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How does a Class 100 laminar flow hood work in a GMP pharmaceutical factory?
How does a Class 100 laminar flow hood work in a GMP pharmaceutical factory?The purpose of pharmaceutical factories requiring the implementation of GMP (Good Manufacturing Practice) is to ensure that all aspects of the entire pharmaceutical production process are governed by regulations, standards, and other documents. There are many factors that affect the quality of pharmaceuticals. Only well-trained personnel, using qualified raw and auxiliary materials and production equipment in factory facilities that meet production conditions, adopting correct and verified production methods, and passing reliable inspections can ensure the quality of the products produced. It's believable.Class 100 laminar flow hood is a commonly used equipment in GMP-standardized pharmaceutical factories. How does it ensure the quality of drugs? The 100-level laminar flow hood is mainly composed of a hood body, a fan, a high-efficiency filter, and a control system. Its working principle is to inhale air through a fan and filter it through a high-efficiency filter. Generally speaking, the filtration efficiency of high-efficiency filters can reach more than 99.999%, and can effectively filter out particles, bacteria, dust, and other pollutants in the air with a diameter of 0.3 microns and above. Taking the common 100-level laminar flow hood with dimensions of 1200mm×600mm×300mm as an example, the air volume of the fan is usually 1000-1500 cubic meters/hour. When the air passes through the high-efficiency filter, it will be sent out in a uniform laminar flow state. The airflow speed in the laminar flow hood is generally maintained at 0.3 - 0.5 meters/second. This speed can ensure that possible pollutants can be quickly taken away without causing interference with the pharmaceutical production process. For example, in the pharmaceutical potting operation area, the clean air flow blown out by the 100-level laminar flow hood can form a local clean environment. The airflow blown evenly from above will form an "air barrier" around the work surface, preventing unfiltered air from outside from mixing in. In actual work, the Class 100 laminar flow hood maintains a positive pressure state within the hood relative to the external environment through its internal pressure control system. Normally the positive pressure difference is maintained at 10 - 15 Pascals. This ensures that even if there are air pressure fluctuations caused by people moving around or equipment opening and closing, the surrounding air containing impurities can still be prevented from entering the working area of the laminar flow hood. At the same time, the 100-level laminar flow hood is also equipped with a monitoring system. Air quality and airflow status are monitored in real-time through equipment such as dust particle counters and wind speed sensors installed in the hood. If abnormal conditions such as the number of dust particles exceeding the standard or unstable airflow speed are found, the system will issue an alarm in time. For example, when the dust particle counter detects that the number of particles larger than or equal to 0.5 microns per cubic meter of air exceeds 3,500 (class 100 cleanliness standard), an alarm will sound to remind staff to perform inspection and maintenance. |
