Aseptic medical devices are any medical devices marked "sterile", the construction of a dust-free workshop is the basic condition to ensure the quality of aseptic medical devices, control the environment of the production process of aseptic medical devices and regulate its production, to prevent environmental pollution of aseptic medical devices. In the construction of medical equipment dust-free workshop, drug production workshop, medical biology laboratory, medical purification workshop, operating room, etc., in order to meet customer requirements, will strictly refer to the following seven construction requirements:
First, dust-free workshop construction site requirements
1, the natural environment and health conditions around the location are good, at least no air or water pollution sources, but also far away from traffic roads, freight yards and so on.
2. The ground and roads of the plant should be smooth and dust-free. It is advisable to reduce the area of soil exposure or to control dust through afforestation and other measures. Garbage, idle items, etc. should not be stored in the open air, etc. In short, the environment of the factory should not pollute the production of sterile medical devices.
3, shall not have an adverse effect on the production area of sterile medical devices, especially the clean area.
Second, dust-free workshop construction layout requirements
The level of cleanliness is set in accordance with the guidelines for setting the cleanliness level of sterile medical device production environment in Appendix B of YY0033-2000 "Sterile Medical Device Production Management Standards". The following aspects should be paid attention to in the design of clean workshop:
1, clean room per capita area should be not less than 4 square meters (in addition to corridors, equipment and other items), to ensure that there is a safe operating area.
2, according to the production process layout. Flow of people and logistics are reasonable. It must be equipped with personnel purification room (coat storage room, washroom wearing clean work clothes room and buffer room), material purification room (outside room, buffer room and double transfer window), in addition to equipped with the product process requirements of the outdoor room, should also be equipped with sanitary ware room, laundry room, temporary storage room, station equipment cleaning room, etc., each room is independent of each other. The area of the clean workshop should be adapted to the scale of production under the premise of ensuring the basic requirements.
3, the same clean room (area) or adjacent clean room (area) does not produce pollution.
4, according to the air cleanliness level, it can be written according to the direction of flow, from low to high; The workshop is from inside out, from high to low.
Third, the requirements of temperature and humidity of dust-free workshop
1, suitable for production process requirements.
2, when the production process has no special requirements, the air cleanliness of the clean room (area) should be 20℃ ~ 24℃, and the relative humidity should be 45% ~ 65%; The temperature of the clean room (area) of 100,000 and 300,000 levels of air cleanliness should be 18 ° C ~ 26 ° C, and the relative humidity should be 45% ~ 65%. If there are special requirements, they should be determined according to the process requirements.
3, the temperature of the personnel purification room, winter should be 16℃ ~ 20℃, summer should be 26℃ ~ 30℃.
4. Requirements for sterile test room
The dust-free workshop must be equipped with a sterile testing room (separate from the production area) of an independent purification air conditioning system, which is required to be a local hundred under 10,000 level conditions. The sterility test room shall include: personnel purification room (coat storage room, washroom, clean work suit room and buffer room), material purification room (buffer room or double-layer transfer window), sterility test room and positive control room.
5. Product catalog for medical device dust-free workshop
For sterile medical devices or single-package accessories implanted and inserted into blood vessels and requiring subsequent processing (such as filling and sealing, etc.) in local 100-level clean areas under 10,000, the processing, final cleaning, assembly, initial packaging and sealing of their (non-cleaning) parts in the production area should not be less than 10,000 level of cleanliness.
6. Environmental testing report of third-party testing institutions
Provide a qualified third-party inspection report within one year, the inspection report must be attached to the floor plan, indicating the area of each room.
