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1、Air and contamination control 空气和污染控制,Air and contamination control 空气和污染控制,Without air we cannot breathe, so as long as we require personnel to operate our processes we need an air supply. 没有空气我们无法呼吸，所以只要我们需要人员操作我们的工艺，我们就需要空气供应。 Even in clean rural areas air is contaminated with about 108 particles
2、 of 0.5m and greater per m3, many of these will be microorganisms depending on the nature of the area and the season of the year so air is a contamination problem 即使在干净的农村地区，空气也被大约108颗每平方米0.5微米甚至更大的颗粒污染，其中许多是微生物，这取决于该地区的性质和一年中的季节 - 因此空气是一个污染问题 However in the pharmaceutical industry air flow is the a
3、nswer to many contamination problems然而，在制药工业中，空气流动是许多污染问题的答案 So we are going to discuss this dual relationship of the pharmaceutical industry with air因此，我们将讨论制药业与空气的这种双重关系,Air as a contamination source 空气作为污染源,Microorganisms do not grow and increase in numbers in air 微生物不会在空气中生长和增加 Most microorganis
4、ms find it hard to survive in air because the environment is so desiccating and because of the exposure to UV radiation. 大多数微生物发现它难以在空气中存活，因为环境是如此干燥并且因为暴露于紫外线辐射 Survival often depends on being carried on “rafts” of physical matter, such as skin flakes. 生存通常取决于携带物理物质的“筏”，例如皮屑。 Typical airborne microo
5、rganisms are spores of the genus Bacillus and related genera, and Micrococcus or Staphylococcus. 典型的空气传播微生物是芽孢杆菌属和相关属的孢子，以及微球菌或葡萄球菌。,Controlling airborne contamination in cleanrooms控制洁净室中的空气污染,There are four principle applying to control of air-borne microorganisms in clean rooms. 控制洁净室中的空气传播微生物有四个原
6、则。 Filtration 过滤 Dilution 稀释 Directional Air Flow 定向气流 Air Movement 空气运动 I will address each one separately,Filtration,Filtration removes microorganisms:过滤去除微生物： HEPA (high efficiency particulate air) filters remove up to about 99.997% of particles from air HEPA（高效微粒空气）过滤器可从空气中去除高达约99.997的颗粒 HEPA Fi
7、lters are protected from blockage by pre-filters which remove up to about 90% of particles from air HEPA过滤器通过预过滤器防止堵塞，预过滤器可从空气中去除多达约90的颗粒,Therefore if air contains about 3 x 108 particles per m3, and you have one pre-filter and one HEPA Filter: 因此，如果空气中每立方米包含约3 x 108个颗粒，并且您有一个预过滤器和一个HEPA过滤器： Pre-fil
8、ter leaves about 3 x 107 per m3 as a challenge to the HEPA filter 预过滤器每立方米约3 x 107，作为对HEPA过滤器的挑战 The terminal HEPA Filter leaves about 103 per m3. 终端HEPA过滤器每立方米留下约103个。 In EU GMP this is within the limits for Grade A and B “at rest” (Annex 1.4) 在欧盟GMP中，这是A级和B级“静态”的限制（附件1.4）,Filtration过滤,In fact most
9、 pharmaceutical air handling system recirculate up to 80% of the air supplied to clean rooms. 实际上，大多数制药空气处理系统再循环高达80的空气供应给洁净室。 Therefore the initial challenge to the HEPA Filters is probably only about 106 particles per m3. 因此，对HEPA过滤器的最初挑战可能是每立方米仅约106个颗粒。 So we probably get no more than 3 x 102 par
10、ticles per m3 supplied to pharmaceutical clean rooms 因此，我们可能每立方米提供不超过3 x 102颗粒供应给制药洁净室 This is even further within the limits of Grade A and Grade B “at rest” in EU GMP (Annex 1.4)这进一步在欧盟GMP中的A级和B级“静态”范围内（附件1.4）,Filtration过滤,Air must be passed through HEPA filters 空气必须通过HEPA过滤器 These will have a cer
11、tified “efficiency rating” which applies to the medium 这些将具有适用于介质的经认证的“效率等级” BPL uses H14 filters BPL使用H14过滤器 On installation and at interval it is necessary to test the integrity of the whole assembly of filter and ductwork 在安装和间隔时，有必要测试整个过滤器和管道系统组件的完整性,Filtration过滤,Typical HEPA filter installation
12、典型的HEPA过滤器安装,Filtration过滤,Because potential leakage is not confined to the filter media there is a requirement to perform an In Situ Filter INTEGRITY Test 由于潜在泄漏不仅限于过滤介质，因此需要执行原位过滤器完整性测试 This is commonly called the DOP test after Di-octyl phthallate one of the first substances used as an aerosol cha
13、llenge for this test 这通常被称为DOP测试之后的二辛基邻苯二甲酸酯作为该测试的气溶胶挑战的第一种物质之一 The standard is that the tolerable leakage of an aerosol challenge shall be not more than 0.01% - this is NOT the reciprocal of the efficiency 标准是气溶胶挑战的可容忍泄漏不应超过0.01 - 这不是效率的倒数,Dilution稀释,Particles build up in enclosed spaces where ther
14、e is no ventilation that is why in the past there was so much tuberculosis in winter in the slums of northern Europe 颗粒在没有通风的封闭空间中积聚 - 这就是为什么过去在欧洲北部贫民窟冬季有如此多的结核病 Ventilation is the process by which any particles generated in clean rooms (in addition to those which pass the filters) are carried away
15、for any remaining in the room to be diluted with new “clean” air 通风是将洁净室中产生的任何颗粒（除了通过过滤器的颗粒）带走的过程，以便用新的“清洁”空气稀释房间内剩余的任何颗粒。 The minimum ventilation rate expected in pharmaceutical clean rooms is 20 air changes per hour (the modern requirement up to twice as many as this, and up to 75 for a changing r
16、oom) the air in a clean room is replaced at least every 3 minutes. An office might have 2-3 air-changes per hour. 制药洁净室预计的最低通风率为每小时20次换气（现代要求高达此数量的两倍，更换房间高达75次） - 洁净室内的空气至少每隔3分钟更换一次。 办公室每小时可能有2-3次换气。,Dilution稀释,Ventilation is measured as air changes per hour 通气量以每小时换气量来衡量 This is not a “real” measure, it is a calculated measure based on air velocity measurement 这不是“真实”测量，它是基于空气速度测量的计算测量 The air velocity is measured close to its point of entry into the clean-room using an anemometer
