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<p>Этиленоксид (ЭО), часто обозначаемый как "EtO", является органическим соединением, которое при нормальной комнатной температуре существует в виде бесцветного газа с слегка сладким запахом. Его молекулярная нестабильность делает его высокореактивным, что делает его легковоспламеняющимся и взрывоопасным в различных концентрациях. Однако эта же реакционность позволяет этаноксиду эффективно нарушать ДНК микроорганизмов, предотвращая их размножение и вызывая гибель клеток. ЭО совместим с широким спектром материалов и не оставляет остатков, что делает его идеальным для стерилизации медицинских изделий и для обработки сельскохозяйственной продукции и ценных документов.</p>
<p>Этиленоксид служит эффективным стерилизующим средством для продуктов, не переносящих высоких температур, влаги или агрессивных химических веществ, а также для продуктов, подвергшихся воздействию радиации. Более 50% медицинских изделий по всему миру стерилизуются с использованием процесса газовой стерилизации этиленоксидом.</p>
<p>Процесс газовой стерилизации Продукция упаковывается в материал с дышащим барьером, позволяющим диффузии газа этиленоксида, но блокирующим микроорганизмы. Предварительное условие повышает температуру материала и уровень влажности, улучшая эффективность стерилизации. Процесс происходит в герметичной вакуумной камере при контролируемых условиях, обеспечивающих стерильность. Последующие циклы дегазации удаляют остаточный ЭО, делая продукцию безопасной для извлечения.</p>
<p>Преимущества газовой стерилизации Газовая стерилизация подходит для продуктов, совместимых с ЭО и упакованных с дышащим микробным барьером. Типичные продукты включают имплантируемые устройства, медицинскую трубку, повязки, хирургические принадлежности, электронное оборудование и сельскохозяйственные товары.</p>
<p>Процесс газовой стерилизации этиленоксидом широко используется в здравоохранении уже более 70 лет благодаря его эффективности, экономичности и совместимости с широким спектром материалов.</p>

Eo Steriliation Advantage

<p>The 89th China International Medical Equipment Fair (CMEF) successfully concluded on April 14, 2024, at the Shanghai National Convention and Exhibition Center. As a globally leading medical and health technology platform covering the entire industry chain, CMEF continuously empowers the industry with technology, drives innovation, and provides opportunities for cooperation and exchange for a wide range of participants!</p>
<p><img src="https://us1.yofishseo.com/file/2/微信图片_202404150957532.png" alt="微信图片_202404150957532.png"></p>
<p>At this exhibition, hzbocon's main product, the "Ethylene Oxide Sterilizer," made a splendid appearance at the CMEF booth, attracting a continuous stream of inquiries on-site. Our professional marketing team provided detailed product introductions and technical explanations to interested visitors, who could be seen engaging in lively discussions at the negotiation area, in front of the booth, and beside the products.</p>
<p><img src="https://us1.yofishseo.com/file/2/新建项目-(22).png" alt="新建项目 (22).png"></p>
<p>During the 4-day CMEF exhibition, we had the privilege to share cutting-edge technologies and exchanges with professionals from around the world. The vibrant atmosphere on-site showcased the strong and dynamic vitality of the medical equipment industry! Here, hzbocon expresses gratitude to every visitor for their presence. It is through your interactions and sharing that our products, technologies, and latest achievements are presented more comprehensively within the industry!</p>
<p><img src="https://us1.yofishseo.com/file/2/新建项目-(24).png" alt="新建项目 (24).png"></p>

Hzbocon In 89th Cmef Show

<p>This future plan aims to drive the ETO sterilizer factory(hzbocon) towards enhanced operational efficiency, environmental responsibility, and technological advancement while prioritizing safety and quality assurance.</p>
<h2>Technological Upgrades &nbsp;</h2>
<p>Automation: Implement advanced automation in the sterilization process to improve efficiency and reduce human intervention.<br>IoT Integration: Incorporate Internet of Things (IoT) devices for real-time monitoring and maintenance of ETO sterilization equipment.<br><br></p>
<h2>Environmental Impact Emission Control:&nbsp;</h2>
<p>Invest in emission control technologies to minimize the release of ethylene oxide into the environment.</p>
<h2>Safety Measures Employee Training:&nbsp;</h2>
<p>Provide comprehensive training programs to ensure that employees are well-versed in handling ETO safely and effectively. Safety Protocols: Review and update safety protocols to meet or exceed industry standards, prioritizing worker safety.</p>
<h2>Regulatory Compliance Adherence to Standards:</h2>
<p>Stay updated with the latest regulatory requirements related to ETO sterilization and ensure full compliance in all operations.</p>
<h2>Quality Assurance Process Optimization:</h2>
<p>Continuously improve sterilization processes to enhance product quality while maintaining efficiency. Quality Control Systems: Implement robust quality control systems to ensure consistent and reliable sterilization outcomes.</p>

