What is the production environment purification standard of disposable sterile drainage bag kit - standard edition?
Publish Time: 2024-12-04
As a medical device, the production environment of disposable sterile drainage bag kit-standard edition has strict purification standards.First of all, the overall environment of the production workshop is usually required to reach a cleanliness level of not less than 300,000. In such an environment, the number of dust particles in the air is strictly controlled, which can effectively reduce the adhesion of microorganisms and impurities, thereby reducing the risk of product contamination.For the processing areas of parts, such as the cutting of drainage bags and the production of connecting tubes, if these parts are not cleaned and directly used for assembly, then the processing environment should be not less than 100,000 cleanliness level. This helps to ensure that the parts remain relatively clean before entering the assembly process, laying the foundation for the subsequent production of sterile products.In key production areas such as final cleaning, assembly, primary packaging and sealing, the cleanliness requirements are higher, generally not less than 10,000. In the 10,000-level clean area, the air is filtered efficiently, and the number of dust particles greater than or equal to 0.5 microns per cubic meter of air shall not exceed 352,000, the number of floating bacteria per cubic meter shall not exceed 100, and the number of settled bacteria per culture dish shall not exceed 3. Such strict standards can ensure that the product is not contaminated by the outside world during the assembly and packaging process to the greatest extent, ensuring aseptic performance.In addition, the temperature and humidity of the production environment also need to be strictly controlled. The general temperature should be maintained at 18℃-28℃, and the relative humidity should be 45%-65%. Appropriate temperature and humidity are not only conducive to the working comfort of operators and the normal operation of production equipment, but more importantly, they can prevent problems such as material deformation and microbial growth caused by inappropriate temperature and humidity, thereby ensuring product quality.At the same time, the production workshop also needs to be disinfected and tested regularly to ensure that the sterility of the environment always meets the standards. Disinfection can be achieved by combining ultraviolet irradiation, chemical disinfectant wiping and other methods. Testing includes regular monitoring of multiple indicators such as airborne planktonic bacteria, settling bacteria, and dust particle count, so as to promptly discover and resolve possible environmental problems and ensure that the production environment of the disposable sterile drainage bag kit-standard edition is always in a good purification state.
