German
French
Italian
Portuguese
Japanese
Korrean
Russian
Pharmaceutical industry requirements for laminar flow hoods
Pharmaceutical industry requirements for laminar flow hoods(I) Cleanliness level requirementsIn the pharmaceutical industry, different clean area levels have different requirements for laminar flow hoods. Class A areas are high-risk operation areas, such as filling areas, areas for placing stopper barrels, open ampoules, open vials, aseptic assembly lines or connection operation areas, etc., and laminar flow hoods are usually used to maintain the environmental state. The laminar flow system must evenly supply air in its working area, with a wind speed of 0.36 - 0.54m/s (guideline value). To confirm the level of Class A clean areas, the sampling volume of each sampling point shall not be less than 1 cubic meter. The level of air-suspended particles in Class A clean areas is ISO4.8, limited to suspended particles ≥5.0μm. Class B areas, as background areas for high-risk operations such as aseptic preparation and filling, also have high requirements for laminar flow hoods. Class C and Class D areas are low-importance clean operation areas in the production of sterile drugs, but they also require laminar flow hoods to ensure a certain degree of cleanliness. For example, in the Class A clean area of a large pharmaceutical company, the efficient operation of the laminar flow hood keeps the cleanliness of the area at an extremely high level, ensuring the quality and safety of drug production. (II) Environmental parameter requirements The pharmaceutical industry has strict requirements for the environmental parameters of laminar flow hoods. In terms of air temperature, the air temperature of Class A, Class B, and Class C clean areas should be 20-24℃, and the air temperature of Class D clean areas should be 18-26℃. Such a temperature range can provide a suitable environment for drug production and ensure the stability and quality of drugs. In terms of relative humidity, the relative humidity of the air in the clean working area should be 45%-60%. Within this humidity range, it can effectively prevent drugs from getting damp or too dry, ensuring the efficacy and quality of drugs. The wind speed requirements are strict, the horizontal wind speed in the clean working area is ≥0.54m/s, and the vertical wind speed is ≥0.36m/s. The appropriate wind speed can ensure the flow and purification effect of air and create a good air environment for drug production. In terms of pressure difference, the pressure difference between clean areas of all levels relative to the outdoors is ≥10PA and different areas of the same level should maintain a certain pressure difference according to the airflow. The existence of pressure differences can prevent cross-contamination between different clean areas and ensure the safety of drug production. The leak detection of high-efficiency filters is greater than 99.97%. The high-efficiency filter is the core component of the laminar flow hood. Its strict leak detection requirements are to ensure the filtering effect and prevent impurities in the air from entering the drug production area. In terms of lighting, the requirement is > 300LX - 600LX. Adequate lighting can facilitate the work of operators and improve production efficiency and quality. Noise ≤75db (dynamic test). A low-noise environment can provide operators with a comfortable working environment and reduce the interference and impact of noise on operators. |
