Verification of use in clean room workshops

Verification of use in clean room workshops

The design and construction of the clean room are perfect. If the maintenance management and use are improper, it will still not work as it should, and it will be impossible to produce qualified products and protect the objects to be operated; when using sterile preparation rooms , the amount of dust brought into the sterile room should be minimized, and...

Text Labels: Cleanroom Workshop, Use Maintenance Verification

Use verification in clean room workshop

The design and construction of the clean room are perfect. If the maintenance management and use are improper, it will still not work as it should, and it will be impossible to produce qualified products and protect the objects to be operated; when using sterile preparation rooms , the amount of dust brought into the sterile room should be minimized, the number of operators in the sterile room should be controlled, and the entry of other personnel other than the operators should be strictly restricted; personnel entering the sterile room should wear professional work clothes, and their hands should be disinfected , Before entering the sterile room from the dressing room, it should be showered with air, and the items entering the sterile room should be processed through a special channel or facility before entering; the two doors of the transfer window should be interlocked. Window or sterilization transfer window; pollution control of sterile preparation room, the clean air filtered by high-efficiency filter dilutes or flattens the indoor air to maintain the required cleanliness, and adjusts the supply air volume, return air volume and exhaust air volume. It is best to set up a duty fan in the sterile room to start the duty operation program during non-working hours; the sterile room can also use ultraviolet germicidal lamps or ozone-assisted sterilization measures Sterilize its walls and system.

The non-sterile biological clean room has lower requirements than the sterile room in terms of use and management. Before the raw materials and auxiliary materials enter the clean room, the outer packaging needs to be cleaned in the preparation room, and the outer packaging should be removed, and sent to the transfer room or transfer Inside the window, enter the raw and auxiliary material preparation room in the clean area; after changing shoes, the staff take off their coats in the first shift, wash their hands in the second shift, put on clean work clothes, wash their hands again, and enter the work area from the buffer room; the clean room can Ultraviolet sterilization lamps or ozone are used for disinfection and sterilization, and the siding and equipment surfaces should be regularly scrubbed with alcohol solution; when using this type of clean room, attention should be paid to the daily clean-up work, especially the clean-up before the production of different varieties, which should be cleaned from the clean room. Thoroughly clean the walls, floors, and inside and outside of the equipment to prevent cross-contamination. The detection of dust particle count, planktonic bacteria or settled bacteria should be carried out regularly according to GMP requirements. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and clean rooms.

The difference between a biological clean room and an industrial clean clean room modular is that the biological clean room not only relies on the method of air filtration to strictly control the number of biological or non-biological particles sent into the indoor air, but also controls the indoor appliances. Disinfection and sterilization of surfaces such as floors, walls, etc.; internal materials must also be able to withstand the erosion of various sterilants. The air filtered by the high-efficiency filter can be regarded as sterile air, but filtration is only a means of sterilization. ; Due to the existence of pollution sources such as personnel and materials in the room, as long as there are nutrient sources required by microorganisms in the clean room, under suitable temperature and humidity conditions, microorganisms will survive and multiply in large numbers. Therefore, the operation and management of biological clean rooms cannot be ignored. Bacteria treatment. The cleaning of indoor equipment, utensils, transfer windows and changing rooms in the sterile room is best done with water. The walls and surfaces should be disinfected regularly. The disinfectant used should be replaced regularly. Ultraviolet rays or ozone can also be used for disinfection. Typical sites should increase the number of sterilizations. For non-sterile preparation clean rooms, the walls, ceilings and outer surfaces of the equipment can be wiped with non-fibrous rags, the floors can be wiped with semi-dry mops, and can be sterilized with ultraviolet lamps or ozone. wall.

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