醫(yī)藥凈化與電子凈化之間的不同之處
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- 發(fā)布日期：2017-04-13 16:50:17
醫(yī)藥廠房潔凈室關鍵技術主要在于控制塵埃和微生物，作為污染物質，微生物是醫(yī)藥廠房潔凈室環(huán)境控制的重中之重。醫(yī)藥廠房潔凈區(qū)的設備、管道內積聚的污染物質，可以直接污染藥品，卻毫不影響潔凈度檢測，所以我們說：GMP需要空氣凈化技術，而空氣凈化技術不代表GMP！潔凈度等級不適用于表征懸浮粒子的物理性、化學性、放射性和生命性。不熟悉藥品生產工藝和過程，不了解造成污染的原因和污染物質積聚的場所，不掌握清除污染物質的方法和評價標準，以為潔凈度滿足要求的潔凈室就能生產出高質量藥品是GMP認識上的一大誤區(qū)。
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技術改造醫(yī)藥廠房工程普遍存在以下兩種情況：
There are two kinds of GMP technology in the pharmaceutical factory building:
（一）正由于存在主觀認識上的誤區(qū)，在污染控制過程中的潔凈技術應用不利，最終出現(xiàn)了有的藥廠投入巨資改造后，藥品質量并未明顯提高。
(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.
醫(yī)藥潔凈生產廠房的設計、施工、廠房內設備設施的制造、安裝，生產用原輔物料、包裝材料質量、人凈物凈設施控制程序執(zhí)行不利等都會影響產品質量。
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.
本人經過分析認為：施工方面影響產品質量的原因是過程控制環(huán)節(jié)有問題，在安裝施工過程中留有隱患，有如下具體表現(xiàn)：
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凈化空調系統(tǒng)風道內壁不干凈、連接不嚴密、漏風率過大；
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彩鋼板圍護結構不嚴密，潔凈室與技術夾層（吊頂）的密封措施不當、密閉門不密閉；
II color steel structure is not tight, clean room and Technology (suspended) of the sealing measures, closed door is not closed;
③裝飾型材及工藝管線在潔凈室形成了死角、積塵；
In the clean room, the decoration materials and the process pipeline form a dead angle and dust accumulation;
④個別位置未按照設計要求施工，無法滿足相關要求規(guī)定；
The position of the individual is not in accordance with the design requirements of the construction, can not meet the relevant requirements;
⑤所用密封膠質量不過關、易脫落、變質；
The quality of the sealant, easy to fall off, metamorphism;
⑥回、排風彩鋼板夾道相通，粉塵從排風到進入回風道；
The back row, the wind color steel lined interlinked, dust from the exhaust air to enter the air return way;
⑦工藝純化水、注射水等不銹鋼衛(wèi)生管道焊接時內壁焊縫未成型；
The purification process of water injection, water and other sanitary stainless steel pipe welding weld forming wall;
⑧風道止回閥動作失靈，空氣倒灌造成污染；
The air check valve action failure, air pollution caused by intrusion;
⑨排水系統(tǒng)安裝質量不過關、管架、附件易積塵；
9 drainage system installation quality, pipe rack accessories, easy dust;
⑩潔凈室壓差整定不合格，未能滿足生產工藝要求。
The clean room pressure setting failed, failed to meet the requirements of the production process.
所以，針對每個專業(yè)安裝工程公司，潔凈室工程施工無論潔凈度的高還是低，都必須為藥廠作好工程部分對污染源進入前的過程控制。
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）大多數(shù)藥廠潔凈室節(jié)能效果差，形成不必要的支出，加大了藥品的生產成本。
(two) the majority of pharmaceutical cleanroom energy-saving effect, the formation of unnecessary expenditure, increase the drug production cost.
比如有些藥廠凈化車間在空態(tài)或靜態(tài)測試潔凈度時，勉強合格，在動態(tài)測試（生產）條件下，潔凈度不理想；所以不得不把空調機組變頻調速設置為Max工況（如此換氣次數(shù)即達到相對最大值），以使室內潔凈度達到要求。換氣次數(shù)的增加勢必會導致能耗加大，形成不必要的支出，加大了藥品的生產成本。
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.
有的藥廠投資人為節(jié)約初投資而擅自降低設計要求的條件，購置價格相對低廉的設備如冷水機組、水泵、風機和藥機，這些看似便宜的設備效率低，悄悄的把能量白白消耗掉，使投資人得不償失。
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.
有些工藝設備運行時排風量波動大，而沒有采用變風量排風機來實現(xiàn)節(jié)能；更有較多排風廢熱未被回收。
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.
