2.2 Plant and Facilities
2.2.1 There should be a neat and clean production environment. The ground of the plant, the environment around the road surface and transportation should not cause pollution of the production of products. The general layout of the administrative area, living area and auxiliary area is reasonable and shall not have any adverse effect on the production area. The factory should be far away from areas with polluted air and water and other sources of pollution.
2.2.2 Production plant should be set up to prevent dust, insects and other animals from entering the facilities. Clean room (area) doors, windows and security doors should be closed, clean room (area) door should be opened to the direction of high cleanliness.
2.2.3 In vitro diagnostic reagents should be based on the control of the production process, to determine the appropriate level of clean room (area) in the production process, to avoid contamination in the production. Air clean level of different clean room (area) between the static pressure difference should be greater than 5 Pa, clean room (area) and the outdoor atmosphere of the static pressure difference should be greater than 10 Pa, and there should be an indication of the pressure difference of the device. The same level of clean room pressure difference between the gradient should be reasonable.
2.2.4 Enzyme-linked immunosorbent assay reagents, immunofluorescence reagents, immunoluminescence reagents, polymerase chain reaction (PCR) reagents, gold-labeled reagents, dry chemistry reagents, cell culture media, calibrators and quality control products, enzymes, antigens, antibodies, and other active components of the preparation and dispensing of the product of the preparation of the liquid, encapsulation, dispensing, spotting, drying, cutting, film and internal packaging, etc.. The production area should be no less than 100,000 cleanliness level.
2.2.5 Negative or positive serum, plasmid or blood products, such as processing operations, the production area should be not less than 10,000 cleanliness level, and should be maintained with adjacent areas of relative negative pressure.
2.2.6 Aseptic materials and other processing operations, the operation area should be in line with the local cleanliness level of 100.
2.2.7 The production of general chemical reagents should be carried out in a clean environment.
2.2.8 Clean room (area) air cleanliness level should be consistent with the following table:
Table Clean room (area) air cleanliness level
Cleanliness level
Dust particles maximum permissible/m3
Microorganisms maximum permissible number of
≥0.5μm
≥5μm
Planktonic bacteria/m3
Sedimentation bacteria/dish
Class 100
3,500
0
5
l
Class 10,000
350,0O0
2,000
100
3
1OO,000
3,500,000
20,000
500
10
2.2.9 Clean room (area) should be in accordance with the in vitro diagnostic reagent production process and the required level of air cleanliness for a reasonable layout, the flow of people, the flow of goods should be reasonable. The same clean room (area) or adjacent clean room (area) between the production operation shall not cross contamination.
2.2.10 into the clean room (area) of the pipeline, air inlet and outlet layout should be reasonable, water, electricity, gas transmission lines and wall interfaces should be sealed reliably, lighting fixtures shall not be suspended.
2.2.11 clean room (area) temperature and relative humidity should be compatible with the requirements of the production process. No special requirements, the temperature should be controlled at 18 ~ 28 ℃, relative humidity control in 45% ~ 65%.
2.2.12 Clean room (zone) and non-clean room (zone) should be buffered between facilities.
2.2.13 Clean room (area) of the internal surface (walls, floors, ceilings, operating platforms, etc.) should be smooth, no cracks, interface tight, no particles off, to avoid the accumulation of dust, and easy to clean and disinfection.
2.2.14 clean room (area) air such as recycling should take effective measures to avoid contamination and cross-contamination.
2.2.15 clean room (area) in the pool, floor drain should be installed to prevent backflow of the device to avoid pollution of the environment and materials.
Class 100 clean room (area) shall not be installed in the floor drain.
2.2.16 dust production operation room should maintain a relative negative pressure or take effective measures to prevent the spread of dust to avoid cross-contamination.
2.2.17 Polluting, infectious and highly biologically active materials should be handled under controlled conditions to avoid infection, contamination or leakage.
2.2.18 The production of hormones, the operation of pathogenic pathogens or germinal bacteria products, should use a separate air purification system, and adjacent areas to maintain a negative pressure, the discharged air can not be recycled.
2.2.19 To carry out the operation of pathogens with a degree of risk of two or more should be equipped with a biological safety cabinet, the air should be filtered and treated before being discharged. The performance of the filter should be regularly checked to ensure its effectiveness. Positive serum using pathogen-based detection reagents should have appropriate protective measures.
2.2.20 For the collection and preparation of special highly pathogenic pathogens, the corresponding biosafety facilities should be equipped in accordance with industry standards promulgated by the relevant departments, such as the list of microorganisms of infectious diseases on earth, general guidelines for biosafety in microbiological and biomedical laboratories, and general requirements for laboratory biosafety, and other relevant regulations.
2.2.21 The production of polymerase chain reaction (PCR) reagents, its production and inspection should be carried out in a separate building or space to ensure that the air is not directly connected to prevent cross-contamination caused by aerosols formed during amplification. Its production and quality control instruments shall not be mixed, after use should be strictly cleaned and disinfected.
2.2.22 The number of people in the clean room (area) should be compatible with the clean room (area) area.
2.2.23 In vitro diagnostic reagents without air purification requirements for the production environment, should be in a clean environment for production.
Basic requirements for clean conditions: there should be dust, ventilation, to prevent insects or other animals and foreign objects mixed in and other measures; people and logistics are separated, the personnel should enter the production plant before changing shoes, changing clothes, wearing masks and hats, hand washing, hand disinfection and other cleaning measures; the floor of the production site should be easy to clean, the wall, the top should be flat, smooth, no particles off; operating table should be smooth, Flat, no gaps, corrosion resistance, easy to clean and disinfect; should be regularly cleaned, cleaned and disinfected production area; should be based on the production requirements of the production workshop temperature and humidity control.
2.2.24 Management of materials that are flammable, explosive, toxic, hazardous, polluting or infectious, biologically active or originating from living organisms should be in accordance with relevant national regulations. The materials involved should be listed, stored in a special area, special custody and issuance, and the development of appropriate protection procedures.
2.2.25 The animal room should be in a well-isolated building, separate from the production and quality control areas, and shall not pollute the production. (Omitted)
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