制药厂高效送风口PAO验证测试.doc

制药厂高效送风口 PAO 验证测试目前,无论是 FDA 、 cGMP 还是国内即将颁布的新版 GMP 标准都对厂房、辅助设施、设备等提出了必须进行设计确认( DQ ) 、安装确认( IQ ) 、运行确认( OQ ) 和性能确认( PQ )的 4Q 文件管理措施,高效送风口作为只要厂控制洁净度的一个重要设备,也必须进行相应的验证测试与确认。目前国际上比较通行的验证方法是对高效送风口进行 PA O 泄漏验证测试,并且这种方法得到了生物制药行业相关各方共同认可,我们就对这种方法的相关问题简介如下。 FDA, cGMP ing new GMP standard has severe requirements for facilities and equipments. All of above things need to pa ssa serial of proce ss called DQ,IQ,OQ&PQ. As an important factor of field cleanness, HEPA box also needs to pass corresponding validation and qualification. Currently PAO leakag e test isa popular way to detect filter leakage and is accepted by pharmaceutical industry. 1、 PA O 验证什么?怎样验证? What is PAO validation? How to operate? 1-1 、 PA O 验证什么? [ 北京中大杏林医药研究院] 当工程公司从不同的生产厂家采购回来高效送风口和高效过滤器时, 经过运输和安装后, 这个保证洁净区域内洁净度的最重要设备是否存在灰尘与细菌的泄漏问题呢?这个就是需要 PA O 验证要证明的问题。 When subcontractors get HEPA boxes from suppliers and install them on the ceiling, we believe that we need to do some tests to make sure that the housings and HEPA filters are not leaking after a long distance delivery and has no problems on integrity. That ’s why we need to use PAO method to take this test. 1-2 、 PA O 验证的标准与依据:美国 IEST- 标准,可接受之泄漏量是小于上游质量浓度的 % 。即验证的时候必须确认高效过滤器上游段即送风静压箱内有一定浓度的、粒径大小相对稳定的灰尘即气溶胶,在这个浓度下只能允许小于 % 的灰尘泄漏到洁净区域。 The criteria for PAO testing: According to IEST standard, the acceptable number downstream should be less than % compare