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How is the clean bench used in pharmaceutical factory production?
How is the clean bench used in pharmaceutical factory production?The vertical flow bench is a kind of equipment that plays an important role in the pharmaceutical field. It is mainly composed of fans, high-efficiency filters, flow-averaging membranes, and other components. In pharmaceutical scenarios, it is widely used in key links such as the filling of sterile drugs, the configuration of injections, and cell culture. Its working principle is to inhale air through the fan on the top, filter it through the high-efficiency filter, remove impurities such as dust, bacteria, and viruses, and then let the clean air blow vertically and evenly to the working area to form a one-way vertical airflow, effectively preventing external pollution from entering the working area.In the pharmaceutical process, why should the airflow and purification parameters of the vertical flow bench be flexibly adjusted according to the drugs? This is because different drugs have different requirements for the cleanliness of the production environment. For example, the production environment requirements of some ordinary oral drugs are relatively low, but the production of drugs such as vaccines and biological products has extremely high requirements for indicators such as the number of microorganisms and dust particles in the environment. If targeted adjustments are not made, the quality of the drugs may not meet the standards, or even safety problems may occur. In terms of airflow adjustment, the fan of the vertical flow bench can usually adjust the wind speed. For the production of ordinary drugs, the wind speed can be set at 0.2-0.3 m/s, which can ensure a certain degree of cleanliness and reduce the operating cost of the equipment. When producing highly sensitive drugs, such as cell therapy products, the wind speed can be increased to 0.4-0.5 m/s, so that the airflow can more efficiently remove possible pollutants. In the adjustment of purification parameters, the key lies in the selection of high-efficiency filters. High-efficiency filters have different filtration levels, and the filtration efficiency ranges from 99.9% to 99.999%. For the production of general drugs, a high-efficiency filter with a filtration efficiency of 99.9% can be selected, and the number of dust particles can be controlled at about 500 per cubic meter. For the production of drugs with extremely high cleanliness requirements such as genetically engineered drugs, a high-efficiency filter with a filtration efficiency of 99.999% is required, which can reduce the number of dust particles to less than 10 per cubic meter. In addition, the airflow distribution inside the workbench can be fine-tuned according to the specific process and operation area of drug production. For example, when performing local high-risk operations, the airflow can be concentrated in the operation area by installing guide plates and other methods to enhance the local purification effect. In short, in the pharmaceutical process, flexibly adjusting the airflow and purification parameters of the vertical flow workbench according to the characteristics of the drug is crucial to ensuring the quality and safety of the drug. |
