beijing Municipal Medical Device Medical Technology Review Center in accordance with the relevant standards, combined with the current medical device quality management system assessment of the actual situation, carried out on the sterile medical devices Packaging sealing technology research, developed aseptic packaging sealing process to confirm the basic requirements. Methods The procedures for the confirmation of the aseptic packaging and sealing process, the production capacity requirements to be met, the standards to be implemented, the documents to be formed and the factors that should be considered when choosing aseptic packaging materials are given. Process validation studies. RESULTS AND CONCLUSIONS The results of the study were confirmed through the aseptic package sealing process, which established the basic requirements for validation of the aseptic package sealing process and made public.