Eto Sterilizer Manufacturer Bocon Future Plan

<p>Hangzhou Bocon Mechanical And Electrical Equipments Co., Ltd, was established in 2006. Our company is a high-tech enterprise that multifunctionally and comprehensively comprises research, development, production, sales, and international patent certification. Our company insists on innovation, emphasis on service, and concentrates on quality. Customer primary, quality utmost, and credit paramount are our longtime insistent policy.</p>
<p>&nbsp;</p>
<h2>BOCON History</h2>
<p>&nbsp;</p>
<h2>&nbsp;</h2>
<h2>BOCON Marketing</h2>
<p>Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd., developed &amp; researched the Ethylene Oxide (following: EO) sterilizer in 2006, till now we have produced the equipment for over 18 years. &nbsp;We already passed the ISO9001-2008, ISO13485-2003, and CE, which provide a reliable guarantee for the quality of our products. &nbsp;Our products have already been exported to Japan, Pakistan, Cambodia, Egypt, Uzbekistan, Iran, South Africa etc. &nbsp;The market share rate increasing year by year.</p>
<p>&nbsp;</p>
<p>&nbsp;</p>
<h2>BOCON Project</h2>
<p>BOCON has done many large size eto sterilizer project in china and other country</p>
<p>&nbsp;</p>
<p>&nbsp;</p>
<p>&nbsp;</p>
<p>&nbsp;</p>
<h2>BOCON Certificate</h2>
<p>&nbsp;</p>
<p>&nbsp;</p>
<h2>BOCON &nbsp;Partner</h2>
<p>&nbsp;</p>
<p>We have established partnerships with many renowned medical enterprises in the industry, aiming to enhance and expand collaborations for mutual benefit. Our joint efforts with these prestigious healthcare companies are geared towards fostering innovation and driving positive impacts in the medical field</p>
<p>&nbsp;</p>
<p>&nbsp;</p>
<p>&nbsp;</p>

Eto Sterilizer Manufacturer In Market

<p>An ETO (Ethylene Oxide) sterilizer is a critical medical device utilized to disinfect and sterilize sensitive equipment and materials in healthcare and pharmaceutical industries. It utilizes ethylene oxide gas to penetrate and eliminate bacteria, making it ideal for items intolerant to conventional high-heat sterilization techniques.</p>
<p>When considering the purchase of this equipment for your laboratory, it's essential to order from one of the top ETO Sterilizer Manufacturers. Before making a purchase, thoroughly examine the features of the equipment.</p>
<h2>Benefits of ETO Sterilizers</h2>
<p><strong>Disinfection and Gentle Sterilization:</strong><br>The ETO sterilizer plays a pivotal role in gently sterilizing delicate and heat-sensitive medical equipment and materials, ensuring product integrity and microbial removal without compromising quality.</p>
<p><strong>Microbial Eradication:</strong><br>It effectively eradicates bacteria by penetrating materials, reaching inaccessible areas, and thoroughly disinfecting medical equipment, essential for infection management in healthcare settings.</p>
<p><strong>Material Compatibility:</strong><br>Essential for safeguarding heat-sensitive and delicate items like medical devices, plastics, and electronics, contributing to comprehensive sterilization without impacting material integrity.</p>
<p><strong>Versatile Applications:</strong><br>Its adaptability makes it indispensable across diverse sectors, including healthcare, pharmaceuticals, and manufacturing industries, due to its capacity to clean a variety of objects.</p>
<p><strong>Sterilization Cycle Management:</strong><br>Provides meticulous control over sterilization cycles, ensuring uniform results and thorough microbial elimination across diverse applications.</p>
<p><strong>Aseptic Packaging Contribution:</strong><br>Contributes to aseptic packaging, ensuring product integrity and minimizing contamination risk, crucial in safeguarding patient safety in medical environments.</p>
<p><strong>Residue Reduction:</strong><br>Minimizes the residue following the sterilization process, maintaining product safety and reducing potential health risks.</p>
<p><strong>Compliance Assurance:</strong><br>Guarantees adherence to stringent guidelines established by regulatory bodies, ensuring safety, efficacy, and quality in medical and industrial applications.</p>
<h4>Tips for Choosing the Best<a href="https://www.hzbocon.com/"> ETO Sterilizer Manufacturer</a></h4>
<p><strong>Thorough Research:</strong><br>Research nearby companies offering top-quality medical equipment or laboratory products and ask relevant questions to ensure reliability.</p>
<p><strong>Testimonials and Reviews:</strong><br>Check customer testimonials and reviews on the company's website to gauge product quality, customer service, and overall satisfaction levels. <a href="https://www.hzbocon.com/">reliable manufacturer.</a>&nbsp;</p>

