A knowledge of the process may prevent unnecessary product testing or may identify product changes which may be required prior to attempting to sterilize with EO. Decreasing order of resistance of microorganisms to disinfection and sterilization and the level of disinfection or sterilization, Table 4. The lower the gas concentration in the chamber the longer is the sterilization time. The previous “High Temp Sterilization Method Series” discussed the most common heat sterilization methods for loads not sensitive to heat and focused on the industry's favorite method (and of course our expertise) steam sterilization and steam quality. The obvious reason is that whatever kills microorganisms is lethal to humans as well. Let us open the discussion with a warning. A lower temperature results in a less efficient process which leads to a longer exposure time. Sterigenics U.S., LLC – A Sotera Health company © 2020 All rights reserved, We use cookies to improve your site experience, assess usage of the site, and to support the marketing of our services. Clipboard, Search History, and several other advanced features are temporarily unavailable. To summarize, EtO sterilization should be used only when another method is not appropriate. These gases to supplied either cartridges (only 100%) or the Cylinders (all mixture), ✓Thank youThanks for sharing your contact infoWe will get back shortly, Sri Venkateswara Carbonic Gases Private Limited, We will contact you soon for better understanding of your product requirement & specification, Industrial,Commerical,Domestic,Laboratory. NLM eCollection 2019 Dec 17. Safety of personnel is an important issue due to the harmful effect of EtO on humans. Saving Lives, Protecting People, Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP), Introduction, Methods, Definition of Terms, A Rational Approach to Disinfection and Sterilization, Factors Affecting the Efficacy of  Disinfection and Sterilization, Regulatory Framework for Disinfectants and Sterilants, Low-Temperature Sterilization Technologies, Microbicidal Activity of Low-Temperature Sterilization Technologies, Effect of Cleaning on Sterilization Efficacy, Recommendations for Disinfection and Sterilization in Healthcare Facilities, Table 1. Sterility occurs when an EO gas molecule reacts with and destroys the microbial DNA. This gas, mixed with air at a ratio of at least 3% EtO gas, forms an explosive mixture. All products must be placed in breathable packaging that allows gas to penetrate the sterile barrier and reach all surfaces of the device or product. First, products need to go through a pre conditioning phase to make micro organisms grow. As the overall duration of this cycle is around 60 hours, high availability of the system is vital and system redundancy is required. language, region) and enable enhanced functionalities. EO is considered the sterilization method with the broadest application available for medical products and medical devices due to its effectiveness at lower temperatures and its general compatibility with a diversity of materials, resins, and product types, including: The EO process delivers a wide variety of sterilization benefits including: At Sterigenics®, our priorities are clear. The chamber is heated by either steam or hot water which is present in the jacket. This site needs JavaScript to work properly. It is a colorless, poisonous gas that attacks the cellular proteins and nucleic acids of microorganisms. Minimum cycle times for steam sterilization cycles, Table 8. Ambient room aeration also will achieve desorption of the toxic ETO but requires 7 days at 20°C. With that in mind, in addition to the facility equipment enhancements we are currently implementing across all North American EO facilities, in Q1 2020 Sterigenics and our sister company Nelson Labs®, launched a multi-year initiative to work with our customers to significantly reduce the concentration of EO in their cycles. Please enable it to take advantage of the complete set of features! The EtO enters the chamber via evaporation with a certain amount of steam to keep the humidity level up as well as to make sure the EtO is reaching all parts of the load. Ethylene oxide gas is an agent in the sterilization of medical devices due to its effectiveness and compatibility with most materials. Next, some steam is injected into the chamber and humidifies the load, since EtO is only effective in a humid environment. Model: LI-EO 4. You may accept them all or set preferences. ISO 11135, Sterilization of health care products – Ethylene oxide – Requirements for development, validation, and routine control of a sterilization process for medical devices. The excellent microbicidal activity of ETO has been demonstrated in several studies 469, 721, 722, 856, 878, 879 and summarized in published reports.877 ETO inactivates all microorganisms although bacterial spores (especially B. atrophaeus) are more resistant than other microorganisms. There are many advantages to understanding an ethylene oxide (EO or EtO) sterilization process