Clean room common sense

MentionCleanroomMany people's impressions may be a lot of breath, manage strict space. What is clean room? What is its principle? Next, Shandong Xinli Xiaobian took everyone to find out.

In a pharmaceutical sense, the clean room refers to a room that meets GMP (Good Manufacture Practice of Medical Products, GMP) sterile specification. Due to the demanding requirements of manufacturing technology upgrades to the production environment, clean laboratories are also known as \"The Guardian of High-end Manufacturing\".

what isCleanroom？

Clean rooms can also be called clean room, which is often used as part of professional industrial production or scientific research, including manufacturing drugs, integrated circuits, CRT, LCD, OLED, and Microled displays. The clean room is designed to maintain extremely low levels of particles such as dust, aerosol in the air, or vaporized particles. Specifically, the clean room has a controlled contamination level, which is specified by the number of particles per cubic meter under the designated particle size. Clean chambers can also refer to any given receiving space, setting reduced particulate contamination and controlling other environmental parameters, such as temperature, humidity, and pressure, and the like in this space.

In a pharmaceutical sense, a clean room refers to a room that meets the GMP specifications defined in GMP Sterile Norms (ie EU and PIC / S GMP Annex 1 and other standards and guidelines required by local health authorities. A combination of engineering design, manufacturing, completion, and operational control (control strategy) required for clean room.

Many industries use a clean room, as long as the small particles will adversely affect the production process, there will be a jade room. Their size and complexity are different, widely used in semiconductor manufacturing, pharmaceutical, biotechnology, medical equipment and life sciences and other industries, as well as common key processes such as aerospace, optical, military and energy.

CleanroomAir flow principle

Clean room airflow principle: Clean room by using HEPA (Ultra Low Penetration Air Filter) filter, using laminar (single-way stream Laminar Flow) or turbulence (Swift current, non-one The flow of the flow of air flow is to control the particles in the air. The laminar or one-way airflow system converts the filtered air in a constant flow down or horizontal direction into a filter on the wall near the clean chamber floor, or recycled by the projection. Lamination air flow systems are typically used by 80% of the clean room ceiling to maintain constant air. Stainless steel or other non-fallwest materials are used to construct laminar flow filters and hoods to prevent excess particles from entering air.

Turbulence, or non-single air flowing using a laminar air flow cover and a non-specific speed filter to maintain the air in the clean chamber at a constant movement, although not all the direction is the same. Rough air attempts to capture particles that may exist in the air and drive them on the floor, they enter the filter and leave the clean room environment.

Some places will also increase the vector clean room: air in the upper corner of the room, using a sector high-efficiency filter, you can also use the ordinary high-efficiency filter with a fan-shaped air outlet, set back to the air in the lower side, the room is high The length is generally between 0.5 and 1. This clean room can also reach level 5 (level 100) clean degree.