Ethylene Oxide (ETO) Sterilizer: Benefits And Tips For Choosing A Manufacturer

<h2><img src="https://first-fish.oss-us-west-1.aliyuncs.com/file/2/logo.png" alt="LOGO.png"></h2>
<p>Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd. developed and researched the Ethylene Oxide (EO) sterilizer in 2006, and since then, we have been producing this equipment for over 18 years. We have obtained ISO9001-2008, ISO13485-2003, and CE certifications, providing a reliable guarantee for the quality of our products. Our products have already been exported to various countries, including Japan, Pakistan, Cambodia, Egypt, Uzbekistan, Iran, and South Africa. Our market share has been increasing year by year.</p>
<p>We take every customer and every order seriously as our duty, aiming to meet customer requirements at every stage, from procurement to semi-finished production, welding, assembly, testing, and experiment monitoring. We strictly follow the ISO 13485:2016 quality management system control program.</p>
<h2><strong>Turnkey Project for Ethylene Oxide Sterilization</strong></h2>
<p>Specializing in the design, manufacture, control, and qualification of Ethylene Oxide Sterilizers (EO/ETO), we cater to the sterilization of thermosensitive products such as syringes, catheters, dialysis cartridges, plastic dressings, and sutures&mdash;items sensitive to heat and humidity. As a manufacturer of ethylene oxide sterilizers, we provide an ideal method for medical device sterilization. Additionally, we offer all the necessary ancillary equipment to create a complete sterilization unit using the ethylene oxide process.</p>
<h2><strong>Ethylene Oxide Sterilization Chambers - EO Machine</strong></h2>
<p>Our modular design divides the risk area, reducing the potential for a hazardous atmosphere, and is customizable to meet client requirements. Our chambers are equipped to work with either an "All in One" cycle or with preconditioning and degassing cells. We also provide all the necessary ancillary equipment for turnkey projects.</p>
<h2><strong>Safety of Our EO Sterilization Equipment</strong></h2>
<p>Safety is our top priority for both personnel and sterilization equipment. Our PLC incorporates special safety modules and is programmed together with SCADA according to the HAZOP of each project. Furthermore, multiple safety measures, including 3 redundant safeties for any critical function (PL/SIL), automatic calculation of the flammable diagram, and the use of flame arrestors, are integrated into the design.</p>
<h2><strong>Quality Policy: Reputation from Lasting Quality!</strong></h2>
<p>We believe in earning reputation through lasting quality and achieving performance through constant pursuit. In 2010, we developed a preheating cabinet which we successfully introduced to the market. Subsequently, we developed the preheating, sterilization, and aeration one-body cabinet and obtained a patent for it. Simultaneously, we also developed the manufacturing preheating room, aeration room, automatic transmission system of EO sterilizer, and EO tail gas treatment system&mdash;all of which have been sold and utilized, leaving a positive impression on our customers.</p>

Eto Sterilizer Manufacturer-hzbocon

<p>We are waiting for you in Russian Healthcare Week 2023</p>
<p class="MsoNormal"><strong><span class=" __aliyun_node_has_color __aliyun_node_has_bgcolor">Our&nbsp;Booth is no.&nbsp;&nbsp;25С25.</span></strong></p>
<p class="MsoNormal"><span class=" __aliyun_node_has_color __aliyun_node_has_bgcolor">Welcome to visit our booth.</span></p>
<p><img src="https://first-fish.oss-us-west-1.aliyuncs.com/file/2/微信图片_20231205122002.jpg" alt="微信图片_20231205122002.jpg" width="800"></p>

Hzbocon In Russian Health Week(First Day)

Hangzhou Bocon In RUSSIAN HEALTH CARE WEEK

OPERATIONAL QUALIFICATION PROTOCOL For HZBOCON& Fengtai 98.6 M 3Size ETO Sterilizer

