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Application scenarios of laminar flow hoods in pharmaceutical factories
Application scenarios of laminar flow hoods in pharmaceutical factories(I) Specific production linksIn pharmaceutical factories, the filling, subpackaging, and sealing of sterile injections have extremely high requirements for environmental cleanliness. In these links, any tiny particles or microorganisms may have a serious impact on the quality of drugs. For example, in the filling process of sterile injections, the laminar flow hood can ensure that the air passes through the high-efficiency filter at a specific wind speed to form a uniform flow layer, so that the clean air flows vertically and unidirectionally, providing a stable high-cleanliness environment for drug filling. In the subpackaging link, the laminar flow hood can effectively prevent the entry of external particles and microorganisms to ensure the purity of the drug. In the sealing link, the laminar flow hood also plays a key role, preventing contamination while ensuring the sealing of the drug. For the production of biological products, such as filling, freeze-drying, and sealing, laminar flow hoods are also indispensable. Biological products usually have more stringent requirements on the environment because their active ingredients are more susceptible to external factors. Laminar flow hoods can provide a local high-cleanliness environment for these links to ensure the quality and stability of biological products. (II) Areas with different cleanliness levels The clean area of a pharmaceutical factory is generally divided into four cleanliness levels: 300,000, 100,000, 10,000, and 100. Among them, the 100-level area is the highest cleanliness level, usually located in the inner area of the workshop, surrounded by the 10,000-level area or the 100,000-level area. As part of the workshop assembly line, the 100-level area plays a vital role in the entire production process. In the 100-level area, laminar flow hoods are usually used to maintain the environmental state. According to relevant regulations, Class A clean areas (equivalent to Class 100), such as filling areas, areas where rubber stopper barrels, open ampoules, open vials, and aseptic assembly lines or connection operations, usually use laminar flow operating tables (hoods) to maintain the environmental state of the area. The laminar flow system must evenly supply air in its working area, with a wind speed of 0.36-0.54M/S (guide value). Under the action of the 100-level laminar flow hood, the level of airborne particles can reach ISO 4.8, with suspended particles ≥5.0μm as the limit standard. At the same time, the laminar flow hood can also effectively control the temperature, relative humidity, wind speed, and other parameters of the Class 100 area to meet the strict production requirements of the pharmaceutical factory. For example, the air temperature in the Class 100 area should be 20-24℃, the relative humidity should be 45%-60%, and the vertical wind speed should be ≥0.36m/s. |
