Sterile medical equipment is any medical equipment marked "sterile". The construction of dust-free workshop is the basic condition to ensure the quality of sterile medical equipment, control the environment of the production process of sterile medical equipment and standardize its production, prevent the environment from polluting sterile medical equipment. In the construction of medical equipment dust-free workshop, drug production workshop, medical biology laboratory, pharmaceutical purification workshop, operating room, etc., in order to meet the requirements of customers, will strictly refer to the following seven construction requirements:
I. Requirements for the construction and location of dust-free workshop
1. The natural environment and health conditions around the site are good, at least there is no air or water pollution source, and it is advisable to stay away from traffic arteries, freight yard, etc.
2. The ground and roads of the plant should be smooth and dust-free.It is advisable to reduce the open area by greening and other measures to control dust.Garbage, idle items should not be stored in the open air, in short, the environment of the plant should not be polluted by the production of sterile medical equipment.
3. It shall not have adverse effects on the production area of sterile medical equipment, especially the clean area.
II. Requirements for the construction and layout of dust-free workshop
In accordance with the YY0033-2000 "Standards for the Production Management of Sterile Medical Devices" Appendix B, the cleanliness level of the production environment of sterile medical equipment is set according to the guideline for setting the cleanliness level.The following aspects should be paid attention to in the design of dust-free workshop: 1, the per capita area of clean room should be no less than 4 m2 (except corridors, equipment and other items), to ensure a safe operation area.
2, according to the layout of the production process.The flow of people and logistics is reasonable.Must be equipped with personnel purification room (coat storage room, bathroom wear clean overalls room and buffer room), material purification room (stripper room, buffer room and double-layer transfer window), in addition to the use of the room required by the product process, it should also be equipped with sanitary ware room, laundry room, temporary storage room, station cleaning room, etc., each room is independent of each other, and the area of the clean workshop should be compatible with the production scale on 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 in the direction of the flow of people, from low to high;the workshop is from inside to outside, from high to low. Three, the requirements of dust-free workshop temperature and humidity
1, compatible with the requirements of the production process.
2, when the production process has no special requirements, the temperature of the air cleanliness of the million and 100,000 clean room (area) should be 20 °C ~ 24 °C, and the relative humidity should be 45% ~ 65%;the temperature of the air cleanliness of the 100,000 and 300,000 clean room (area) should be 18 °C ~ 26 °C, and the relative humidity should be 45% ~ 65%.When there are should be 18 °C ~ 26 °C, and the relative humidity should be 45% ~ 65%.When there are special requirements, it should be determined according to the process requirements. 3. The temperature of the personnel purification room should be 16 °C ~ 20 °C in winter and 26 °C ~ 30 °C in summer.
Four, requirements for aseptic detection room
The dust-free workshop must be equipped with an independent aseptic detection room with air conditioning system (separated from the production area), which is required to be locally 100 level under the condition of 10000 level. The aseptic detection room should include: personnel purification room (coat storage room, bathroom, clean work clothes room and buffer room), material purification room (buffer room or double-layer transfer window), aseptic inspection room, positive control room.
Five, product catalog for medical device dust-free workshop production
Sterile medical devices or single packaging accessories that are implanted and intervened into the blood vessel and need to be subsequently processed (such as filling and sealing) in the local 100 level clean area under 10000 level, the processing of their (uncleaned) parts, the final cleaning, assembly, initial packaging and sealing production area should not be less than 10000 level cleanliness.
Six, environmental testing report of third-party testing agencies
Provide environmental testing report of qualified third-party testing agencies within one year. The testing report must be accompanied by a floor plan, indicating the area of each room.
A. The detection items are temporarily six: temperature, humidity, pressure difference, air change times, dust number and sedimentation bacteria.
B. The detection parts are: 1. Production workshop: personnel purification room; material purification room; buffer zone; room required by product process; Station cleaning room, sanitary room, laundry room, temporary storage room, etc.
2. Sterilization testing room.
