What is the standard for dividing the clean area into ABCD level?
The background often receives inquiries from customers that the pharmaceutical factory needs C-level clean clothes, so what is the difference between the ABCD level and the hundreds and thousands of levels we usually know? Class A, B, C, and D clean areas in the new version of GMP, generally A-level areas represent 100-level clean areas, B-level areas represent 10,000-level clean areas, C-level areas represent 100,000-level clean areas, and D-level areas represent 300,000-level clean areas.
Generally, it can be divided into the following four levels: A-level high-risk operation areas, such as: filling area, area for placing rubber stopper barrels, open ampoules, open vials, and areas for aseptic assembly or connection operations. A laminar flow console (hood) is usually used to maintain the ambient conditions in the area. The laminar flow system must deliver air evenly in its working area, with a wind speed of 0.360.54m/s (guideline value). Data shall be available to demonstrate the state of laminar flow and shall be verified. In a closed isolator or glove box, one-way flow or lower air speeds may be used. Class C and Class D refer to clean operation areas with low importance in the process of producing sterile drugs.
In addition, the air in the clean area, also known as the air in the clean room, refers to the air in the regional space where the suspended particles and the number of microorganisms are controlled within a certain range. The cleanliness of the air can be divided into different grades, and the cleanliness of the air for various scientific research and production activities is also different. For example, in bacterial culture and cell culture, the air cleanliness is relatively high. These experimental operations are generally performed in ultra-clean benches. We can consider the air in ultra-clean benches to be close to sterile.