Views: 0 Author: Site Editor Publish Time: 2025-01-06 Origin: Site
Clean Room is a special type of environmental control in which factors such as the number of particles in the air, humidity, temperature, and static electricity can be controlled to achieve specific cleanliness standards. Clean rooms are widely used in high-tech industries such as semiconductor, electronics, pharmaceutical, aviation, aerospace, and biomedical.
In the Code of Practice for Pharmaceutical Manufacturing, Cleanrooms are divided into four classes, they are A, B, C and D.
Class A: High-risk operating areas, such as filling areas, areas containing corkscrew drums and open packaging containers in direct contact with sterile preparations, and areas of aseptic assembly or joining operations, should be maintained with a unidirectional flow operating table. The unidirectional flow system must provide uniform airflow in its operating area at an air velocity of 0.36-0.54 m/s. Data should be available and verified to demonstrate unidirectional flow status. Lower air velocities may be used in closed isolation manipulators or glove boxes.
Class B: Refers to the background area in which the Class A clean areas for high-risk operations such as aseptic preparation and filling are located.
Class C and D: Clean areas for less critical steps in the production of aseptic drug products.
Class A cleanroom, also known as a class 100 cleanroom or ultra-clean room, is one of the cleanest cleanrooms. It controls the number of particles per cubic foot of air to be less than 35.5, i.e., the number of particles greater than or equal to 0.5um per cubic meter of air should not exceed 3,520 . A class A cleanroom has very strict requirements, and it needs to use high-efficiency filters, differential pressure control, air circulation system, and control system of constant temperature and humidity to realize its high cleanliness requirements. The class A cleanroom is mainly used in microelectronics processing, biopharmaceuticals, precision pharmaceuticals and other precision manufacturing. Class A cleanrooms are mainly used in microelectronic processing, biopharmaceuticals, precision instrument manufacturing, aerospace and other fields.
Class B cleanroom, also known as Class 100 cleanrooms, have a relatively low level of cleanliness, allowing up to 3,520 particles per cubic meter of air greater than or equal to 0.5um (static) and 35,2000 particles per cubic meter of air (dynamic). high efficiency filters and exhaust systems are usually used in Class B cleanrooms to control the humidity, temperature, and differential pressure of the indoor environment. Class B cleanrooms are mainly used in biomedical, pharmaceutical manufacturing, precision machinery and instrumentation manufacturing.
Class C cleanroom, also known as Class 10,000 cleanrooms, have a relatively low level of cleanliness, allowing for 352,000 (static) and 352,0000 (dynamic) particles greater than or equal to 0.5µm per cubic meter of air. Class C cleanrooms usually use high efficiency filters, positive pressure control, air circulation and temperature and humidity control to achieve their specific cleanliness standards. Class C cleanrooms are mainly used in the fields of pharmaceuticals, medical device manufacturing, precision machinery and electronic components manufacturing.
Class D cleanroom, also known as Class 100,000 cleanrooms, have a relatively low level of cleanliness, allowing up to 3,520,000 particles per cubic meter of air greater than or equal to 0.5 um (static). Class D cleanrooms usually use ordinary high-efficiency filters and basic positive pressure control and air circulation systems to control the indoor environment. Class D cleanrooms are mainly used in general industrial production, food processing and packaging, printing, warehousing and other fields.
Different levels of cleanrooms have their own scope of application, according to the actual need to choose to use. In practice, the environmental control of the clean room is a very important task, involving a number of factors for comprehensive consideration, only scientific and rational design and operation, in order to ensure the quality and stability of the clean room environment.
