Ethylene oxide eto sterilization is a chemical process consisting of. During this process, eto acts as an alkylating agent, effectively disrupting the dna of microorganisms to prevent them from reproducing, ultimately resulting in sterile products suitable for medical use. Eto sterilizer is equipment, which facilitate eto sterilization process. Eto has no effect on the item being sterilized, so designers are not restricted in the plastics they can use, as they are when sterilizing with gamma irradiation. Eto sterilization validation apppplicable standards ansiaamiiso 1151. Introduction to eto sterilization linkedin slideshare. Medical devices ethylene oxide gas sterilization process design process validation. During this process, eto acts as an alkylating agent. Qualification of ethylene oxide and gamma sterilisation. One of the disadvantages of gas plasma sterilization is that it may not penetrate narrow. Sterilization providers that do not have an approved fixed chamber eto sterilization process for the device in an existing pma. Introduction of eto sterilizer and sterilization process.
Not everything in the hospital can, or should be sterile. Sterilization validation, qualification requirements dawn tavalsky 2 sterilization overview objectives discuss definition of sterile briefly describe sterilization methods describe approaches to be. There are many advantages to understanding an ethylene oxide eo or eto sterilization process when considering the different sterilization options. Filtration sterilization by filtration is employed mainly for thermolabile solutions. This complex process and subsequent monitoring takes longer than radiation. Feb 11, 2016 this feature is not available right now. Eto does have some disadvantages, including a relatively long sterilization. Iso 115 eto sterilization for medical devices one of the most popular methods of sterilization of medical devices is through exposure to ethylene oxide gas eto eo. Requirements for the development, validation and routine control of a sterilization process for medicalroutine control of a sterilization process for medical devices ansiaamiiso 1152. Ethylene oxide sterilization based on a gas diffusion process, ethylene oxide eo or eto is capable of sterilizing and rendering products free of viable microorganisms. The gas is an alkaline agent that infiltrates packaged medical devices to kill microorganisms and thus achieve sterilization.
Center for devices and radiological health ethylene oxide. Sterilization is considered a processing step within the overall healthcare product manufacturing process. Decontamination is the process of removal of contaminating pathogenic microorganisms from the. Changes in contract sterilization providers or addition of a new. Aug, 2015 eto stands for ethylene oxide sterilization ethylene oxide sterilization is a type of chemical process consisting of four primary variables namely gas concentration, humidity, temperature and time. The variables and their relevance on process optimization are described, the types of processing cycles are detailed and emphasis is given to the. These eto models minimize potential eto exposure during door opening and load transfer to the aerator. Eto does have some disadvantages, including a relatively long sterilization cycle and the need for aeration for a specified amount of time, after sterilization. Anatomy of an ethylene oxide sterilization process techtip. The sterilization modality selected for a product is based on a number of factors, including material compatibility, process availability, processing location, physical device attributes, legacy regulatory. Ethylene oxide sterilization uses a 3part gas process which includes pre conditioning, sterilization, and aeration.
Eto is toxic and porous materials exposed to eto will absorb the toxic gas requiring aeration following the sterilization process to allow. Ethylene oxide is an alkylation agent that disrupts dna of microorganisms, which prevents them from reproducing. Ebeam, xray and ethylene oxide technologies for the. The process involves exposing products to ethylene oxide gas under vacuum. Aug 07, 2012 this webinar is designed to acquaint those in the medical device community with the appropriate ways to develop, optimize, and validate an ethylene oxide sterilization process.
Eto gas infiltrates product as well as packages to kill microorganisms that are left during production or packaging. Qualification of ethylene oxide and gamma sterilisation processes. Materials which cannot be sterilized by heat are being used increasingly in medicine, and their sterilization at the present time is not entirely satisfactory. Eto is a colorless gas, which destroys microorganisms by a process called alkylation. Ethylene oxide also known as eo or eto processing is widely used for the sterilization of healthcare devices and instruments. Ethylene oxide eto sterilization is a chemical process consisting of four primary variables. The vacuum process needs to perform the emergency evacuation phase for a fast evacuation of gas. Ethylene oxide eto gas is one of the most common ways to sterilize medical devices, a process which is critical for preventing infections and ensuring patients have safe surgeries and medical treatments. Due to the toxic effect of eto, water ring rotary pumps are used.
Ethylene oxide eto sterilization for medical devices introduction medical device manufacturing is both demanding and complex. The training course is designed to create better understanding of the. Advancement in medical procedures has resulted in the increased usage of delicate instruments which cannot be steam sterilized. 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. This complex process and subsequent monitoring takes longer than radiation sterilization but recent technology advances have greatly reduced the cycle time for eto sterilization. Sterilization and depyrogenation are useful process in sterile pharmaceutical manufacturing and both are almost similar but have huge difference. Sterilization of endoscopes fda panel recommendation for duodenoscopes, may 2015. Ethylene oxide also known as eo or eto is a low temperature gaseous process widely used to sterilize a variety of healthcare products, such as singleuse medical devices. Validation of an ethylene oxide sterilization cycle demonstration of the effectiveness of an ethylene oxide sterilization cycle is achieved through the validation process. Recent technological advances have greatly reduced the cycle time of eog sterilization, due to the development of aeration processes optimization. Mechanical aeration for 8 to 12 hours at 50 to 60c allows desorption of the toxic eto residual contained in exposed absorbent materials. Eto is used in gas form and is usually mixed with other. Ethylene oxide eto sterilization for medical devices.
