Class III medical device clean room grade and temperature and humidity requirements for medical device clean room

What grade is suitable for the clean area of ​​the three types of medical pharma machinery workshops? And the temperature and humidity requirements of the medical pharma machinery clean workshop? Class I and three types of medical equipment clean workshop levels First, let's understand what the three types of medical equipment contain. Class III medical devices refer to medical devices with relatively high risks that require special measures to be strictly controlled and managed to ensure their safety and effectiveness. Implanted in the human body to support and maintain life; medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled. Such as: disposable sterile medical devices, orthopedic implant medical devices, implantable medical devices, corneal plastic mirrors, infant incubators, hollow fiber dialyzers, etc. As can be imagined from the contents of the three types of medical devices, the cleanliness requirements of the three types of medical device workshops must be relatively high. How much cleanliness does the clean area of ​​the three types of medical devices need to achieve? According to the relevant GMP regulations, Medical devices implanted and inserted into blood vessels should be carried out in a clean workshop of no less than 10,000 grades. For example: vascular stents, artificial blood vessels, venous catheters, intravascular catheters, etc. For processing with requirements or aseptic operation technology, production should be carried out in local 100 and clean workshops under the 10,000-level. For example, the compression and application of vascular stents, the anticoagulant in the production of blood bags, and the canning of maintenance solutions. .Medical devices implanted into human tissue and in direct or indirect contact with blood, bone cavity or unnatural cavities should be carried out in a clean workshop of no less than 100,000 grades. For example: pacemaker, blood filter, venous needle, artificial bone, etc. Therefore, if Class III medical devices are to be produced, the clean workshop should be at least Class 10,000 or Class 100,000, which mainly depends on the characteristics of the product. Second, the temperature and humidity requirements of the clean workshop of medical equipment The control of temperature and humidity in the clean pharmaceutical cleanroom depends on its production process. Under the conditions of satisfying the processing technology, the comfort of people should also be considered. Because people sweat, it will pollute the products, especially the semiconductor workshops that are afraid of sodium, such workshops should not exceed 25 degrees. Too much humidity creates more problems. When the relative humidity exceeds 55%, condensation will form on the wall of the cooling water pipe. If it occurs in precision devices or circuits, it will cause various accidents. When the relative humidity is 50%, it is easy to rust. So, what about the temperature and humidity requirements of the medical device clean room? In the absence of special requirements, the temperature and humidity requirements of the medical device clean room: the temperature of the 10,000-level clean room (area) should be 20 ℃ ~ 24 ℃, and the relative humidity should be 45% ~65% can meet production demand.
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