新旧版GMP对保健食品洁净室的要求.docxVIP

新旧版 GMP 对保健食品洁净室的要求 保健食品洁净室(区)空气洁净度级别表 (-)各级别空气悬浮粒子的标准规定： 悬浮粒子最大允许数/立方米 (3)洁净度级别静态动态 (2)?0. 5 um ?5. 0 um ?0. 5 um ?5. 0 um (1) A 级 3520 20 3520 20 B 级 3520 29 352000 2900 C 级 352000 2900 3520000 29000 D 级 3520000 29000 不作规定 不作规定 注： (1) 为确认 A 级洁净区的级别，每个采样点的采样量不得少于1 立方米。 A 级洁 净区 空气悬浮粒子的级别为 ISO 4.8,以?5.0n m 的悬浮粒子为限度标准。 B 级洁 净区(静态) 的空气悬浮粒子的级别为 ISO 5,同时包括表中两种粒径的悬浮粒子。 对于 C 级洁净区(静 态和动态)而言，空气悬浮粒子的级别分别为 ISO 7 和 ISO 8o 对于 D 级洁净区(静态)空 气悬浮粒子的级别为 ISO 8o 测试方法可参照 IS014644- lo (2) 在确认级别时，应当使用采样管较短的便携式尘埃粒子计数器，避 免?5.0u m 悬浮粒子在远程采样系统的长采样管中沉降。在单向流系统中，应当釆 用等 动力学的取样头。 (3) 动态测试可在常规操作、培养基模拟灌装过程中进行，证明达到动态的洁 净度 级别，但培养基模拟灌装试验要求在“最差状况”下进行动态测试。 (1) (二)洁净区微生物监测的动态标准 rAt present, we have formed a rAt present, we have formed a three-three Park, according to ....... The instructions of development needs in the next decade, based on extended the 6 square kilometers ? Of the Park, roads, the original, and then power supply, communications, water supply and drainage and sewage pipe network and other to further improve the infrastructure, to achieve full coverage of infrastructure and interconnection with the facilities and raise capacity ? Each park to determine 1 leading industries, in particular stone Materials, cans, gloves, through guided, force and other measures to promote the ， zroad company Park, industrial agglomeration. Currently, to focus on building better .............................. Industrial Park, ...... Wood Park as the starting area of the industrial park, planners need to take out plan, start construction as soon as possible, undertake in a timely manner Transfer of the wood industry. This opportunity slip by, so the timing must be tight ? Second is to optimize government service ? Low efficiency of government services, departments do not coordinate the views of businesses large, poor business environment, it is ................... Short Board, decide to change ? We will continue to deepen reform of the administrative examination and approval system, g