Class 100,000 clean workshop is equivalent to Class C or Class D and what can be produced in Class 100,000 clean workshop1

The clean workshop is mainly to remove particles, harmful air, bacteria and other pollutants in the air within a certain space, and control the indoor temperature, cleanliness, indoor pressure, airflow speed and airflow distribution, noise, vibration, lighting, and static electricity. Within a certain demand range, to ensure that the product can be produced and manufactured in a stable and good environment. Let's take a look at what can be produced in a 100,000-class clean pharmaceutical cleanroom, which is equivalent to a C-class or a D-class and a 100,000-class clean workshop. Particles and microorganisms are the main control objects, and the air cleanliness level is specified as the following four levels: A-level area: high-risk operation areas, such as filling areas, areas where rubber stoppered barrels and open ampoules are placed, open vials, and Areas for aseptic assembly or connection operations. A laminar flow stage (hood) is usually used to maintain the environmental conditions of the zone. The laminar flow system must supply air evenly in its working area, and the wind speed is 0.36--0.54M/S, (guidance value). There should be data proving the state of the laminar flow and verified. In closed isolated operating areas or glove boxes, one-way flow or lower wind speeds may be used. B-level area: refers to the background area where the A-level area for high-risk operations such as aseptic preparation and filling is located. C-level area and D-level area: refer to the less important clean operation area in the process of producing sterile drugs. A-level and B-level are equivalent to 100-level. A-level has a higher background environment and stricter requirements. C-level is equivalent to 10,000, and D-level is equivalent to 100,000. 2. What can the 100,000-level clean workshop produce? The 100,000-level clean workshop is widely used in food, medicine, cosmetics, etc. In addition, there are many scientific and technological accessories, all of which need to be completed in the purification workshop, but the purification pharmaceutical cleanroom is divided into two parts. 10,000-level, do you know what a GMP 100,000-level purification workshop is? GMP is a set of mandatory standards applicable to the pharmaceutical, food and other industries. In other aspects, according to the relevant national laws and regulations to meet the quality requirements of hygiene, to form a set of operational norms to help enterprises improve the hygiene environment of enterprises, timely detection of problems in the production process, to improve. Briefly, GMP requires that food production enterprises should have good production pharma machinery, reasonable production process, perfect quality management and strict inspection system to ensure that the quality of the final product (including food safety and hygiene) meets the regulatory requirements. According to the standards promulgated by the US federal government, the GMP purification workshop can be divided into six levels. They are grade 1, grade 10, grade 100, grade 1000, grade 10000, and grade 100000. If the grade of the GMP purification workshop is only described by the number of dust particles, the size of the dust particles can be assumed to be 0.5um. For example, the maximum number of dust particles in Class 1, Class 10 and Class 100 GMP purification workshops is less than or equal to 1 particle, 10 particles and 100 particles respectively. If the dust particle size is not 0.5µm, the GMP purification workshop grade should be based on a specific dust particle size. to represent the series. In order to maintain the cleanliness of the clean workshop, personnel entering and leaving have certain dress regulations; Class 10000 and 100000 must wear robes, clean shoes, hats and masks; Class 1000 (inclusive) and above, special clean clothes must be worn. Jumpsuits and clean shoes will cover the whole body, and wear gloves and masks, and all production processes are completely isolated from the outside world. The lowest level is the class 100,000 clean room, and the class 100 clean room is the clean room with the highest cleanliness.

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