What Is The Standard For A Class 100000 Clean Production Workshop
- 2024-03-05
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Class 100000 Clean Production Workshop is a cleanroom commonly used in general industrial production and is widely used in food, cosmetics, electronics, semiconductor, printing, automotive, aerospace, lithography, microcomputer manufacturing and other fields. But there are many people do not understand what is Class 100000 Clean Production Workshop the following concise introduction of 100,000 class cleanroom knowledge and standards.
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Class 100000 Clean Production Workshop is defined by the number of dust particles and the number of microorganisms, the maximum number of dust particles allowed to be greater than or equal to 0.5 microns shall not exceed 350,000 particles, and the number of particles greater than or equal to 5 microns shall not exceed 2,000, Class 100,000 cleanroom standard is equivalent to ISO standard class 8. In the GMP standard: no more than 3520000 dust less than or equal to 0.5μm per cubic metre of air, no more than 20,000 dust less than or equal to 5μg, no more than 500 floating bacteria per cubic metre of air, and no more than 10 sinking bacteria per vessel.
In the ISO international standard: ≥0.5μm dust per cubic metre not more than 3520000, ≥1μm dust not more than 832000, ≥5μm dust not more than 29300.
One hundred thousand cleanroom standard is from the industry standard can be understood as the standard of cleanliness, the general cleanliness level is usually divided into ten, one hundred, one thousand, ten thousand, one hundred thousand, three hundred thousand!
In terms of the number of air changes:
Class 100,000 requires 18-25 air changes per hour, with an air purification time of no more than 40min after a complete air change.
The class 10,000 requires 25-30 air changes per hour and the air purification time does not exceed 30 minutes after a complete air change.
Thousands of levels require 40-60 air changes per hour, and the air purification time does not exceed 20min after complete air changes.
Cleanroom structure materials
1). Structure part of the general plant wall, top plate more use 50mm thick sandwich color steel plate manufacturing, its characteristics are beautiful, rigid, good insulation performance, easy construction. Rounded corners, doors, window frames, etc. are generally made of special purification profiles.
2). The floor adopts epoxy self-flowing flooring or high-level wear-resistant plastic flooring with anti-static requirements.
3). The air supply and return ducts are made of hot ducted zinc plates, and the flame-retardant PF foam plastic plates with good purification and heat preservation effect are attached.
4). The air supply outlet is sheared and welded with cold-rolled plate into a static pressure box and then sprayed with plastic, then inlaid and fixed with high efficiency filter, beautiful and clean, and the perforated mesh plate is made of baked aluminium, which is not rusty and not sticky and suitable for cleaning.
Clean Purification workshop principle
Generally have to go through three filtration sections such as primary filtration, middle-effect filtration and high-efficiency filtration. Air flow → primary purification → humidification section → heating section → table cooling section → medium-effect purification → fan air supply → duct → high efficiency purification air outlet → blow into the room → take away dust bacteria and other particles → back to the air shutters → primary purification Repeat the above process, you can achieve the purpose of purification.
Class 100000 Clean Production Workshop standards
1. Maximum permissible number of dust particles (per cubic metre); the number of particles greater than or equal to 0.5 microns shall not exceed 3500000, and the number of particles greater than or equal to 5 microns shall not exceed 20000.
2. Maximum permissible number of micro-organisms; the number of floating bacteria shall not exceed 500 per cubic metre, and the number of sunken bacteria shall not exceed 10 per petri dish.
3. Pressure difference: the same cleanliness level of the cleanroom pressure difference to maintain consistent, different cleanliness level of the adjacent cleanroom pressure difference between the workshop to ≥ 5Pa, cleanroom and non-cleanroom to ≥ 10Pa.
In fact, it is quite difficult and expensive to set up an "extremely clean room" and to ensure that the cleanliness level is up to standard all the time. This is because to achieve a 'Class 100,000' level of cleanliness involves validation of the clean air conditioning system, validation of the clean water system, high frequency testing of airborne dust particles, sinking bacteria, floating bacteria, on-site management and maintenance of clean area equipment and material cleaning and disinfection, etc. The workshop environment is controlled through high frequency filtration regular air exchange and ozone sterilisation, and highly rigorous processes and procedures are used to ensure a highly clean production environment that is free of staining, dust and bacteria. It is not an exaggeration to say that the water used for washing clean clothes in the cleanroom is cleaner than the distilled water used for drinking, truly achieving "pharmaceutical grade cleanliness".
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