Different characteristics of clean workshop in pharmaceutical industry

Characteristics of biopharmaceutical factory: 1 Biopharmaceutical factory not only has high equipment cost, complex production process, high requirements for cleanliness level and sterility, but also has strict requirements for the quality of production personnel 2 There will be potential biological hazards in the production process, mainly including (risk of infection, toxicity, sensitization and other biological reactions of dead bacteria or dead cells and components or metabolism to human body and other organisms, toxicity, sensitization and other biological reactions of products, environmental effects) Clean area: a room (area) that needs to control dust and microbial pollution in the environment Its building structure, equipment and use have the function of preventing the introduction, generation and retention of pollutants in the area Airlock 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 air lock room is to control air flow when people or materials enter and leave Air lock room is divided into personnel air lock room and material air lock room The basic characteristics of the purification room of biopharmaceuticals: it is necessary to take dust particles and microorganisms as the environmental control objects There are four levels of cleanliness in drug production workshop: local level 100, level 1000, level 10000 and level 30000 under the background of level 100 or level 10000 Clean room temperature: in the absence of special requirements, in 18-26 degrees, relative humidity control in 45% - 65% Pollution control of biopharmaceutical clean workshop: pollution source control, spreading process control, cross pollution control The key technology of medicine in the purification room is mainly to control dust and microorganism As a pollutant, microorganism is the top priority of environmental control in the purification room The accumulated pollutants in the equipment and pipes in the clean area of the pharmaceutical plant can directly pollute the drugs, but will not affect the cleanliness test Therefore, we say: GMP needs air purification technology, while air purification technology does not represent GMP! Cleanliness level is not applicable to characterization of physical, chemical, radioactive and life of suspended particles They are not familiar with the production process and process of drugs, do not know the causes of pollution and the places where pollutants accumulate, and do not master the methods and evaluation standards for removing pollutants There are the following situations in the pharmaceutical plant engineering of GMP technical transformation: due to the subjective misunderstanding, the application of clean technology in the pollution control process is not good, and finally some pharmaceutical plants invest a lot of money in the transformation, and the quality of drugs has not been significantly improved The design and construction of pharmaceutical clean production plant, the manufacturing and installation of equipment and facilities in the plant, the quality of raw and auxiliary materials for production, packaging materials, and the adverse implementation of control procedures for human, net, material and net facilities will affect the product quality The reason for the impact of construction on product quality is that there are problems in the process control link, and there are hidden dangers in the installation and construction process, 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 high; ② The color steel plate enclosure structure is not tight, the sealing measures between the clean room and the technical interlayer (ceiling) are improper, and the closed door is not closed; ③ the decorative profile and the process pipeline form a dead angle and dust accumulation in the clean room; ④ the construction of individual positions is not in accordance with the design requirements, which cannot meet the relevant requirements; ⑤ the quality of the sealant used is not qualified, easy to fall off and deteriorate; ⑥ The air return and exhaust color steel plate channels are connected, and the dust flows from the air exhaust to the air return channel; ⑦ the inner wall weld of stainless steel sanitary pipes such as process purified water and injection water is not formed during welding; ⑧ the check valve of air channel fails to operate, causing pollution due to air backflow; ⑨ the installation quality of drainage system is not qualified, and the pipe rack and accessories are easy to accumulate dust; ⑩ The setting of the pressure difference in the clean room is unqualified and fails to meet the production process requirements GMP requirements for environmental control of the purification project of the drug packaging workshop: 1 Provide the air purification level required for production, regularly test and record the number of air dust particles and living microorganisms in the purification project of the packaging workshop, and keep the static pressure difference between different packaging workshops within the specified value; 2 The temperature and relative humidity of the purification project in the packaging workshop shall be in accordance with the production process requirements; 3 The production areas of penicillin, high sensitivity and anti-tumor drugs shall be equipped with independent air conditioning system, and the exhaust gas shall be purified; 4 The rooms producing dust shall be equipped with effective dust catching devices to prevent cross contamination of dust; 5 For storage and other auxiliary production rooms, the ventilation facilities, temperature and humidity shall be suitable for the requirements of drug production and packaging 2、 Look for the purification project of drug packaging workshop > cleanliness zoning and air change times: the cleanliness of the air in the clean room should be strictly controlled, as well as the ambient temperature, humidity, fresh air volume, pressure difference and other parameters 1 The purification level and air change frequency of the pharmaceutical production and packaging workshop the air cleanliness of the purification project of the pharmaceutical production and packaging workshop is divided into four levels: 100 level, 10000 level, 100000 level and 300000 level To determine the number of air changes in the clean room, it is necessary to compare the air volume of each item, and take the Zui value In practice, the air change rate of 100 stage is 300-400 times / h, that of 10000 stage is 25-35 times / h, and that of 100000 stage is 15-20 times / h 2 The cleanliness of the purification project of the pharmaceutical packaging workshop is divided into zones The specific zones of pharmaceutical production and packaging environment for cleanliness are in accordance with the national standard of cleanliness 3 Determination of other environmental parameters of the purification project of the packaging workshop 4 The temperature and humidity of the purification project of the packaging workshop, the temperature and relative humidity of the clean room shall conform to the pharmaceutical production process Temperature: 20-23 ~ C for 100 and 10000 grades (summer), 24-26 ~ C for 100000 and 300000 grades, and 26-27 ~ C for general areas Grade 100 and 10000 belong to aseptic room Relative humidity: 45% - 50% for hygroscopic drugs (summer), 50% - 55% for tablets and other solid preparations, 55% - 65% for water needle and oral liquid 5 Clean room pressure to maintain indoor cleanliness needs to maintain a positive indoor pressure For the production of dust, harmful substances, penicillin strong sensitizing drugs and other production of clean rooms to prevent external pollution or areas to maintain a relative negative pressure The inflow of static pressure dyeing and the outflow of internal air in different rooms with different cleanliness levels The positive pressure shall be maintained indoors, and the difference between the room and the adjacent room shall be greater than 5pa, and the static pressure difference between the clean room and the outdoor atmosphere shall be greater than 10Pa.