Views:0 Author:Site Editor Publish Time: 2021-05-12 Origin:Site
Biopharmaceutical venues are not only high equipment costs, complex production process, clean level and sterile requirements, and strict requirements for the quality of producers. There will be potential biological hazards in the production process, mainly (infected hazards, dead strains or dead cells and components or metabolism to human and other biological shoulders, sensitivity, etc. Sensitivity and other biological reactions, environmental effects.)
Regions which require control of dust and microbial contamination in the environment, its building structure, equipment and its use have functions that prevent the introduction, production and retention of pollutants in the region.
The isolation space provided between two or several rooms (such as the rooms of different cleanliness levels) has two or more doors. The purpose of setting the air lock is to control the airflow when the person or material is inserted. There are people in the air lock between the air lock and the material atmosphere.
Basic Characteristics of Biopharmaceutical Clean Factory: It is necessary to control objects with dust particles and microorganisms.
Pharmaceutical production workshop cleanliness is divided into four levels: A / B / C / D.
The temperature of the clean room: under no special requirements, at 18 to 26 degrees, the relative humidity is controlled at 45% to 65%.
Biopharmaceutical Clean Waters Pollution Control: Pollution Source Control, Broadcast Process Control, Cross - pollution Control.
The key technology of the purification room of pharmaceutical factory is mainly to control dust and microorganisms. As pollutants, microorganisms are the top priority of the environmental control of pharmaceutical plant purification room. The equipment of the medical factory clean area, the contaminated substance accumulated in the pipeline can directly pollute the drug, but it does not affect cleanliness detection, so we said: GMP requires air purification technology, and air purification technology does not represent GMP! The cleanliness rating is not suitable for physical, chemical, radioactivity, and life of suspension particles. Do not familiarize with drug production process and processes, do not understand the causes of pollution and pollution substance accumulation, do not master methods and evaluation criteria for removing pollutants.
GMP technology retrofit pharmaceutical factory projects have generally presented the following:
Due to the misunderstanding of subjective understanding, clean technology in the process of pollution control is unfavorable, and after the introduction of drug factories have been put into huge investment, the quality of drugs did not increase significantly.
The design, construction, installation, installation of equipment facilities in the factory, and the quality of the equipment, the quality of packaging materials, and the quality of the netware facilities control procedures will affect product quality.
The reason for the quality of the product is the problem of the quality of the process control, there is a problem in the installation process, and there is a specific performance as follows:
1 Purify the inner wall of the air conditioner system is not clean, the connection is not strict, the leakage is too large;
2 The color steel plate enclosure is not tight, the sealing measures of clean room and technology sandwich (ceiling) are not properly closed; the closed door is not sealed;
3 Decorative profiles and process pipeline form dead angles in clean rooms;
4 The individual positions did not work according to the design requirements, and the relevant requirements were not met;
5 The quality of the sealed rubber used is not too much, easy to fall, and deteriorate;
6 back, the ventilation steel plate is connected, the dust is from the exhaust to the return airway;
7 Process purified water, injection water and other stainless steel hygiene pipe welds during welding of inner wall weld;
8 wind turbine check valve movement failure, air inverting causes pollution;
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The cleansing room pressure difference is unqualified, and it is not possible to meet the production process requirements.