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Pharmaceutical factory 100-level work area core role
Pharmaceutical factory 100-level work area core role(1) Extreme cleanliness, refusing to polluteThe 100-level working area can control the number of dust particles and microorganisms at a very low level, relying on two "magic weapons". The first is the high-efficiency air filtration system, the layer of filter to make a "deep clean" to the air, from the coarse filter, the large particles of impurities first stop, to the medium filter, further screen the medium-sized dust, and finally through the high-efficiency filter, even the extremely small, micron level dust particles are difficult to hide, to ensure that the air into the work area is clean. The second is the strict personnel and material control process. Before entering, the personnel has to go through a series of "checkpoints": First in the locker room to change from head to toe sterile protective clothing, masks, and gloves, and the dust microorganisms they may carry are "sealed" up; Then through the air shower, the strong airflow from all directions to blow, the residual dust of the body swept away; Materials, but also after cleaning, disinfection, transfer window layer by layer "check", to enter this "sacred" hundred level area. Let's take the production of sterile drugs, like the potting process of injections, which is the "critical moment" of direct contact with the inside of the drug. If at this time there a dust particles or microorganisms "mixed" in, the drug is contaminated, and injected into the patient's body, the consequences are unimaginable and may cause serious adverse reactions, and even life-threatening. The 100-level work area is like adding a "super shield" to drug production to avoid this "disaster" to the greatest extent. (2) Accurate environmental control to ensure the stability of drug effects In addition to cleanliness, the 100-level working area is also quite "proficient" in the regulation of environmental factors such as temperature, humidity, and air pressure. The temperature is generally stable and controlled at 18-26 ° C, the humidity is maintained at 45%-65%, and the air pressure is positive pressure relative to the surrounding low-grade area. Why is it so elaborate? Because the drug is like a "delicate baby", the environment is slightly not dealt with, it may "lose temper" - deterioration or damage to the active ingredient. For example, biological products, many of which contain protein and other components sensitive to temperature and humidity, the temperature is high, the protein denaturation, the drug will fail; The humidity is too high, the medicine gets damp, microbes grow, and that's it. Look at the production of injections, if the environmental pressure is unstable, the external unclean air "enters", and the pollution of drugs is a matter of minutes. Therefore, the 100-level area is maintained at all times through precision air conditioning systems, air pressure regulation devices, etc. |
