food&GMP standard for health care products clean workshop_Company News_News_sz-pharma

The design of the for food and health products involves many disciplines such as food chemistry, microbiology, physics, etc. in terms of functions, and also involves complex processes such as ventilation, exhaust, water supply, drainage, etc., and at the same time, environmental protection, Safety, sustainable development and many other factors are a very complex system engineering. The cost of GMP for food and health products varies with the requirements of cleanliness level 2, and there are almost no ISO 3 and 4 (1 and 10) devices. An ISO Class 5 (Class 100) cleanroom costs twice as much as an ISO Class 6 (Class 1000) pharma clean room. In the food and health product production workshop, only a small part of the food clean room utilizes the ISO5 (class 100) space, and the real use of the ISO5 standard is mainly in small areas such as filling production lines. Leijian Construction Engineering recommends that the design be divided according to the layout of the production line area, and then decide the decoration design requirements of the clean production workshop. 1. Main points of decoration design of GMP for food and health products 1. The GMP for food and health products can be isolated from the outside world, and cannot pass through or be interfered by other factors. 2. The size of the GMP for food and health products depends on the needs, and generally consists of a dressing room, a buffer room, an air shower room and an operation room. The dressing room is placed outside, mainly for changing clothes, hats, shoes, etc.; the buffer room is located between the dressing room and the air shower, and can also be connected with several operating rooms at the same time; the operating room is placed in the inner room, mainly for product filling, room Should not be exposed to direct sunlight, the size is appropriate, and the height is appropriate (specifically determined according to the height of the production equipment). If the room is too large, cleaning and disinfection will be inconvenient; if it is too small, it will be inconvenient to operate; if the top is too high, it will affect the effective sterilization effect of ultraviolet rays. Walls should be smooth without dead ends for cleaning and disinfection. 3. The GMP for food and health products should be closed and keep the static pressure difference of the pharmaceutical cleanroom as positive pressure, and set up ultraviolet lamps, air filter purifiers and constant temperature devices for air disinfection. 2. The building layout of the GMP for food and health products The building layout should belong to the professional category of the construction profession, but because the GMP for food and health products requires the separation of people and materials, and the static pressure gradient between each clean operation room should be maintained. Suggested layout: 1. Each purification operation room is centrally set up with an independent front room as an air lock, and the air lock room is connected with each operation room at the same time to ensure that the air in the low clean area does not penetrate into the high clean area. 2. The flow of people in the pharma machinery passes through the locker room to change clothes and shoes - + wash hands in the washing room - + buffer room - → air shower room - + each operating room. 3. The logistics of the GMP of food and health products are sterilized from the outer corridor through the mechanical chain self-disinfection transfer window, and then enter the buffer corridor, and then enter each operating room through the transfer window. 3. The internal structure of the GMP for food and health products According to the 'Clean Design Specification', the walls and hanging items of the workshop must be constructed with materials that do not produce dust and have a smooth surface, and there should be no dead corners in the pharmaceutical cleanroom. The special color plate for the construction of the purification pharmaceutical cleanroom can be used, the top plate of the base plate is made of Baosteel 0.4 steel plate, and the core material density reaches 14kg/m3, and the aluminum material adopts Hualian special aluminum profile. The profiles are electrophoresed. 4. The floor and lighting floor of the GMP for food and health products are made of solvent-based epoxy resin with a strength of above C20. The surface is dense and free of sand, hollow and cracks. Bright colors, long-lasting anti-static properties, can withstand moderate loads and high temperature resistance. On the basis of satisfying the use, it can play the role of decoration, wear-resistant, washable, dust-proof, anti-skid, excellent in performance, uniform in color and gloss. The clean area should use ceiling-type purification lamps, and the non-clean area should use ordinary fluorescent lamps. The lighting in each room is designed, and the ultraviolet lamps are independently controlled, and all are controlled by the electrical control box, and then centrally controlled by the main power distribution cabinet; the indoor lighting adopts closed lighting groups; V. The design of the ventilation and air purification pharma machinery for the GMP of food and health products. The design of the is based on the requirements of the specification, and the design-return air system. The computer room is located on the top side of the factory building (according to the actual situation, the unit type purification system can be used instead of a computer room), and each supply and return air circulation duct is connected to the air conditioning unit in the technical interlayer to form a system. The supply and return air ducts are made of galvanized steel and are softly connected by air valves. Galvanized steel ducts are made on site.

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