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What Is The Concept Of GMP Class 100,000 Cleanroom

  • 2022-07-28
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GMP class 100,000 cleanroom, Good Manufacturing Practice (GMP), which means "Good Practice" or "Good Manufacturing Standard", is an autonomous management system that focuses on the quality and safety of products in the production process. It is an autonomous management system that focuses on product quality and health and safety during the production process.

What Is The Concept Of GMP Class 100,000 Cleanroom

In a cleanroom, the production conditions meet certain temperature and humidity requirements, and the air quality parameters such as the number of dust particles and the number of settling bacteria and planktonic bacteria reach a certain level. And the purification workshop floor, wall, ceiling, lights and other facilities and equipment should meet certain standards, to create a production environment that is easy to clean, no sanitary corners, no dust, no chips as the basic conditions. Mostly seen in pharmaceutical and electronic factories, the operating room also has the same basic requirements.

What is the concept of class 100,000 cleanroom?

The cleanroom is widely used in food and medicine, and there are also a lot of technology accessories that need to be finished in the cleanroom, but the cleanroom is divided into ten thousand levels, do you know what is GMP hundred thousand level cleanroom?

GMP is a set of mandatory standards for pharmaceutical and food industries, requiring enterprises to meet health quality requirements from raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control and other aspects in accordance with national regulations, forming a set of operational specifications to help enterprises improve their health environment, and timely detection of problems in the production process, to improve.

Briefly, GMP requires food manufacturers to have good production equipment, reasonable production process, perfect quality management and strict testing system to ensure that the quality of the final product (including food safety and hygiene) meets the regulatory requirements.

According to the standards issued by the U.S. federal government, the GMP cleanroom can be divided into 4 levels. If the grade of GMP cleanroom is described only by the number of dust particles, it can be assumed that the size of dust particles is 0.5um.

For example, the maximum number of dust particles in a class 100 GMP cleanroom is less than or equal to 100, if the dust particle size is not 0.5µm, the GMP cleanroom class should be expressed in terms of the number of classes in a particular dust particle size.

In order to maintain the cleanliness of the clean room, there are certain dressing regulations for the personnel entering and leaving; for class 10,000 and 100,000, you must wear a long robe, dust-free clothes, dust-free shoes, hat and mask; for class 1000 (inclusive) and above, you need to wear a special clean jumpsuit, dust-free shoes to wrap your whole body, and gloves and mask, and all production processes are isolated from the outside world. The lowest level is 100,000, and the clean room with 100 levels is the clean room with the highest cleanliness at present.

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