As you know, clean rooms are very important to biopharmaceutical plants. Since the production environment has critical relations with people’s health, the pharmaceutical clean room classification is high. But do you know their characteristics?
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Below are the characteristics:
High cost and requirement. The biopharmaceutical factory’s equipment costs are high, and the production processes are very complex. Therefore, it has high requirements for cleanliness and sterility. And it has strict requirements on the production personnel.
The potential biological hazards will occur during the production process. They are infection risk, dead bacteria or dead cells and components or metabolism to the human body and other organisms, sensitization and other biological reactions, product toxicity and other biological reactions, environmental effects.
For the above two reasons, there are some requirements for a different part of the cleanroom system. Let’s check the details:
To control dust particles and microbial pollution in the environment, the building structure, equipment, and use of the room prevent the pollutants in the area.
The building structure, equipment, and use of the room (area) need to prevent the introduction, generation, and retention of pollutants in the area.
The airlock room is an isolated space with two or more doors arranged between two or more rooms. The purpose of setting up the airlock room is to control the airflow when people or materials enter and exit the room. And the airlock room has two divisions: a personnel airlock room and a material airlock room.
And the basic feature of the pharmaceutical clean rooms is that dust particles and microorganisms must be the environmental control objects.
There are four levels for the cleanliness of the pharmaceutical production workshop, and they are partial 100, 1000, 10000, and 30000 under the background of 100 or 10000. And the temperature of the clean room should be at 18 to 26 degrees. Meanwhile, the relative humidity is between 45% to 65%.
The key technology of clean room medicine mainly lies in the control of dust and microorganisms. As pollutants, microorganisms are the top priority of the environment control to the clean room. The contaminants accumulated in the equipment and pipelines in the sterile area of the pharmaceutical factory can directly contaminate the drugs without affecting the cleanliness detection.
Therefore, we can say: GMP requires air purification technology, and air purification technology does not represent GMP! The cleanliness level is not suitable for characterizing the physical, chemical, radioactive, and vitality particles.