华创证券：医疗器械行业报告

tianyustar

目 录
1 新版GMP正在改变制药工业 ................................................................................................... 4
1.1 新版GMP主要变化 ......................................................................................................... 4
1.2 新版GMP的重点是洁净度 ............................................................................................. 4
1.2.1 洁净度级别升级 ......................................................................................................... 4
1.2.2 人是最大的污染源 ..................................................................................................... 5
1.2.3 洁净度要求推动设备更新 ......................................................................................... 6
1.3 新版GMP更新带来行业机遇与挑战 ............................................................................. 7
2 新版GMP是药机行业的机遇和挑战 ....................................................................................... 7
2.1 灭菌设备 ............................................................................................................................ 8
2.1.1 灭菌方法 ..................................................................................................................... 8
2.1.2 灭菌设备厂家 ............................................................................................................. 9
2.1.3 新版GMP带来灭菌设备市场机遇 ........................................................................ 102.2 干燥设备 .......................................................................................................................... 112.2.1 干燥设备新机遇 ....................................................................................................... 112.2.2 干燥设备现状 ........................................................................................................... 112.2.3 冷冻干燥设备成为制药行业的宠儿 ....................................................................... 122.2.4 未来三年冻干机市场容量有望超过70亿元 ......................................................... 132.3 大输液洗灌封生产线 ...................................................................................................... 142.3.1 大输液包材向非PVC包装发展 ............................................................................. 142.3.2 大输液生产线将受益于新版GMP和行业趋势 .................................................... 152.3.3 未来预测 ................................................................................................................... 162.4 空气净化设备 .................................................................................................................. 16