Several articles are extracted from the full text of GMP2010: Article 9: The clean areas required for the production of sterile drugs can be divided into the following four levels: Class A: High-risk operating areas, such as filling areas, areas where plastic stopper drums are placed and open packaging containers in direct contact with sterile preparations, and areas for aseptic assembly or joining operations, should use a one-way flow table (cover) ) Maintain the environmental status of the area. The unidirectional flow system must deliver air uniformly in its working area with a wind speed of 0.36-0.54 m/s (guide value). There should be data to prove the state of the one-way flow and verified. Class B: Refers to the background area where high-risk operations such as aseptic preparation and filling are in Class A clean areas. Grades C and D: Refers to the clean areas of the less important operating steps in the aseptic manufacturing process. The standards for air suspension particles of the above various levels are as follows: (2) When confirming the level, a portable dust particle counter with a short sampling tube should be used to avoid the sedimentation of ≥5.0 μm suspended particles in the long sampling tube of the remote sampling system. In a unidirectional flow system, an isokinetic sampling head should be employed. (3) The dynamic test can be carried out in the normal operation and medium simulation filling process, which proves that the dynamic cleanliness level is reached, but the medium simulation filling test requires dynamic test under the “worst conditionâ€. The cleanliness requirements are as follows: 1. Area B is the background area of ​​Area A. Area B is a hundred-level area. Area A is level 10 or level 1, but must be a one-way flow device, such as a clean bench, an isolator, and so on. Equipment supply Equipment in Zone A: Because the isolator is too expensive, it is not necessary. Generally, the pharmaceutical company will purchase a one-way flow vertical type ultra-clean platform. The domestic ultra-clean platform can achieve one-way flow in a new size of 1.1 meters and below, but it is large. Part of the cleanliness is 100 grades, which does not meet this requirement; most of the domestic super clean benches above 1.1 meters use the filter splicing method to do laminar flow filtration, and the non-unidirectional flow does not match; the domestic super clean bench almost does not use the wind speed sensor to track the machine. The actual wind speed is corrected to ensure stable performance of the clean bench. The clean bench in Zone A needs: a unidirectional flow vertical clean bench with a wind speed sensor and a monolithic filter. For example, 2264 and 2266 models imported and assembled by BioX Technology's China plant have been used in well-known domestic pharmaceutical companies: New Drug Safety Evaluation Center, Beijing Ganli Pharmaceutical, Heilongjiang Kina Herris (USA), Hainan General Kangli, Jiangsu Yingteli (Italy) and so on. (Model: 2266) Class B is 100: If it takes time to decorate a clean room, it will take a lot of money to maintain the requirements of the 100th class. There is a kind of equipment "clean shed (room)" in the market, which fully meets the requirements of 100 grades. It can be anti-static soft curtain or stainless steel plate, which can be customized according to customers' requirements. It is so capricious. (Model: 3202) The cleanliness requirements of Zone C and Zone D are low, the area is large, and the decoration room meets the requirements. The CMA unit (Shanghai 021-58153966) is certified for measurement. To sum up: drug safety regarding human health and life, we must strictly follow the GMP2010 to regulate production enterprises. US BioX Technology Co., Ltd. China's imported assembly plant's biological safety cabinet, ultra-clean platform, clean shed, odor analysis table, vacuum-type ultra-clean platform, ductless fume hood, etc., is willing to serve Chinese pharmaceutical companies. China Foldable Stretcher,Medical Rescue Folding Stretcher,Rescue Folding Emergency Stretcher,Emergency Portable Stretcher, we offered that you can trust. Welcome to do business with us. Foldable Stretcher,Medical Rescue Folding Stretcher,Rescue Folding Emergency Stretcher,Emergency Portable Stretcher Medton Medical , https://www.medtonmedical.com
Lower wind speeds can be used in a closed isolation operator or glove box.
Note: (1) In order to confirm the level of Class A clean area, the sampling amount of each sampling point shall not be less than 1 cubic meter. The level of airborne particles in the Class A clean zone is ISO 4.8, with a limit of ≥5.0 μm suspended particles. Class B clean areas (static) have airborne particles of the class ISO 5 and include suspended particles of two particle sizes in the table. For Class C clean areas (static and dynamic), the levels of airborne particles are ISO 7 and ISO 8. For Class D clean zone (static) airborne particles are rated ISO 8 . The test method can be referred to ISO 14644-1.
2. Area C is 10,000 and 100,000.
3. The D area is 100,000. 
Cleanliness level
Maximum allowable number of suspended particles / cubic meter
Static
Dynamic (3)
≥0.5μm
≥5.0μm (2)
≥0.5μm
≥5.0μm
Class A (1)
3520
20
3520
20
Class B
3520
29
352000
2900
Class C
352000
2900
3520000
29000
Class D
3520000
29000
Not regulated
Not regulated