when considering the different sterilization options. Ethylene Oxide (EtO) sterilization is mainly used to sterilize medical and pharmaceutical products that cannot support conventional high temperature steam sterilization – such as devices that incorporate electronic components, plastic packaging or plastic containers. The 100% ETO sterilizers using unit-dose cartridges eliminate the need for external tanks. eCollection 2018. EO sterilization effectiveness depends on its ability to freely diffuse through a product and packaging. As mentioned, materials such as plastics and rubbers absorb gas and if applied to patients, the toxic gas could damage their body tissue! Once the cycle is started, easy to use displays are required to show: Control of vacuum and pressure is also required. There are some advantages however. A leakage test is performed, to ensure that staff and environment are safe. The ETO-carbon dioxide (CO2) mixture consists of 8.5% ETO and 91.5% CO2. ETO should be considered a known human carcinogen.871, The basic ETO sterilization cycle consists of five stages (i.e., preconditioning and humidification, gas introduction, exposure, evacuation, and air washes) and takes approximately 2 1/2 hrs excluding aeration time. Factors affecting the efficacy of sterilization, Table 11. The data we derive helps us understand what visitors like most and improve the website. Preconditioning prepares the chamber environment to meet the ideal conditions for temperature, pressure and humidity. We should always consider that we need to do an in depth risk analysis to see if using a poisonous gas is unavoidable. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error, J-STAGE, Japan Science and Technology Information Aggregator, Electronic. It is of major importance to ensure the appropriate concentration level of EtO in the chamber to achieve effective and safe sterilization. For each batch the operator selects appropriate product recipe. Also the mixture of CO2 with Ethylene oxide is also available which the ratio of gases can be mixture is as 10:90%, 20:80%, 30:70% and vice versa. Most modern ETO sterilizers combine sterilization and aeration in the same chamber as a continuous process. To achieve this EtO is sometimes added to the chamber after a while. When in Latin America, Mario lectures about sterilization and infection control in Universities, Congresses and different events. Customization cookies allow you to configure our website to your preferences (e.g. With this “auto batch” release facility operators do not have to wait until the end of the cycle and spend time going through the batch report to understand why it went wrong. Materials (Basel). Generally sterilization with ethylene oxide in the pharmaceutical industry has been restricted given the risk it entails due to its high mutagenic and carcinogenic properties. Mechanical aeration for 8 to 12 hours at 50 to 60°C allows desorption of the toxic ETO residual contained in exposed absorbent materials. Based on a gas diffusion process, Ethylene Oxide (EO or ETO) is capable of sterilizing and rendering products free of viable microorganisms. Please use the language dropdown above to change your selection if required. For this reason B. atrophaeus is the recommended biological indicator. Comparison of the characteristics of selected chemicals used as high-level disinfectants or chemical sterilants, Table 5. Our website uses cookies delivered by us and by third parties. A number of investigations have shown that it will react with food constituents and disturb the nutritional value of … Some cookies are necessary for the website’s operation, while others can be adjusted by you at any time, in particular those which enable us to understand the performance of our website, provide you with social media features, and deliver a better experience with relevant content and advertising. After recipe has been downloaded, the operator is given the opportunity to check if values are correct for this particular batch before starting the cycle. All the key set points and tolerances as loaded by the recipe, All the key process values for the auto batch release facility, Cycle start delay to enable the system to start in stable conditions, Sterilization dwell time period under EtO. Ethylene Oxide Sterilization . For this reason it is very important to have an excessive aeration stage to remove any remaining EtO gas and to allow absorbed gas to evaporate again from the sterilized items. Mario Finkiel, is Tuttnauer's manager of Latin America and the Caribbean, originally from Buenos Aires. Ask our expert. For this reason, following sterilization the item must undergo aeration to remove residual ETO. The main disadvantages associated with ETO are the lengthy cycle time, the cost, and its potential hazards to patients and staff; the main advantage is that it can sterilize heat- or moisture-sensitive medical equipment without deleterious effects on the material used in the medical devices (Table 6).

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