Cosmetics Gmp Clean Workshop Design
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The cosmetics GMP clean workshop is a specific requirement for the factory equipment, environment, personnel, hygiene management/control and other software and hardware of the manufacturer based on the characteristics of the cosmetics.
The "Code of Work for Cosmetics Production Licensing" issued by the State Food and Drug Administration after the "two certificates are combined into one" points out: for the production of eye skin, baby and children skin care cosmetics, the filling room and clean container storage room of the production workshop The air cleanliness should reach 300,000 class requirements.
Of course, each cleanliness level has its own purpose. The company can define a reasonable cleanliness level for each workshop according to the scale and project of the production. The premise is that the total number of bacteria in the air of the production workshop cannot exceed 1000/m3. At the same time, semi-finished products The storage room, filling room, clean container storage room, changing room and its buffer zone must have air purification or air disinfection facilities.
In this way, companies will also save a lot of costs or resources. Now most cosmetics companies will also build factories in accordance with 100,000 cleanliness.
The routine inspection content of cosmetics testing includes: physical and chemical indicators, sensory indicators, total number of bacteria in sanitary indicators, weight indicators and appearance requirements. The more detailed testing content also includes: heavy metal testing, microbial testing, preservative testing, active substance content testing and Other toxicological testing and analysis items such as prohibited substances. Only by perfecting the inspection of the cosmetics production plant itself can it calmly face the task of random inspection by the relevant state supervision departments before the circulation and listing.
For example, Kwang Cleanroom, a clean engineering integrator service provider, during the construction of a cosmetics production plant project, the designer of Kwang Cleanroom made the following planning and design for the construction of the cosmetic laboratory:
1. About the division of Cosmetics Gmp Clean Workshop: gas chromatography room, liquid chromatography room, atomic spectroscopy room, chemical cosmetic sample storage room, microbiological experiment validity and preparation room, office management and data processing room, sample pretreatment room, Room for UV-Visible spectroscopy and analytical balance room for prohibited substances.
2. Regarding the cleanliness of Cosmetics Gmp Clean Workshop: cleanliness levels should be divided into cosmetic production areas. Production links that may be contaminated by microorganisms in content manufacturing, filling content, etc., should be located in a clean area with a higher level of cleanliness (class 100,000 to 300,000 clean area). The air in the clean area must be purified and filtered. And it is necessary to maintain a certain pressure difference, the pressure difference between different levels of clean areas should not be less than 49Pa. The pressure difference with the outdoor should not be less than 9.8Pa. There should be a buffer room between the clean area and the non-clean area, and the operator must go through dressing and air shower to enter the clean area. The clean area covers the filling room, washing room, storage room, clean packaging material storage room, static room, buffer room, clean corridor and other functional rooms, and other non-clean areas are implemented in accordance with GMP specifications.
3. Regarding the temperature and humidity of the Cosmetics Gmp Clean Workshop: the standard temperature of the laboratory is 20℃, the temperature in the general testing room and the experiment room should be 20±5℃, and the relative humidity should be maintained at 50-70%.
4. Regarding the decoration materials for the Cosmetics Gmp Clean Workshop: the laboratory floor is made of non-permeable, non-absorbent, non-toxic materials, and the surface is flat, wear-resistant and non-slip. Use light-colored, non-toxic, heat-resistant, moisture-proof and mildew-proof paint on the wall surface. The surface is smooth and dust-free, which is convenient for cleaning and disinfection.
In fact, a compliant cosmetics company needs to complete a series of feasibility analysis and perform a series of testing actions to launch any new product. Especially for formulators, the development of new formulas or the improvement of original formulas requires multi-dimensional analysis and testing of raw materials. For laboratory construction units such as Kwang Cleanroom, only if the laboratory/testing room standards and compliance are completed in a forward-looking manner, can they provide a good working environment for the cosmetics practitioners and produce more "safety" for the society. , Stable and reliable" products.
Kwang Cleanroom is proud to offer examples of a variety of our cleanroom projects below. Aseptic Purification Cleanroom Of Food Factory, Electronic Dust Free Cleanroom, GMP Cleanroom For Medical Devices, Dust Free Cleanroom Of Printing Industry, Blow Molding Film Purification Cleanroom, Aseptic inoculation Cleanroom For Edible Bacteria, Purification Projects In Other Industries.