医药净化与电子净化之间的不同之处
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- 发布日期：2017-04-13 16:50:17
医药厂房洁净室关键技术主要在于控制尘埃和微生物，作为污染物质，微生物是医药厂房洁净室环境控制的重中之重。医药厂房洁净区的设备、管道内积聚的污染物质，可以直接污染药品，却毫不影响洁净度检测，所以我们说：GMP需要空气净化技术，而空气净化技术不代表GMP！洁净度等级不适用于表征悬浮粒子的物理性、化学性、放射性和生命性。不熟悉药品生产工艺和过程，不了解造成污染的原因和污染物质积聚的场所，不掌握清除污染物质的方法和评价标准，以为洁净度满足要求的洁净室就能生产出高质量药品是GMP认识上的一大误区。
The key technology of the clean room in the pharmaceutical factory is to control the dust and microorganisms, as the material, the microorganism is the most important in the environmental control of the clean room of the pharmaceutical factory. Pharmaceutical factory clean area of equipment, the accumulation of pollutants in the pipeline, can be directly contaminated drugs, but not affect the cleanliness testing, so we say: GMP need air purification technology, and air purification technology does not mean GMP! Cleanliness class does not apply to the characterization of physical, chemical, radioactive, and life of suspended particles. Not familiar with drug production process and process, do not understand the cause of pollution and the accumulation of pollutants in the place, do not grasp the methods and evaluation criteria for the removal of pollutants, and that the clean room to meet the requirements of the clean room will be able to produce high quality medicine is a big misunderstanding GMP.
GMP技术改造医药厂房工程普遍存在以下两种情况：
There are two kinds of GMP technology in the pharmaceutical factory building:
（一）正由于存在主观认识上的误区，在污染控制过程中的洁净技术应用不利，最终出现了有的药厂投入巨资改造后，药品质量并未明显提高。
(a) is due to the presence of subjective errors, in pollution control in the process of clean technology application, the final emergence of some pharmaceutical companies invested heavily in the transformation, the quality of drugs did not significantly improve.
医药洁净生产厂房的设计、施工、厂房内设备设施的制造、安装，生产用原辅物料、包装材料质量、人净物净设施控制程序执行不利等都会影响产品质量。
The design, construction and installation of equipment and facilities in the clean production plant, the production of raw materials, packaging material quality, and the implementation of the control program of the net material of the person will affect the quality of products.
本人经过分析认为：施工方面影响产品质量的原因是过程控制环节有问题，在安装施工过程中留有隐患，有如下具体表现：
I have analyzed that: the construction of the product quality is the cause of the process control link is a problem, in the installation of the construction process to stay hidden, there are as follows:
①净化空调系统风道内壁不干净、连接不严密、漏风率过大；
The clean air conditioning system in the inner wall of the air channel is not clean, not tight connection, the leakage rate is too large;
②彩钢板围护结构不严密，洁净室与技术夹层（吊顶）的密封措施不当、密闭门不密闭；
II color steel structure is not tight, clean room and Technology (suspended) of the sealing measures, closed door is not closed;
③装饰型材及工艺管线在洁净室形成了死角、积尘；
In the clean room, the decoration materials and the process pipeline form a dead angle and dust accumulation;
④个别位置未按照设计要求施工，无法满足相关要求规定；
The position of the individual is not in accordance with the design requirements of the construction, can not meet the relevant requirements;
⑤所用密封胶质量不过关、易脱落、变质；
The quality of the sealant, easy to fall off, metamorphism;
⑥回、排风彩钢板夹道相通，粉尘从排风到进入回风道；
The back row, the wind color steel lined interlinked, dust from the exhaust air to enter the air return way;
⑦工艺纯化水、注射水等不锈钢卫生管道焊接时内壁焊缝未成型；
The purification process of water injection, water and other sanitary stainless steel pipe welding weld forming wall;
⑧风道止回阀动作失灵，空气倒灌造成污染；
The air check valve action failure, air pollution caused by intrusion;
⑨排水系统安装质量不过关、管架、附件易积尘；
9 drainage system installation quality, pipe rack accessories, easy dust;
⑩洁净室压差整定不合格，未能满足生产工艺要求。
The clean room pressure setting failed, failed to meet the requirements of the production process.
所以，针对每个专业安装工程公司，洁净室工程施工无论洁净度的高还是低，都必须为药厂作好工程部分对污染源进入前的过程控制。
So, in each professional installation engineering company, clean room engineering construction whether cleanliness of high or low, must for pharmaceutical companies to prepare for part of the project before entering the pollution source of process control.
（二）大多数药厂洁净室节能效果差，形成不必要的支出，加大了药品的生产成本。
(two) the majority of pharmaceutical cleanroom energy-saving effect, the formation of unnecessary expenditure, increase the drug production cost.
比如有些药厂净化车间在空态或静态测试洁净度时，勉强合格，在动态测试（生产）条件下，洁净度不理想；所以不得不把空调机组变频调速设置为Max工况（如此换气次数即达到相对最大值），以使室内洁净度达到要求。换气次数的增加势必会导致能耗加大，形成不必要的支出，加大了药品的生产成本。
For example, some pharmaceutical purification workshop in the empty state or static test cleanliness, barely qualified, under the condition of dynamic testing (production), cleanliness is not ideal; they have to put air conditioning unit variable frequency speed setting for max condition (so ventilation frequency reached a relative maximum), in order to make the indoor cleanliness attaining the requirements. The increase in the number of air exchange is bound to lead to increased energy consumption, the formation of unnecessary spending, increase the production costs of drugs.
有的药厂投资人为节约初投资而擅自降低设计要求的条件，购置价格相对低廉的设备如冷水机组、水泵、风机和药机，这些看似便宜的设备效率低，悄悄的把能量白白消耗掉，使投资人得不偿失。
Some pharmaceutical companies invested people save the initial investment arbitrarily reduce design requirements, purchase relatively inexpensive equipment such as chillers, water pump, fan and medicine machine, these seemingly cheap equipment efficiency low, quietly take white energy consume, make investors more harm than good.
有些工艺设备运行时排风量波动大，而没有采用变风量排风机来实现节能；更有较多排风废热未被回收。
Some of the process equipment operation when the exhaust volume fluctuations, without the use of variable air volume exhaust fan to achieve energy-saving; more exhaust waste heat of wind have not been recovered.
