制药厂高效送风口PAO验证测试

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 and coming new GMP standard has severe requirements for facilities and equipments. All of above things need to pa ss a 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 is a 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-RP-CC034.1 标准，可接受之泄漏量

是小于上游质量浓度的0.01% 。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0.01% 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 0.01% compared with the aerosol concentration upstream. It means that we must calibrate the aerosol density

and particle size before we start to test. 北京中大杏林医药研究院

1-3、具体方法是：首先在高效过滤器上游段注入10ug/L~20ug/L 浓度的PA O

气溶胶，在保持这个质量浓度不变的前提下，在送风口出风面用

photometer 检测泄漏出来的气溶胶，其质量浓度不能超过上游浓度的

0.01% ，否则就表明这个送风口不合格，必须调整或更换。

Operating process: Inject PAO particles at the upstream of the HEPA filter.

When the concentration is accumulated to 10ug/l~100ug/l and is stable, we

can use photometer to scan the HEPA surface at the distance within 15mm.

1-4、送风口可能存在的泄漏点：包括送风静压箱体、高效过滤器滤芯和密封

垫等三部分。因此，我们要确保通过PA O 测试，必须同时保证以上三部

分不会出现泄漏。

Possible leaking points: housing, HEPA filter and Gasket. If we need to pass the scanning, above three parts mu st not have leaking point.

2、高效过滤器生产厂家是怎样保证生产质量的？How to ensure the filter quality

for those HEPA filter manufacturer?

实际上，每个高效过滤器生产厂家在生产过程中都会出现不合格品，因此对于

高效过滤器而言，在出厂前必须对每台高效进行效率测试，并提供唯一的可追溯生产编号的验证测试报告。目前大家比较接受的高效过滤器测试标准是欧盟EN1822 标准系列，这在ISO14644 里面有详细叙述。

Actually defective products always ha ppens when suppliers are assembling HEPA filters. So each filter needs to be factory tested before delivery and should be labeled with a unique serial number so that they can tr ace back to the manufacturing process once defect is found. The test report should also contains various kinds of testing information base on EN1822.

3、生产厂家提供的数据可信吗？北京中大杏林医药研究院

如果一个过滤器生产厂家提供的是人工书写的效率标识与测试报告，那么可以