Youth is the cleanroom supplier in China, our main products are air filter, purification equipment, cleanroom furniture, cleanroom panel system.  In this post, we will share with you about the features of biopharmaceutical factories:

1. Biopharmaceutical factories not only have high equipment costs, complex production processes, high cleanliness and sterility requirements, but also strict requirements on the quality of production personnel.

2. Potential biological hazards will occur during the production process, mainly infection risks, dead bacteria or dead cells and components or metabolism to the human body and other organisms, sensitization and other biological reactions, product toxicity, Sensitization and other biological reactions, environmental effects.

Cleanroom Supplier: Clean Area

The building structure, equipment, and use of the room (area) that needs to control dust particles and microbial pollution in the environment have the function of preventing the introduction, generation and retention of pollutants in the area.

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Air Lock Room:

An isolated space with two or more doors set between two or more rooms (such as rooms with different cleanliness levels). The purpose of setting up an air lock room is to control the air flow when people or materials enter and exit the room. Air lock room is divided into personnel air lock room and material air lock room.

The basic feature of the clean room of biopharmaceuticals is that dust particles and microorganisms must be used as environmental control objects. The cleanliness of the pharmaceutical production workshop is divided into four levels: partial 100, 1000, 10000 and 30000 under the background of 100 or 10000.

The temperature of the clean room from cleanroom supplier: :

Without special requirements, the relative humidity should be between 18 and 26 degrees and the relative humidity should be between 45% and 65%. Pollution control in the clean workshop of biopharmaceuticals: pollution source control, spreading process control, cross-contamination control. The key technology of clean room medicine mainly lies in the control of dust and microorganisms.

As pollutants, microorganisms are the top priority of environmental control in the clean room. The contaminants accumulated in the equipment and pipelines in the clean area of the pharmaceutical factory can directly contaminate the drugs without affecting the cleanliness detection. The cleanliness level is not suitable for characterizing the physical, chemical, radioactive and vitality of suspended particles.

Familiar with the pharmaceutical production process and process, understand the causes of pollution and the places where pollutants accumulate, can master the methods and evaluation criteria for removing pollutants.

 

The following situations generally exist in the GMP technical transformation of the pharmaceutical plant project:

Due to the misunderstanding of subjective perception, the application of clean technology in the pollution control process is unfavorable. Eventually, some pharmaceutical factories have invested heavily in transformation, but the quality of medicines has not been significantly improved.

The design and construction of the medical clean production plant, the manufacture and installation of equipment and facilities in the plant, the raw and auxiliary materials used in production, the quality of packaging materials, and the unfavorable implementation of the control procedures for human and clean facilities will affect product quality.

The reason that construction affects product quality is that there are problems in the process control link, and there are hidden dangers in the installation and construction process, which have the following specific manifestations:
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;
②The color steel plate enclosure structure is not tight, the sealing measures between the clean room and the technical mezzanine (ceiling) are improper, and the closed door is not airtight;
③Decorative profiles and process pipelines have formed dead corners and dust accumulation in the clean room;
④Individual locations were not constructed in accordance with the design requirements and could not meet relevant requirements and regulations;
⑤The quality of the sealant used is not good enough, easy to fall off, and deteriorate;
⑥ The return and exhaust air color steel plates are connected to each other, and the dust enters the return air duct from exhaust air;
⑦ The inner wall weld is not formed when welding stainless steel sanitary pipes such as purified water and injection water;
⑧ The air duct check valve fails to operate, and the air backflow causes pollution;
⑨The installation quality of the drainage system is not good enough, and the pipe racks and accessories are easy to collect dust;
⑩ The clean room pressure difference setting is unqualified and fails to meet the production process requirements.

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