What are the sterilization methods commonly used in medical devices?
5, low-temperature plasma sterilization:
Low temperature plasma sterilization is a new low temperature sterilization technique developed in recent years. Plasma is the gas or steam by the electric field or magnetic field effects, so that most of the molecules formed by ionization. Plasma sterilizer is composed of power, excitation, gas, transmission system and sterilization chamber, after the vacuum through the steam, steam in the electric field under the role of change into the plasma. The advantages of plasma sterilization is the sterilization effect is reliable, the role of low temperature, sterilization equipment does not need to be placed in the air to remove residual gas, no corrosion with the same. At present, many countries have begun to use this technology, mainly for heat-resistant medical equipment.
Summary:
The validation of the sterilization process is a necessary condition for aseptic assurance that the sterility of the sterilized product depends on the choice of the sterilization material, the appropriate sterilization process in the production process, the standardized GMP management quality management system, and the sterilization process Should be considered in conjunction with bioburden testing, environmental monitoring, sterilization procedures validation and sterility testing. It is important to emphasize that the sterility test does not guarantee the sterility of each batch of product, but it is the last inspection procedure before the product is manufactured. Adherence to the sterility check helps to improve the confidence of the sterilization process and the sterile operation The
