With the development of the pharmaceutical industry, the development of clean room technology has been driven, and higher requirements have been placed on the design of clean rooms. The design of biopharmaceutical clean room is a comprehensive technology. Only by fully understanding the design characteristics of biopharmaceutical purification projects and realizing a reasonable design can the production efficiency of the biopharmaceutical industry be improved.

Biopharmaceutical Factory Features:

1. The biopharmaceutical factory not only has high equipment cost, complex production process, high requirements on cleanliness and sterility, but also strict requirements on the quality of production personnel.

2. Potential biological hazards will occur in the production process, mainly including (dead bacteria or dead cells and their components or the risk of infection, toxicity, sensitization and other biological reactions to the metabolism of the human body and other organisms, product toxicity, sensitization, etc.) and other biological responses, environmental responses.

Cleaning area:

The building structure, equipment and use of rooms (areas) that need to control dust and microbial contamination in the environment have the function of preventing the introduction, generation and retention of pollutants in the area.

Air lock:

An isolated space with two or more doors between two or more rooms, such as between rooms of different cleanliness levels. The purpose of setting up an airlock is to control the airflow when people or materials enter and exit. There are personnel airlocks and material airlocks between the airlocks. The basic feature of biopharmaceutical clean plants is that dust and microorganisms must be the objects of environmental control.

The key technology in the clean room of a pharmaceutical factory is the control of dust and microorganisms. As a pollutant, microorganisms are an important part of the environmental control of the clean room of the pharmaceutical factory. The pollutants accumulated in the equipment and pipelines in the clean area of the pharmaceutical factory can directly contaminate the medicines, but do not affect the cleanliness test. So we say: GMP requires air purification technology, and air purification technology does not represent GMP.

The reason for the impact of construction on product quality is that there are process control problems and hidden dangers in the process of installation and construction. The specific manifestations are as follows:

① The inner wall of the air duct of the purification air conditioning system is not clean, the connection is not tight, and the air leakage rate is too large;

② The color steel plate enclosure structure is not tight, the sealing measures of the clean room and the technical interlayer (ceiling keel) are improper, and the door is not closed;

③Decorative profiles and process pipes form dead corners and ash accumulation in the clean room;

④ Individual posts are not constructed according to the design requirements and cannot meet the relevant requirements;

⑤ The quality of the sealant used is not good enough, and it is easy to fall off and deteriorate;

⑥Connect the return air and exhaust color steel plates, and the dust enters the return air passage from the exhaust air;

⑦ Pure water, injection water and other stainless steel sanitary pipes do not form inner wall welds during welding;

⑧ The air duct check valve does not work, and the air is poured back causing pollution;

⑨ The installation quality of the drainage system is not closed, and the pipe rack and accessories are easy to accumulate dust;

⑩ The pressure difference setting of the clean room is unqualified and cannot meet the requirements of the production process.

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 Suzhou Pharma Machinery Co.,Ltd.

2022/02/14

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