First, you can select a specific O-ring material to view its compatible chemicals. 0000476177 00000 n The main side effect of using EO as a sterilization agent is that it can leave a residue on the devices being processed. 0000474573 00000 n 0000471447 00000 n 0000468163 00000 n 0000473664 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 0000472231 00000 n 0000479579 00000 n startxref Sterilizing medical devices with ethylene oxide (EO) is a common practice primarily due to its extensive material compatibility. Tyvek® retains its dimensional stability and integrity with no discoloration when steam sterilized under the controlled conditions mentioned above. This is because HDPE is radiation stable. Unlike medical-grade papers and films, DuPont™ Tyvek® offers sterilization compatibility with all of the most commonly used methods for sterilizing medical devices. 150 111 EO sterilization is typically a three-step process, starting with preconditioning in a room or cell, then sterilization in a chamber, and finally, desorption of gas in heated aeration in a room or cell. 0000475618 00000 n System Code No Component Parts Description Material Composition Steam Sterilization Compatibility Ethylene Oxide Compatibility VH2O2/O3 Compatibility Additional Comments Laparoscopic Trays DDLP-1123 Double Decker Lap Tray Anodized Aluminum Y CYSTO-224B Cysto Tray Anodized Aluminum Y DDLP-4113 Poly Double Decker Tray Radel Y ISO 9001:2015 Certified Companies 0000689567 00000 n 0000028563 00000 n =8�����Ť#۟〗'� 0000480844 00000 n This sterilization method uses low-temperature gas plasma to enable sterilization of heat-labile devices. 0000476753 00000 n Learn more about our global offering, which includes electron beam, gamma, X-ray, and ethylene oxide technologies, This TechTip provides a summary of minimizing over-processing by understanding how to establish an appropriate internal process challenge device. 0000665925 00000 n EO packaging. The chart in Figure 1 classifies the polymers by absorption and desorption characteristics. The chemical compatibility data can be presented in one of two ways. If residue issues are currently a problem or may present a challenge to a new device, consult with a sterilization provider to discuss minimizing the effects of the ethylene oxide sterilization process. 0000466256 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. The degree and types of changes to a particular plastic depend on the nature of the polymer, whether or not it has had stabilizers added to it during manufacture, the intensity of the radiation used and how long the parts are irradiated. 0000047330 00000 n Added heat – heat aids in the off-gassing process so it is helpful to keep as much heat in the chamber as possible after the sterilization process. The TCL is a calculated value that takes into consideration the surface area of a device and the EO and ECH residue levels in order to determine if irritation will be an issue. 0000046908 00000 n modalities and material compatibility with this modality ... • Can x-ray/e-beam be an alternative to ethylene oxide sterilization? Shrinkage of Tyvek® after steam sterilization is less than 1.6%. 0000043154 00000 n 0000685914 00000 n 6 Warner Road, Warner NH 03278 | P: (603) 456-2011 F: (603) 456.2012 Material Compatibility Material Steam Sterilizing Response Radiation Sterilizing Response Ethylene Oxide Sterilizing Response The final step is heated aeration, which is typically performed at temperatures between 40° and 50 °C, with air circulation. endstream endobj 151 0 obj <>]/PageLayout/SinglePage/Pages 147 0 R/Type/Catalog/ViewerPreferences<>>> endobj 152 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC/ImageI]/Shading<>/XObject<>>>/Rotate 0/TrimBox[0.0 0.0 595.276 841.89]/Type/Page>> endobj 153 0 obj [/ICCBased 179 0 R] endobj 154 0 obj [/Indexed 153 0 R 180 184 0 R] endobj 155 0 obj <> endobj 156 0 obj <>stream Temperature may increase slightly in the product due to ionization, but gamma sterilization may be effective at ambient, refrigerated, or even frozen conditions. Electron accelerators are capable of producing electron beams that are either pulsed or continuous. Products placed in non-breathable packaging. The information contained in this document is intended to provide guidelines for reference only. 877.783.7479, Certifications | Privacy | Contact Us | Investor Relations | Careers |, 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.