Ethylene oxide sterilization process pdf free download as pdf file. The sterilization modality selected for a product is based on a number of factors, including material. Through the use of a vacuumbased process, eo sterilization can efficiently penetrate surfaces of most medical devices and its lower temperature makes it an ideal process for a wide variety of materials. Eto sterilizer and sterilization process slideshare. Explore our resources for the technical support and software updates you need for your madgetech products. Pdf ethylene oxide sterilization validation and routine. Ethylene oxide sterilization uses a 3part gas process which includes preconditioning, sterilization, and aeration. Eto is used in gas form and is usually mixed with other substances, such as co2 or steam. Requirements for the development, validation and routine. Ethylene oxide sterilization in hospital practice ncbi. Working pressure in the sterilization room 700 mbar, humidity 60 to 70% rh, eto concentration 450 800 mgl. To understand the difference between sterilization and. However, only recently has its use significantly emerged, based on its range of applications in the field of new medical device development. A concise reference chart providing general compatibility guidelines for polymers and polymer families with major sterilization technologies.
Commissioning demonstrates that the sterilization equipment intended for. Sterilization of health care products ethylene oxide requirements for development, validation and routine control of a sterilization process for medical devices american national standard i o his is a. Ethylene oxide gas sterilization of medical devices. Sterilization is an absolute condition while disinfection is not. For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. Ethylene oxide eoeto sterilization introduction to 2. A sterilization process should be verified before it is put into use in healthcare settings. All the key process values for the auto batch release facility. It is the use of physical or chemical means to remove, inactivate, or destroy. Validation is the total process starting with commissioning, followed by performance qualification. Microbial safety in spices, a top priority sterilization and pasteurization of spices, powder, herbs and grains a variety of microbial reduction techniques are routinely employed within the industry for. Among the sterilization technologies currently available to the.
For more specific details and recommendations go to infection control websites. The sterilized contents are then aerated to remove. This webinar is designed to acquaint those in the medical device community with the appropriate ways to develop, optimize, and validate an ethylene oxide sterilization process. Microbial safety in spices, a top priority sterilization and pasteurization of spices, powder, herbs and grains a variety of microbial reduction techniques are routinely employed within the industry for reduction of pathogens. The sterilization methods covered are autoclave, dry heat, ethylene oxide gas eto, gamma irradiation and elec tron beam ebeam radiation. Decontamination is the process of removal of contaminating pathogenic microorganisms from the articles by a process of sterilization or disinfection.
Eto stands for ethylene oxide sterilization ethylene oxide sterilization is a type of chemical process consisting of four primary variables namely gas concentration, humidity. The eto penetrates the cells membrane and reacts with the nuclear material rendering it unable to metabolize and reproduce. Ethylene oxide eto or eo the future of gas sterilization. Sterility occurs when an eo gas molecule reacts with and destroys the microbial dna. Ethylene oxide eo or eto sterilization sterigenics. All steam, eto, and other lowtemperature sterilizers are tested with biological and chemical indicators. Eto residue either within the sterilizer chamber or in a separate aerator. Sterilization and depyrogenation are useful process in. Ethylene oxide sterilization is a type of chemical process consisting of four primary variables namely gas. Sterilizing units, ethylene oxide world health organization. Ethylene oxide sterilization of medical devices american hospital. Equipment sterilization disinfection 03272011 this section of the manual is intended to be an overview of disinfection and sterilization in the health care setting. Ethylene oxide sterilization takes place at 37c to 52c.
Anatomy of an ethylene oxide sterilization process. Sterilization validation, qualification requirements. Initial registration products are delivered to the bsa warehouse boxes on pallets and registered. Ethylene oxide eto sterilization process eurotherm by. Sterilization can be defined as any process that effectively kills or eliminates transmissible agents such as fungi, bacteria, viruses and prions from a surface, equipment, foods, medications, or biological.
Ethylene oxide eo is a wellknown sterilizing agent. While most prevalent in the manufacture of sterile products it can be used in a variety. Ethylene oxide sterilization for medical devices fda. The training course is designed to create better understanding of the ethylene oxide eto sterilization process for the medical device manufacturing professionals in malaysia. The process involves exposing products to ethylene oxide gas under vacuum in a sealed chamber. The bioindicator strain proposed for validation of the sterilization process is.
To understand the difference between sterilization and depyrogenation, we have to discuss both of them separately, in length to really know the line that separates them. Ethylene oxide eto sterilization process sterilize medical and pharmaceutical products 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. Each technique has advantages and limitations in effectiveness, quality. By following a structured method, process engineers can design and validate safe and efficacious eto steilization cycles. Deliberate decision making during the structuring of microbial challenges, product loads, and biological indicators can provide a validation process for eto sterilization that ensures accuracy, the absence of microbes, and a smooth testing procedure. All steam, eto, and other lowtemperature sterilizers are tested with biological and chemical indicators upon installation, when the sterilizer is relocated, redesigned, after major repair and after a sterilization failure has occurred to ensure they are functioning prior to placing them into routine use. The variables and their relevance on process optimization are described, the types of processing cycles are detailed and emphasis is given to the design and validation of the sterilization process. Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe. The sterilization methods covered are autoclave, dry heat.
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