Clean workshop clean area hygiene environment management regulations

The environmental sanitation of the clean area of ​​the clean pharmaceutical cleanroom is very important to the clean workshop, otherwise the significance of the clean pharmaceutical cleanroom will be lost. Basis of sanitation management standards for clean areas of clean workshops: 'GMP', the actual formulation and implementation of pharmaceutical production in enterprises, to ensure the environmental sanitation of clean areas. 1. The environmental sanitation of the clean area must meet the requirements of the environmental sanitation regulations in the non-clean area, and must also meet the following requirements: 1.1 Keep the inner surfaces of all buildings in the clean area smooth, without cracks, tight joints, without particles falling off, and able to Resistant to cleaning and disinfection, measures should be taken at the junction of walls and floors to reduce dust accumulation and facilitate cleaning. 1.2 The buffer room between the clean area and the non-clean area should be intact, and the doors on both sides of the buffer room cannot be opened at the same time. 1.3 When the door must be closed during work, try to reduce the number of opening times and control the number of people in the clean area to a minimum. 1.4 All kinds of operation activities in the clean area should be stable, accurate and light, and no actions unrelated to work should be done. 2. Unnecessary items are not allowed to be brought into the clean area. All kinds of utensils, containers, tools and others that enter the clean area must be cleaned and disinfected according to the prescribed procedures before entering. 3. The use of recessed and protruding ledges, cabinets and appliances that are not easy to clean should be minimized. 4. In addition to meeting the cleaning requirements of non-clean areas, the sanitary ware room in the clean area should also be kept ventilated and dry; sanitary ware racks, mops, rags, etc. should be dried in time to prevent mold. 5. Recording paper and pens must be cleaned and disinfected before they can be brought into the clean area. The paper and pens used do not produce dust, and pencils, erasers, and pens cannot be used, but ballpoint pens are used. There are no note boards in the clean area. 6. The waste in the production process should be put into a clean container and sealed in a timely manner, placed in a designated place, and removed from the clean area in time after the work is completed according to regulations. 7. Clean and disinfect pharma machinery surfaces, containers, pipes, environments and others in the clean area in a timely manner according to regulations. 8. The cleaning agent and disinfectant used in the clean area shall not pollute the pharma machinery, materials or finished products; the disinfectant method should be ozone, ultraviolet lamp irradiation or a certain concentration of disinfectant; disinfectants should be used alternately to prevent the production of drug-resistant strains . 9. Air conditioners in clean areas must not be interrupted during production, maintain positive indoor pressure, and prevent indoor condensation. 10. The clean room shall not be arranged in three shifts, and there must be enough time for cleaning and disinfection every day. When changing batches or varieties, ensure that there is enough time for intermittent clearance, cleaning and disinfection. 11. Environmental control standards for clean areas 11.1 Cleanliness level: Class 100, Class 10000, Class 300,000 The maximum allowable number of dust particles/m3 The maximum allowable number of microorganisms ≥ 0.5µm ≥ 5µm planktonic bacteria/m3 settled bacteria/dish 100 class 3500051 10000 Class 35000020001003 Class 300000 Class 1050000060000----15 Temperature: 18°C-26°C, Relative Humidity: 45%-65% Pressure Difference: The static pressure difference between adjacent rooms with different air cleanliness levels in the clean area should be greater than 5Pa; clean The static pressure difference between the room and the outdoor atmosphere should be greater than 10Pa. 11.2 If the monitoring fails to meet the standard, corresponding measures shall be taken. 11.3 In case of humidity deviation, silica gel should be built into the air supply box to absorb moisture or other dehumidification measures should be taken. 11.4 When the pressure difference is less than or equal to 5Pa, check whether the filter is blocked, and replace or adjust the switch of the air supply outlet. If it is adjusted, all rooms should be re-tested to avoid affecting the environmental parameters of other rooms. 11.5 Settling bacteria beyond the regulations should be re-sterilized until qualified. 11.6 If the number of dust particles exceeds the standard, check whether the filter leaks or whether the air tightness of the clean room is good. 11.7 When the number of air changes is insufficient, the air intake should be increased. 12. The process pipelines and water and electricity pipelines in the clean area should be concealed to facilitate sanitation and cleaning.
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