The key technology of the clean room of the pharmaceutical factory is mainly to control dust and microorganisms. As a pollutant, microorganisms are the top priority in the environmental control of clean rooms in medical plants. The equipment and pipes in the clean area of ​​the pharmaceutical factory can directly pollute the drugs without affecting the cleanliness test. Therefore, we say: GMP requires air purification technology , and air purification technology does not represent GMP ! Cleanliness levels are not intended to characterize the physical, chemical, radiological, and vital properties of suspended particles. Pharmaceutical production process and are not familiar with the process, do not understand the reasons for pollution and pollutants accumulation place, do not have to clear pollutants methods and evaluation criteria that meet the requirements of the cleanliness of the clean room will be able to produce high-quality drugs are GMP recognized A big mistake on the top.
After I have investigated the environmental situation of the clean areas of many pharmaceutical factories in the northeast region (the production has been put into production), the following two situations are common in the GMP technology transformation medical plant project:
　　
(1) Due to the misunderstanding of subjective cognition, the application of clean technology in the process of pollution control is unfavorable. After the emergence of some pharmaceutical companies to invest heavily, the quality of the drug has not improved significantly.
　　
The design and construction of pharmaceutical clean production plants, the manufacture and installation of equipment and facilities in the plant, the quality of raw and auxiliary materials used for production, the quality of packaging materials, and the unfavorable implementation of the net facility control procedures will affect the quality of products.
　　
I have analyzed and analyzed that the reason for the impact of product quality on the construction is that there are problems in the process control process, and there are hidden dangers in the process of installation and construction, which have the following specific performances:
　　
1 Clean air conditioning system The inner wall of the air duct is not clean, the connection is not tight, and the air leakage rate is too large;
　　
2 The color steel plate enclosing structure is not tight, the sealing measures of the clean room and the technical interlayer (ceiling) are improper, and the closed door is not closed;
　　
3 Decorative profiles and process pipelines form dead corners and dust in the clean room;
　　
4 The individual locations are not constructed in accordance with the design requirements and cannot meet the relevant requirements;
　　
The quality of the sealant used in 5 is not good, easy to fall off, and deteriorated;
　　
6 times, the exhaust color steel plate is connected, the dust from the exhaust air to the return air passage;
　　
7 Process stainless steel sanitary pipes such as purified water and injection water are not formed when the inner wall weld is welded;
　　
8 air passage check valve malfunctions, air pollution causes pollution;
　　
9 drainage system installation quality is not closed, pipe racks, accessories are easy to accumulate dust;
　　
10 The pressure difference of the clean room is unqualified and fails to meet the production process requirements.
　　
Therefore, for each professional installation engineering company, whether the clean room engineering construction is high or low, it must be the engineering part of the pharmaceutical factory to control the process before the pollution source enters.
(2) Most pharmaceutical companies' clean room HVAC systems have poor energy-saving effects, resulting in unnecessary expenditures and increasing the production costs of medicines.
　　
For example, some pharmaceutical purification workshops are barely qualified when they are in air or static test cleanliness. Under dynamic test (production) conditions, the cleanliness is not ideal; therefore, the air conditioning unit has to be set to Max operating conditions (so The number of times of gas reaches a large value relative to zui), so that the indoor cleanliness is required. The increase in the number of air changes will inevitably lead to increased energy consumption, unnecessary expenditures, and increased production costs of drugs.
　　
Some pharmaceutical factory investors have reduced the requirements of design requirements to save initial investment, and purchase relatively low-cost equipment such as chillers, pumps, fans and medicine machines. These seemingly cheap equipments are inefficient and quietly consume energy. Investors are not worth the candle.
　　
Some process equipments have large fluctuations in exhaust air volume during operation, and no variable air volume exhaust fans are used to achieve energy saving; more exhaust air heat is not recovered.
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