Difference between irradiation sterilization and ethylene oxide sterilization

Technical comparison of irradiation sterilization and ethylene oxide sterilization I. Introduction of common sterilization methods for medical devices 1. Medical devices commonly used sterilization method of introduction 1. irradiation sterilization is the use of nuclear radiation principle by using the energy of atomic energy rays caused by microbial death, so as to achieve the purpose of sterilization, with complete sterilization, non-toxic, no residue, green, low energy consumption, energy saving advantages. The commercial use of cobalt-60 γ rays and electron gas pedal generated by less than 10MeV electron beam to irradiation sterilization. 2. 2. EO steam sterilization (ethylene oxide) is a broad-spectrum, low-temperature sterilizing agent that kills a variety of microorganisms at room temperature, including bacilli, tuberculosis bacilli, bacteria, viruses, fungi, etc. ETO can alkylate with hydroxyl (-COOH), amine (-NH2), sulfhydryl, (-SH), and hydroxyl (-OH) on proteins, causing microbial proteins to lose their reactive groups and impeding normal chemical reactions and metabolism, thus preventing the microorganisms from reacting with each other. The microbial protein loses its reaction group, which prevents its normal chemical reaction and metabolism, thus leading to the death of microorganisms. 3. 3. High-temperature steam sterilization, as the name suggests, that is, the use of high temperature of water vapor to achieve the effect of disinfection and sterilization.

Items of special requirements for packaging chemical residues of significant warming

Sterilization effect (whether or not to achieve sterilization, that is, SAL = 10-6) batch processing quantities of post-processing time Irradiation sterilization No small molecules can be caused by the precipitation of No Yes Cyclic sterilization, can meet the processing of any number of Irradiation can be used immediately after the use of EO steam sterilization must be used with a special package Yes Yes Yes Yes by the disinfection box volume, generally less than 30m2, generally less than 30m2, the volume of the sterilization chamber to determine, and can be used for sterilization. EO steam sterilization Must use special packaging materials Yes Yes Yes Depends on the volume of the sterilizer, generally less than 30m3/times After processing, the product must be allowed to stand for at least 48 hours to evaporate and reduce chemical residues inside the product High-temperature steam sterilization Special packaging materials must be used No Yes No Depends on the volume of the sterilizer A certain amount of time is needed to cool down after processing II. Research (Fortune 500 and large domestic companies, extracted from the Internet) III. Status of irradiation sterilization of syringes in China Most of the syringes sold in China are sterilized by ethylene oxide, while some manufacturers use irradiation sterilization for syringes. IV. Advantages and disadvantages of using irradiation sterilization and ethylene oxide sterilization for syringes 1. Because of the use of syringes in China is used to be with a needle, but the needle tube is a metal material, is not easily penetrated by gamma rays, and therefore will affect the sterilization effect of the inner lumen of the needle tube. 2. 2. irradiation sterilization is a destructive sterilization method, the general material can not withstand irradiation sterilization (material yellowing and brittle), in order to make up for this defect, it is necessary to add more additives in the plastic to resist the effects of irradiation rays. In order to compensate for this, more additives are added to the plastic to counteract the effects of irradiation. Inevitably, the material itself will degrade to a certain extent and precipitate small molecules that can be absorbed by the drug. There is also a risk that more additives will be leached out of the drug. 3. Ethylene oxide sterilization is a gas sterilization, first vacuum and then injected into the ethylene oxide, so the ethylene oxide can penetrate into the inner cavity for sterilization. Therefore, it is not possible to say that irradiation sterilization is an absolute safety