Principles of setting up clean area for medical parts processing
- In the processing and production of sterile medical parts, production techniques that minimize pollution should be used to ensure that medical devices are not polluted or can effectively eliminate pollution.
- Sterile medical devices that are implanted and intervened into blood vessels and need to be processed (such as filling and sealing) in a local 100-level clean area under the level of 10,000 or single-packaged accessories from the factory, which (not cleaned) is zero Processing of components; final cleaning, assembly, initial packaging and sealing and other production areas should not be less than 10,000 cleanliness level.
- Reactive bridge therapy devices or single-package factory parts that are implanted into human tissues, directly or indirectly lining blood or unnatural cavities, and their (not cleaned) parts processing, final cleaning, assembly, and initial packaging The production area such as its sealing should not be less than 100,000 cleanliness level.
- The processing, final cleaning, assembly, initial packaging and sealing of sterile medical devices or single-packaged (non-cleaned) parts that are in contact with human operating surfaces and mucous membranes should be in a clean room not less than 300,000 get on.
- The use surface of sterile medical devices is in direct contact with the initial packaging materials that are used without cleaning, and the cleanliness level of the production environment should be set according to the principle of the same cleanliness level as the production environment of the product, so that the quality of the initial packaging materials meets As for the requirements of packaged sterile medical devices, if the original packaging materials do not directly contact the surface of the sterile medical devices, they should be produced in a clean room of no less than 300,000.
- Aseptic medical devices (including medical materials) that have requirements or are processed by aseptic operation technology should be produced in a local Class 100 clean room under Class 10,000.
- Clean work clothes cleaning, drying and wearing clean work clothes room, the air cleanliness level of the final cleaning and disinfection area of the special work station equipment can be lower than the production area, the finishing of sterile work clothes, and the storage after the bacteria Requires a class 10,000 clean area.
The dirt of mechanical parts is mainly composed of grease, anti-rust grease and other mixtures of sludge. It can be cleaned with alkaline cleaning fluid, electrochemical cleaning, or ultrasonic cleaning machine. Ultrasonic cleaning machine cleaning is a special category of cleaning. , Belongs to industrial cleaning.
Clean with alkaline cleaning fluid
The process flow of alkaline cleaning liquid chemical cleaning is: mounting-lye cleaning-water washing (50-900C hot water)-drying (clean hot compressed air drying, strict parts and components, after being dried by compressed air, It also needs to be baked for 10 minutes in an electric blast drying oven at 105-1150C.
Electrochemical cleaning with alkaline cleaning solution
The electrochemical cleaning of alkaline solution should pay attention to the following points: It is not suitable to clean the thick oil on the surface of the machine. When the oil is thick, other methods should be used for pre-cleaning; generally steel parts should be cleaned on the cathode and then on the anode. Spring parts, thin-walled steel parts, ultra-high-strength steel parts, etc. cannot be cleaned on the cathode (to avoid hydrogen permeation of the material and hydrogen embrittlement); parts made of copper, zinc, nickel and other materials cannot be cleaned on the anode (avoid Surface oxidation of materials); quantitative analysis of electrolyte is carried out regularly.
