In the dust-free workshop transformation production process to do a good job in health monitoring and management, to prevent cross-contamination, play an important role in product quality, so the quality of clean room clean room process hygiene management system.
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First, the purpose:
In the dust-free workshop transformation production process to do a good job in health monitoring and management, to prevent cross-contamination, play an important role in product quality, so the quality of clean room clean room process hygiene management system.
Second, the scope: for the flow of people in the clean room, logistics and workshop environment, the management of other elements related to clean facilities
Third, the working procedures:
1. Personnel entering the clean area must undergo a physical examination and obtain a health certificate before they can be employed. They should be reviewed once a year. If they are not qualified, they must be transferred. Workers with colds are not allowed to work in the clean area.
2. The area occupied by each person in the clean area shall not be less than 4 square meters.
3. Management of work clothes in the clean area can be found in the Management System of Work Areas in Clean Areas.
4, after the day after work, the clean room renovation should be disinfected with UV light for 60 minutes, and fill in the "UV lamp disinfection record" with formaldehyde fumigation once a month, half an hour, and fill in the "fumigation record"
5. People must flow out into the clean area in accordance with the following procedures and requirements.
People enter ------- change shoes ----- take off the coat ------ wash hands ------ wear clean clothes ------- hand disinfection ------- Wind forest
Clean area ------ go out ------ take off clean clothes - ------ wear outerwear ----- change shoes ------- people out
6. The preparation of disinfectant is carried out by a special person and disinfected with 0.3 disinfectant.
7. Logistics entering the clean area must be carried out in accordance with the following procedures and requirements:
Item-----Unpacking room-----Double-layer transfer window--Clean area-------Double-layer transfer window--Packing room
8. Parts and raw and auxiliary materials entering the clean area must be unpacked through the double-layer transfer window, and the products produced must be sealed from the transfer window after being sealed by packaging.
9. After work every day, the operator should do the work of the countertop, the ground, the stool, clean the ceiling of the wall every week, and fill in the “cleanroom record of clean roomâ€
10. No nails may be left in the clean area, nail polish shall not be applied, rings, bracelets, watches, necklaces shall not be worn, no food shall be allowed, no loud noises shall be allowed, and work clothes shall not be worn to leave the clean area or wear uniforms to enter the clean area. Masks must be worn
11. The turnover box of the clean area should be used with a non-porous cover box, and should not be used with the turnover box in the non-clean area.
12. Under the premise of ensuring the cleanliness, the turnover box should be cleaned no less than once a week to ensure its cleanliness and fill in the “Working Instrument Cleaning and Disinfection Recordâ€.
13. The tooling in the clean area is to be maintained by the operator after work every day, keeping the tooling clean.
14. Compressed air used for inspection and production in clean areas must be purified.
15. Renovation of clean room in the production process, spare parts falling on the ground must be cleaned before reuse, the product should not be mopped when assembling
16. The clean room operator must disinfect the hand with alcohol every 2 hours to prevent the sweat or skin loss from affecting the product quality.
17. When you get off work every day, you must put the product in the turnover box and cover it to prevent pollution.
18. The lighting device in the purification workshop is inspected and maintained once every two months to ensure the completeness, cleanliness and illumination of the use.
19. UV lamps should be numbered separately, and the time of their initial use should be recorded. The cumulative use time should be replaced after more than 800 hours of use. The UV intensity can also be tested once a year. If the strength is less than that, it should be replaced. The lamps should be wiped once a week with alcohol. And make a record
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