Ethylene Oxide UUXRRRUAUUA XCUUUU–U –R GGGEEU– Formaldehyde 100% BAA–U–CAA–A AACC–BBU –– CA–AA–A Formaldehyde 37% AAARRRAARRA AABXU––R –R EEUGGEG In comparison, gamma radiation has high penetration and low dose rate, while E-beam has high dose rate and low penetration, but either technology can give a reproducible irradiation process. Ethylene oxide (EO) does not readily adsorb on Tyvek® and is released more rapidly than from cellulosic materials such as medical-grade papers, including synthetic fiber-reinforced paper. Hydrogen Peroxide Gas Plasma 150 111 0000478984 00000 n For many materials used to manufacture medical device and pharmaceutical components and packaging, it is possible to select and validate an appropriate and compatible industrial sterilization technique. 0000475198 00000 n =��,"�/1P����A`I=��]7�ý�s��}�{��R>@o��}����`o�o�m���S+���-�j�����#�|��B���;���pU��]%�=3"�h�������G���eE �>|l�#��?��2h���O�*cNP��G#����%���µ�>����2=�L � q��L���.kj�?�z���Dc��T�q*Փ@:��d2��T�n��+8�H4� �x�v8{��0�&d�[�l��Ҏ@Ew��Pa�y��j-�j�/�u�ĩ�'�u�` �^̺�"���ٽ,�ޜ1�_\-@C�"-�A�"7�FWH�u���I�[\N��7X�\��a�_��.�K��` 0000468557 00000 n 0000004364 00000 n 0000479579 00000 n E-beam irradiation is similar to gamma processing in that electrons alter various chemical and molecular bonds in the exposed product, including within the DNA of microorganisms. 0000462761 00000 n 2 Table 3 considers the three major sterilization techniques and presents their respective characteristics. 0000042502 00000 n In order to remove of the residual gas (EO) or by-product (ethylene chlorohydrin [ECH], formed in the presence of chlorine ions), a heated aeration step is required. Ethylene oxide is compatible with many plastics. %PDF-1.3 %���� Temperature may increase slightly in the product due to ionization, but gamma sterilization may be effective at ambient, refrigerated, or even frozen conditions. The primary concern is to ensure the EO and ECH residues are within the allowable limits. 0000476753 00000 n It is also important to formally assess the potential effects of the sterilization process on product and packaging materials. 0000043699 00000 n 877.783.7479, Certifications | Privacy | Contact Us | Investor Relations | Careers | steris.com, Radiation Sterilization Validation Services, Method Development and Validation Services, Sterile Barrier Integrity and Seal Strength, Radiation Request Form Submittal Guidelines, STERIS AST Offers Medical Device Product Testing Capabilities to Support Our Global Expansions, STERIS is pleased to have collaborated with AAMI and medical industry leaders on an industrial sterilization publication, STERIS Announces Expansion of Chonburi, Thailand Facility to Include Gamma Processing, Ethylene Oxide (EO) – the residue that may remain after processing has been completed, Ethylene Chlorohydrin (ECH) – the residue that may form when EO comes into contact with free chloride ions, Ethylene Glycol (EG) – the residue that may form when EO comes into contact with water. The sterilization step occurs in a closed, airtight chamber, where vacuum is applied to remove air both to facilitate ethylene oxide diffusion and penetration and also to avoid explosive mixtures of ethylene oxide gas. Gamma sterilization may be performed on individual boxes, in irradiation containers usually referred to as totes, or on pallets. Many plastics fall into this category and EtO sterilization is frequently used for single use medical devices made of plastic. 0000679211 00000 n The polymers have various absorption, adsorption, and desorption properties. Gamma radiation is compatible with many plastics, all metals, and glass (subject to color change). Gamma irradiation is an ionizing radiation sterilization technique that involves exposing materials for sterilization to gamma rays. Interpower’s Ralph Bright defines these requirements and explains how to know which cord to select for your application. Tyvek® continues to be superior to medical-grade paper when strong, low-linting packaging is required. The nature of the reactions of these free radicals depends on the nature of the plastics, the presence of oxygen, the absence/presence of additives (antioxidants may be added to limit the free radicals), the dose applied to the material, and other environmental factors. Some polymers that are quite resistant to temperature, chemicals, and acids, such as PTFE, may be extremely sensitive to radiation. 0000677624 00000 n Ethylene oxide sterilization, known as EO or EtO sterilization, is one of the most common ways in which packaged medical devices are sterilized. After exposure to electron-beam radiation up to 100 kGy, Tyvek® maintains its superior microbial barrier and strength properties. First, you can select a specific O-ring material to view its compatible chemicals. o�U�U�&D��� �������牿d��[�;���뇎�W�d]�yꧽvER�"�0���:%>Sk�䨧҉� �:4�D([ƳṠ�T���(���[eBpen�U����������Ƒڈ��Z��E�����!�P*� �PBW�z�vn&ԩ���M���� @aU�ʚh��}�����pP�'�6u�ñw���x ICxӠ|G�B��E�D���jZ��}��_]������W͝D|����cRл �����F@Y�}��]��^�X��仹OA�aWMp�aGi��E� ���X����V}ٰ`#6��;�EH3>+��+�j�h�p2��(�:�j��s�:���l�Z3�Yh�d7���[��q!��j���aYY�6�$�)�7���>@3�Z�����!Ҡ5��3sTGřxz�V��5M��Y����+ 0000043154 00000 n The adsorbed EO is relatively easy to remove during the sterilization cycle, where absorbed EO is more difficult to eliminate. Ethylene Oxide [EO] 0000665925 00000 n 0000682344 00000 n 0000458116 00000 n 7&$���D���x8.g,n���Pڍ�`x��S�bR�]��t��$~�vi\Ljx}�RO��I �A��C���T8����Ñ��kK����R"��'�1�!�ϴ^��I������plW�'s|2�>�d�Vv\.��9}��k>0?4� 7wK[�k7��+�O�$Oڝ9o���4ҕ���.���09�6�����c� 0000478009 00000 n As part of our commitment to providing innovative and sustainable solutions, STERIS AST has developed the Sustainable EO® sterilization services program. 0000034462 00000 n Some plastics are degraded by autoclaving. The advantages and disadvantages, as well as its recommended uses, are explored in this review article. This can be done a few ways such as increasing the overall processing temperature set point or adding a moisture conditioning phase after the EO has been removed. 0000474573 00000 n Tyvek® 4057B is suitable for use with the STERRAD® Sterilization System from Advanced Sterilization Products (ASP), Division of Ethicon Inc., a Johnson & Johnson company. Many plastics fall into this category and EtO sterilization is frequently used for single use medical devices made of plastic. 0000467393 00000 n 3"��=����㔸�K,~� �?��ѩ�P�mX����kig�GC|��z>n�K��n�*`��\��U2��n�K���O�0b����4��õ�d|�3�E�§�bW�%���`TCO.c�̅�6�qY�W��F��>�Ù�r��#PM�����3l��[�k�h��'�܃�pc�X�#ޟ 0000481685 00000 n In addition, there are several special device categories that have their own unique set of limits. Nitrogen washes – all cycles will have a Nitrogen wash phase after the EO gas has been evacuated from the sterilization chamber.
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