When the packaging or loading configuration changes significantly, biological and chemical index tests will also be carried out, and continuous quality assurance tests and product tests will be carried out on representative samples of actual sterilized products. Biological and chemical indicators are placed in the product and treated at full load. Items processed in three evaluation cycles should be isolated until the test results are negative.
Gas purging and air overflow after exposure
After the exposure phase of the process, all gases must be vented from the combustion chamber until the EO content falls below the flammable limit of the gas (3% or 30000 ppm). This is done by performing a series of post vacuuming, each of which is followed by nitrogen back filling (washing).
Process design scientists have chosen the maximum working pressure for cleaning to ensure that products that may have softened during the exposure phase of the process are not damaged. Adequate washing to reduce product residues and promote safe handling of processed products.
ethylene oxide sterilization
When considering different sterilization schemes, there are many advantages to understand the sterilization process of ethylene oxide (EO or ETO). Knowledge of this process may prevent unnecessary product testing or identify product changes that may be required before attempting to sterilize with EO. The following information, although general, is intended to provide basic information about the ethylene oxide sterilization process.
Since the early 1940s, the medical and health care industry has been using EO sterilization process to sterilize medical devices. Although it is not as well controlled as today's process, the structure of the process itself is still very similar to the early process design. These similarities can be attributed to the nature of the gas itself.
Brief discussion on the instructions and application scope of ethylene oxide sterilization
Ethylene oxide, also known as ethylene oxide, is a colorless liquid at low temperature, with aromatic ether flavor, boiling point of 10.8 ℃, olfactory threshold of 760 mg / m-1064mg / m, density of 1.52; ethylene oxide is a minimum combustion concentration of 3%. Ethylene oxide gas has strong penetration. Ethylene oxide has strong sterilizing power and wide sterilizing spectrum. It can kill all kinds of microorganisms, including bacterial spores. It is a sterilizing agent.
Conditions of use
There are many factors that affect the sterilization of ethylene oxide. Only by strictly controlling the relevant factors can the sterilization effect be achieved.
Ethylene oxide sterilization device is the key equipment of disposable sterile medical equipment manufacturing enterprises. There are special requirements for installation, operation and use management. Ethylene oxide is a broad-spectrum sterilization agent, which can kill all kinds of microorganisms, including spores, tuberculosis, bacteria, viruses, fungi, etc. at room temperature.
Our company's ethylene oxide sterilizer is the best choice for mask manufacturers. Ethylene oxide sterilizer is the most professional tool for sterilizing and disinfecting medical masks and disposable civilian masks.