Joke Collection Website - Bulletin headlines - What are the cleanliness levels of sterile area, clean area and control area in pharmaceutical enterprises respectively?
What are the cleanliness levels of sterile area, clean area and control area in pharmaceutical enterprises respectively?
General purification grades are 100, 1000, 10000, 100000. Now the 20 10 version of GMP is no longer called this in purification workshop, and it is divided into ABCD levels, corresponding to several levels of the 98 version. By detecting the number of dust particles in this area,
Clean room refers to a specially designed room that removes particulate matter, harmful air, bacteria and other pollutants in the air within a certain space range, and controls indoor temperature, cleanliness, indoor pressure, airflow speed and airflow distribution, noise and vibration, lighting and static electricity within a certain demand range. In other words, no matter how the outside air conditions change, the room can maintain the original requirements of cleanliness, temperature, humidity, pressure and so on. Dust-free workshop can be divided into the following grades:
1 class clean workshop is mainly used to manufacture integrated circuits in microelectronics industry, and the accuracy of integrated circuits is required to reach submicron level.
10 clean workshop is mainly used in semiconductor industry with bandwidth less than 2 microns.
100 class Many people think that this kind of clean room is the most commonly used and therefore the most important one. People often mistakenly refer to 100 clean room as sterile room to explain the "aseptic" or "clean" environmental requirements. 100 clean room can be used for aseptic production process in pharmaceutical industry. This kind of clean room is widely used for implanting objects in the body.
1000 clean workshop is mainly used to produce high-quality optical products, as well as to test and assemble aircraft snake snail meters and assemble high-quality miniature bearings.
10000 clean room is used for the assembly of hydraulic equipment or pneumatic equipment, and in some cases it is also used in food and beverage industry. In addition, 10000 clean rooms are also commonly used in the medical industry.
1000000 100000 clean workshop is used in many industrial sectors, such as the manufacture of optical products, the manufacture of large electronic systems with smaller components, the manufacture of hydraulic or pneumatic systems, the production of food and beverages, and it is often used in medical and pharmaceutical industries.
The above is provided by Anhui Renhe Purification.
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