From: Clinical Engineering Handbook, 2004, W.J. It is used in drug synthesis and as a pesticide intermediate. EO has sterilized many polymers that could not be irradiated or heat sterilized. A drug applied through a plastic such as Taxol based-formulations cannot withstand high temperature and high humidity EO cycles. Gas concentration, sterilization temperature, chamber humidity, and exposure time affect EtO sterilization. Figure 2-5 presents a flow diagram for production of LDPE using the autoclave process. Highly toxic and reactive, EtO forms irreversible chemical bonds with bacteria, spores, and viruses, which disrupts critical homeostasis functions. EtO is a toxic gas that causes an internal chemical reaction in the microorganisms, which is generally ascribed to alkylating functional groups of enzymes, other proteins, and nucleic acids (Bruck and Mueller, 1988). The addition of alkyl groups to proteins, DNA, and RNA in micro-organisms prevents normal cellular metabolism and the ability to reproduce, which render micro-organisms nonviable. EO sterilization cycles must be designed to avoid conditions or parameters that may be explosive. The medical device is prepared and exposed to EtO in a sealed chamber, which may be up to 100% EtO at sub-atmospheric pressures (Dorman-Smith, 1997). After an EO process is complete, employees must take appropriate precautions to avoid exposure to EO gas, e.g., use of respirators when working in the vicinity of product that has not been fully aerated to dissipate the gas. <]>> Actively registered in the U.S. Ajay D. Padsalgikar, in Plastics in Medical Devices for Cardiovascular Applications, 2017. Ethylene, compressed oxygen and recycle gas are mixed and fed to a multi-tubular catalytic reactor. EtO sterilization has been commercially available since the 1980s (Bruck and Mueller, 1988). Ethylene oxide gas is toxic, carcinogenic, and very explosive. Ethylene oxide is used as a fumigant for spices, seasonings, and foodstuffs and as an agricultural fungicide. Choline chloride liquid (Aqueous Solution) is made by chemical synthesis. 0 HDPE may lose some tensile properties, no off-gassing, Polyethylene terephthalate glycol copolymer (PETG), Compatible, no discoloration; EO acceptable for contact lenses, Compatible. Ethylene oxide p… Gas concentration, moisture level (between 30–80%), and temperature (between 40–55 °C) must be carefully controlled throughout the process (around 2 hours) to ensure efficiency. R-701. PU has high affinity for EO but releases with aeration, Generally compatible, but changing curing method to sulfur cure from peroxide cure may result in formation of small amounts of polyethylene oxide inside the matrix of the material, Compatible, but may be limited to the number of repeat cycles, Good to excellent materials. Copyright © 2012 BINQ Machinery Company, Inc.    All rights reserved. EO gas (Fig. 0000000556 00000 n ETHYLENE — PROCESS FLOW DIAGRAMS Ethylene Steam Cracker Process Feed Furnace Section Feedstock Cracking Quench Separation Refrigeration Acid Gas Removal Compression & Condensation Steam Generation Ethylene Propylene Recycle Streams Fuel Gas Streams Quench Compression Decontamination Separation. It is considered to be one of the most versatile chemical intermediates owing to its high reactivity. P��p)��!.���(����O����~�����͖v�5A�-��έΉ�w���&C��V���-��vs��vc�[��=��s�:z6���&N+e�f\����!��\�N��mab%%e�4��R�,%%5�0������`|-(�X}�Vd`� ���X�����s��>�/a� T(&��à� � ���������;���s����?�̩*�. It is the base material for the production of several important products such as ethylene glycol, ethanol amines, organic insulating materials, and textile fibers. Standard EO cycles have high EO absorbency and poor desorption, requiring long aeration, Depending on formulation and application. A typical cycle of ETO sterilization is carried out between a temperature of 30°C and 60°C, a relative humidity of greater than 30%, and a gas concentration between 200 and 800 mg/L [67,69]. The exact amount of CO2 emissions associated with the ethylene oxide production is not easily available in the literature. S. Lerouge, in Metals for Biomedical Devices, 2010. ScienceDirect ® is a registered trademark of Elsevier B.V. ScienceDirect ® is a registered trademark of Elsevier B.V. URL: https://www.sciencedirect.com/science/article/pii/B9781845695774500041, URL: https://www.sciencedirect.com/science/article/pii/B978008087780800125X, URL: https://www.sciencedirect.com/science/article/pii/B9780122265709501253, URL: https://www.sciencedirect.com/science/article/pii/B978032335401100003X, URL: https://www.sciencedirect.com/science/article/pii/B9781845694340500139, URL: https://www.sciencedirect.com/science/article/pii/B9780128137345000561, URL: https://www.sciencedirect.com/science/article/pii/B9781845692452500172, URL: https://www.sciencedirect.com/science/article/pii/B9781455731480000054, URL: https://www.sciencedirect.com/science/article/pii/B9780323358859000047, The effects of sterilization on medical materials and welded devices, Joining and Assembly of Medical Materials and Devices, ), except those that may be particularly sensitive to humidity, low temperature, and high EO gas concentration EO sterilization is nearly always very gentle with most polymers, if used wisely. Annual global CO 2 emissions caused by the ethylene oxide industry are estimated to be around 5.1 Mt [109]. It is soluble in water to 10°C, and it forms polyglycols in the presence of bases. Annual global CO2 emissions caused by the ethylene oxide industry are estimated to be around 5.1 Mt [109]. 60 0 obj<> endobj Some of the limitations related to EO may also relate to polymers’ ethylene oxide absorptivity to accumulating residuals, but this will vary significantly depending upon humidity, EO gas concentration, temperatures, and aeration. May be some long-term effect on tensile modulus. 0000002319 00000 n In this case, if there is a hole in the chamber, the gas will not escape easily. with ethylene oxide ranking twenty-seventh ( billion pounds in ….. An important feature of the process is the negligible production of diethylene glycol (DEG) and triethylene glycol (TEG), which occur as byproducts in other ethylene glycol production processes. However, because of its toxicity and hazardous residues, EtO sterilization is conducted in accordance with domestic and international standards [23,24]. Some formulations may be subject to stress cracking and some loss of tensile properties after multiple cycles and an extended time post-processing, no discoloration, Polyethylene (PE, UHMWPE, LDPE, LLDPE, HDPE), Generally compatible. trailer EO is compatible with nearly every polymer, and if there is a problem with the polymer because of the technique, there typically is an expert solution.

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