principle, the design and installation of cosmetics should be set up in
principle, between the production of raw materials, between the
production of semi-finished products, filling room, packaging room,
container cleaning, disinfection, drying, storage, warehouses,
laboratories, dressing rooms, buffer Etc., to prevent cross-contamination. Cosmetics
production process to produce dust or the use of harmful, flammable,
explosive raw materials must use a separate production workshop. Production,
filling, packaging, the total area of not less than 100 square
meters, per capita area of not less than 4 square meters, the workshop
height shall not be less than 2.5 meters. Clean
room production workshop ground should be smooth, wear-resistant,
non-slip, non-toxic, non-seepage, easy to clean and disinfect。 Need to clean the work area should have a slope of the ground, no water, at the lowest place to set a clean floor drain.
The use of air purification plant production workshop, the inlet should be away from the exhaust, the entrance from the ground height of not less than 2 meters, near the source of pollution。 UV disinfection, UV disinfection lamp strength shall not be less than 70 microwatts / square centimeter, and in accordance with 30 watts / 10 square meters set, 2,0 m off the ground lifting。 Purification room production workshop The total number of bacteria in the air should not exceed 1000 / cubic meter. Bacteria in the manufacture of cosmetics, standing, filling, packaging and other parts of the product can easily cause secondary pollution. According to the new "Cosmetics Production Enterprise Health Code" requirement: the total number of bacteria in the production workshop air should not exceed 1000 / cubic meters, at the same time, semi-finished products storage, filling, cleaning container storage, dressing room and its buffer must have air purification Or air disinfection facilities.
First, Cosmetics clean room and facilities requirements:
1, whether the production environment is clean, factory floor, road
and transportation, etc. are caused by pollution of cosmetics
2, whether the production area away from pollution sources. Production of the necessary power, "three wastes" treatment and other ancillary facilities to the production environment pollution.
3, whether the plant according to the production process and the requirements of the air cleanliness level settings function, and a reasonable layout.
4, raw material pretreatment, weighing, preparation, packaging materials and containers of cleaning and disinfection, semi-finished product storage, packaging, packaging and other processes are set separately.
5, the production process is easy to produce dust or the use of harmful, flammable and explosive raw materials, whether the use of a separate production workshop and dedicated production equipment, with the appropriate health and safety measures.
6, whether there is a facility to prevent insects and other animals from entering the facility.
7, the production area is smooth ground, wear, anti-skid, non-toxic, no water, no water, easy to clean and disinfect.
8, the workshop walls and the roof is easy to clean and disinfection. Is there a suitable height of the waterproof layer.
9, whether the production area has good ventilation facilities and disinfection facilities。 Whether the new wind into the production area has been filtered。
Second, into the clean room (area) of the air is purified:
1, into the clean area of personnel and materials were buffered into or into the clean room (area).
2, in addition to the Ministry of Health cosmetics inspection requirements without microbial project inspection of the product categories and other special circumstances, the production of cosmetics production, semi-finished product storage, packaging, forming, within the packaging materials and cleaning equipment, the last fine washing, storage In the clean (area) carried out.
3, clean room (area) whether the temperature and relative humidity and cosmetic production process requirements to adapt, no special requirements, the temperature is controlled at 18-26 ℃, relative humidity is controlled at 45% -65%.
4, clean room (area) of the windows, roof and into the indoor pipes, tuyere, lamps and walls or ceiling connection parts are sealed.
5, clean room (area) of the inner surface is smooth, no cracks, tight interface, no particles off, resistant to cleaning and disinfection.
6, clean room (area) of the wall and the ground at the junction of the arc or take other measures to facilitate cleaning.
7, whether the use of the production area without shedding, easy to clean, easy to disinfect the health tools, the storage location of the material, semi-finished products, finished products caused by pollution and limited use of the region.
8, whether the production area and the scale of production to adapt to the area and space.
9, whether the setting of the locker room, lounge, bathroom and toilet has a negative impact on the production area.
10, whether the storage area with the scale of production and the area and space.
11, the workshop storage area materials, semi-finished products, pending the storage of finished products to prevent errors and cross-contamination measures.
12, the production area of various pipes, lamps, tuyere and other public facilities are easy to clean.
13, the production area of the illumination and production requirements are compatible with the plant whether there are emergency lighting facilities. Clean room (area) whether the illumination reached 300 lux.
14, air purification systems and production areas of the ventilation system is required to clean, repair, maintenance and record.
15, clean room (area) of the windows, roof and into the indoor pipes, tuyere, lamps and walls or ceiling connection parts are sealed.
16, cosmetics production is easy to produce steam in the operating area is a good dehumidification, exhaust, cooling and other facilities.
17, the production area of the pool, floor drain is the product of pollution. Production area of personnel and materials access, whether to set up a dedicated channel.
18, whether there is a buffer between the clean zone and the general production area.
19, easy to produce dust production operations such as crushing, mixing, screening, etc. are equipped with effective dust, exhaust facilities. Direct contact with the product of dry air, compressed air and inert gas is processed, in line with production requirements.
20, the storage area is installed lighting and ventilation, rodent control, pest control and other facilities, whether to set the temperature, humidity monitoring facilities.
21, whether the weighing room or the preparation room is compatible with the production requirements, if necessary, whether or not to set up the dust collection facilities, whether the inspection room or the observation room is separated from the production area, and whether the microbiological laboratory is set up separately and whether there is an ultra clean table.
Whether there are special requirements of the equipment is placed in a special instrument room, whether there is to prevent static electricity, vibration, humidity or other external factors affect the facilities。
Third, the cosmetics factory health management requirements:
whether the company has to prevent pollution of health measures and the
health management system, whether by the person responsible for health
management。 Is the production and air cleanliness level requirements to
develop container cleaning procedures, whether the contents include:
cleaning methods, procedures, , The cleaning agent or disinfectant used, the cleaning method and the storage location of the cleaning tool.
2, whether the production area of non-production products. After the completion of each stage of production, whether the waste in a timely manner.
3, the production area is regularly disinfected disinfectant whether the equipment, materials and products pollution.
4, clean room air is regularly monitored, air monitoring results are recorded archive.
5, clean work clothes selection and production operations and air cleanliness level requirements are consistent, and shall not be mixed. Clean the overalls of the texture is smooth, does not produce static electricity, do not fall off the fiber and particles. Clean overalls and general production area uniforms are cleaned , Whether it is necessary to disinfect or sterilize if necessary.
6, whether the production area is limited to the production operators in the region and approved personnel to enter, whether the temporary foreign personnel to guide and supervise the entry into the clean room (area) whether the procedures to enter, whether makeup and wearing ornaments, whether naked Whether the manufacturer has a health record, direct contact with the semi-finished product, whether the production staff is at least once a year, and whether the wounded, the skin patient and the body surface are wounded are engaged in direct contact with the product.