1, Biopharmaceutical plants are not only expensive equipment, complex production process, high requirements for cleanliness and sterility. Have strict requirement to the quality of production personnel.
2, Potential biological hazards can occur during production. The main risk is infection, Dead bacterial or dead cells metabolism have toxic and sensitization for human and other biological reactions.
Rooms(areas) where dust and microbial contamination in the environment needs to be controlled, It's architecture, equipment and its tools have function of preventing introduction, generation and retention of pollutants into the clean room.
Set between tywo or more rooms,(e.g between rooms of different cleanliness levels) a space with two or more doors. The purpose of setting air lock room is when personnel or materials enter and leave controlling the air flow. The air lock room has a personnel aor lock room and material gas lock.
The basic features of the purification chamber of biophrmaceutical: Is must take the dust particle and the microorganism as the environment control object. There are four levels of cleanliness in drug production workshops: 100 class , 1,000 class, 10,000 class, and 30,000 class.
The temperature of the clean room: when no special requirements, at 18~26 degrees, relative humidity is controlled at 45 %~65% .
Pollution control in biological pharmaceutical clean plant: pollution source control, dissemination process control, cross contamination control.
The key technology of purification room is to control dust and microorganism. Microorganism is the most important part of environmental control .Contamination accumulated in equipment/ pipes so that drugs can be contaminated directly without affecting cleanliness detection. The cleanliness grade does not represent to paricals physical, chemical, radioactive and property of life.
The folllowing situations generally exist in the technological transformation of pharmaceutical plant.
1, Clean air conditon system air ducts inside not clean, conection is not tight and the air leakage rate is too high;
2, Color steel plate enclosure structure is not tight, improper sealing of clean room and techinal interlayer(ceiling), air-tight door not closed;
3, The decoration profile and process pipeline form a dead corner there are dust accumulation place;
4, Individual locations are not constructed accorcing to design requirements
5, The quality of the sealant used in easy to exfoliate and deteriotate;
6, The reture air pipe is connected with the exhaust plate;
7, The inner weld of stainless steel sanitary pipe is not formed;
8, The air duct check valve is out of action and the air is polluted by backfilling;
9, The installation quality of drainage system is poor, pipe rack and other accessories are easy to collect dust;
10， The pressure difference setting of clean room is not up to standard.