杨春文 北京思坦瑞制药科技咨询服务有限公司总经理,中国医药设备工程协会专家组成员。大学学历,所学专业:机电、药学、法律。在合资、外资制药企业工作20余年。曾担任药厂工程建设负责人、生产制造部门负责人、药厂高级技术顾问等职位。在无菌药品制造,尤其BFS技术(吹灌封技术)方面,有着丰富的经验,涉及到不同剂型。
目前已为多家药企进行过BFS技术方面的咨询服务。具备的能力:准确评价BFS装备的性能,及其与产品工艺的适应性;指导工艺设计与工艺验证;加速药品与包材的注册、 GMP的认证通过;并能够使得生产线的稳定、高效地运行。
Yang Chunwen General Manager of Beijing Sitanrui Pharmaceutical Technology Consulting Services Co., Ltd., member of expert group of China Pharmaceutical Association of Plant Engineering. University degree, major in electromechanical, pharmacy and laws. He has worked in joint venture, foreign-funded pharmaceutical enterprises for more than 20 years. He once served as engineering construction director of pharmaceutical factory, director of production manufacturing department, senior technical consultant of pharmaceutical factory etc. He has rich experience in manufacturing of aseptic especially BFS technology (blow-fill-seal), involving different preparations. He has provided consulting services concerning BFS technology to many pharmaceutical enterprises. He is capable of accurately evaluating the performance of BFS equipments, their adaptability to product processes, and guiding process design and process validation, and accelerating the registration of drugs and packaging materials, GMP certification, and enabling stable and efficient operation of production line.
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