In the core area of pharmaceutical production - the clean room, the clean air conditioning system is like a silent "health guardian", creating a suitable temperature, humidity and clean environment for drug manufacturing. However, just like precision instruments that often encounter malfunctions, this system also suffers from numerous thorny problems, which are related to the "lifeline" of drug quality and the "stability line" of enterprise production.

Pharmaceutical clean rooms have extremely high requirements for air cleanliness. Primary, intermediate and high-efficiency filters are set up layer by layer to intercept "uninvited guests" such as dust, particulate matter and microorganisms. However, under long-term operation, the filters are often the "hardest hit areas". The residual dust from workshop construction, the fine dust volatilized from production materials, and the dander and hair raised by the frequent movement of personnel continue to accumulate, gradually blocking the pores of the filters. Once blocked, the air supply volume will be greatly reduced, the static pressure in the workshop will be out of balance, and the local cleanliness will "decline". Drugs will be exposed to an environment with excessive dust beyond the standard, and the risks of microbial contamination and impurity mixing will soar, which is a fatal blow to the sterility of injections and the purity of oral solid preparations. For example, in the production workshop of freeze-dried vaccines, if tiny dust "mixes in" during the freeze-drying process, it will damage the freeze-dried form of the vaccine and the uniformity of the active ingredients, resulting in inaccurate drug efficacy and a significant reduction in the immune effect.

The clean air conditioning system is responsible for precisely controlling the temperature, but the refrigeration and heating components often "fail". On the refrigeration side, the compressor is the "heart". Under the long-term high-load refrigeration to deal with the heat generated by the workshop and the operation of equipment, it is prone to fatigue and wear, and refrigerant leakage and poor heat dissipation of the condenser also occur frequently. In hot summer, when the refrigeration fails, the temperature in the workshop will soar, and the activity of heat-sensitive drugs (such as some probiotic preparations and enzyme drugs) will be damaged and the deterioration will accelerate. On the heating side, the aging of heating elements and the malfunction of thermostats will make it unable to maintain a warm temperature in cold winter. The viscosity of the glue solution for soft capsule molding will become abnormal in the cold, affecting the quality and specifications of soft capsules. Moreover, large temperature fluctuations will cause the expansion and contraction of pipes, resulting in loose connections and refrigerant leakage, and the maintenance costs and production stoppage losses will "rise steadily".

Humidity control is a "key part" of the air conditioning system, but it is easy to fall into the quagmire of "disorder". During dehumidification, problems such as frost blockage of the condenser tubes and abnormal rotation speed of the desiccant wheel of the desiccant wheel dehumidifier will lead to ineffective dehumidification, and the humidity in the workshop will exceed the standard. Metal equipment will rust and corrode, and paper packaging materials will become damp and softened. What's more serious is that when the humidity in the workshops for processing traditional Chinese medicine decoction pieces and synthesizing biochemical drugs gets out of control, the raw materials will absorb moisture and become moldy, and the chemical reactions will deviate from expectations, resulting in defective products and waste materials. In the humidification process, problems such as the nozzle of the steam humidifier being clogged with scale and the electrodes of the electrode humidifier being corroded and damaged will cause the humidity to be lower than the standard. A dry environment will cause drugs to crack and static electricity to occur frequently, attracting dust. Static electricity sparks may even threaten the safety of the storage area for flammable and explosive solvents, laying a "time bomb" for pharmaceutical production.

The fan is like the "power engine" of the air conditioning system, ensuring the continuous circulation and even distribution of air. However, under long-term operation, problems such as wear and deformation of the impeller, lack of oil, wear and overheating seizure of the bearing are common. The problems of the impeller will cause uneven air volume and unstable air pressure, and the corners of the workshop will become "ventilation dead corners", where clean air is difficult to reach, and dust and microorganisms will "take root" here. The problems of the bearing will cause abnormal vibration and noise, interfering with the normal operation of precision instruments and equipment in the workshop. Pharmaceutical enterprises have to suspend the production line to repair the fan in order to ensure production and protect equipment, which is time-consuming, laborious and causes huge losses.

The complex pipeline is the "blood vessel" of the air conditioning system, transporting cold and warm air and clean air, but it has hidden leakage risks. The welding joints of the pipeline may crack due to installation flaws and long-term vibration stress, and the sealing gaskets at the flange connections may age and lose elasticity due to the erosion of temperature and humidity, resulting in the leakage of refrigerant, cold and warm air. On the one hand, refrigerant leakage will disrupt the refrigeration and heating cycle, and the temperature and humidity in the workshop will get out of control. On the other hand, unpurified external air will "sneak in" through the leakage points, carrying dust and bacteria, breaking the cleanliness of the workshop and making the guarantee of drug quality "fall short".

The problems of the clean air conditioning system in pharmaceutical clean rooms are interrelated and have far-reaching impacts. Pharmaceutical enterprises need to strengthen daily inspections and regular maintenance, and cooperate with professional purification equipment suppliers to build a "health defense line" for the system with technology and meticulous management, so as to escort the quality of pharmaceuticals and safe production.