<h2>1. PURPOSE</h2>
<div>1.1 To verify and document the proper installation of the new ETO Sterilizer (Serial Number: 201346 and</div>
<div>Model: HMQ-100) and any ancillary items have been supplied and installed in accordance with their INSTALLATIONAL QUALIFICATION PROTOCOL</div>
<div>For HZBOCON&amp; Fengtai 98.6 M 3Size ETO Sterilizer (S/N: 201346)</div>
<div>Used to sterilize Medical Devices Products</div>
<div>&nbsp;</div>
<div>specification.</div>
<div>This protocol defines the Installation Qualification (IQ) requirements and the corresponding acceptance</div>
<div>criteria for the 98.6 m 3 ETO Sterilizers which installed at ETO sterilization facility of medical product</div>
<div>Co., LTD., which is located in XXX.</div>
<div>&nbsp;</div>
<div>
<h2>2. BACKGROUND</h2>
<div>2.1 In order to expand capacity, A new 98.6 m 3 ETO sterilizers is added and installed in ETO sterilization</div>
<div>facility of XXX Co., LTD , XXX . xxx will use it to sterilize medical products.</div>
<div>2.2 The sterilizer is a 98.6 cubic meter chamber manufactured by Hangzhou Bocon Mechanical &amp;Electrical</div>
<div>Equipment co.Ltd and Beijing Fengtai Yongding Disinfection Equipment Factory. It is water-jacketed</div>
<div>with gas circulation system, it use 100% ETO gas as sterilizing agent, The sterilizer hold thirty (30)</div>
<div>pallets of size L1000mm x W1200mm x H120mm and the inner size of chamber is L16600mm x</div>
<div>W2700mm x H2200mm.</div>
<div>2.2 IQ study</div>
<div>2.2.1 Safety review of all parameters and decisions to operate the chamber under any operating</div>
<div>conditions.</div>
<div>&nbsp;</div>
<div>
<h2>3. REFERENCE</h2>
<div>3.1 ISO11135-1:2007 Sterilization of health care products &mdash; Ethylene oxide &mdash; Part 1: Requirements for</div>
<div>development, validation, and routine control of a sterilization process for medical devices</div>
<div>3.2 ISO11135-2:2008 Sterilization of health care products &mdash; Ethylene oxide &mdash; Part 2: Guidance on the</div>
<div>application of ISO 11135-1</div>
<div>3.3 AAMI TIR15:2009 Physical aspects of ethylene oxide sterilization</div>
<h2>4. RESPONSIBILITIES</h2>
<div>4.1 Sterilization validation department</div>
<div>4.1.1 Sterilization Engineer will draft installation qualification protocol, gather supporting</div>
<div>documentation &amp; data and review, write final validation technical report.</div>
<div>4.1.2 QA director will review and approve validation protocol and final technical report.</div>
<div>4.2 Testing center</div>
<div>4.2.1 Responsible calibration personnel will prepare calibration procedure and complete calibration of</div>
<div>all relevant measuring device before installation qualification.</div>
<div>4.3 Equipment department</div>
<div>4.3.1 Install, set-up, and operate equipment for purposes of this study. Provide relevant equipment</div>
<div>information, documentation and drawing for IQ,</div>
<div>4.3.2 Inspect and accept sterilizer hardware and software according to purchase technical contract;</div>
<div>4.3.3 Provide technical support for any utility related issue.</div>
<div>4.4 ETO sterilization center</div>
<div>4.4.1 Technician: Provide process and equipment documentation, provide technical support.</div>
<div>4.4.2 Operator: Assist for inspect equipment and collect relevant evidence.</div>
<div>4.1.3 Vice general manager: Review and approve validation protocol and final technical report.</div>
<div>&nbsp;</div>
<div>
<h2>5. DEVIATION AND CHANGE CONTROL</h2>
<div>5.1 Deviation and/or change may happen during the qualification process. If it occurs, a corresponding</div>
<div>deviation form on Attachment A will be completed and submitted to the validation engineer for</div>
<div>disposition. The deviation form will describe the deviation / change, the impact to validation, resulting</div>
<div>investigation, and action. The deviation form will be reviewed for acceptability and approved by the</div>
<div>personnel responsible for protocol approval. The deviation form will be the part of the validation report</div>
<div>for final determination.</div>
<div>&nbsp;</div>
<div>
<h2>6. TEST INSTRUMENTS AND MATERIAL</h2>
<div>6.1 Sterilizer#17 (internal asset number: F2-EMJ-017) and ancillary system.</div>
<div>&nbsp;</div>
<h2>7. INSTALLATION QUALIFICATION PROCEDURE</h2>
<div>7.1 The following Installation Qualification sections will detail the documentation required to verify that the</div>
<div>installation of the EO sterilizer according to the manufacturer&rsquo;s recommendations and the approved</div>
<div>design specifications.</div>
<div>7.2 Equipment Documentation</div>
<div>7.2.1 List all of the documentation that drove the design, purchase and installation of the sterilizer in</div>
<div>Attachment B-1 &amp; B-2. Check the following requirements:</div>
<div>7.2.1.1 Drawings of the equipment installed, and other ancillary equipment. (System map of</div>
<div>sterilizer, installation sketch map of sterilizer, pipeline marking schedule, etc)</div>
<div>7.2.1.2 Building Drawings of equipment (show the installation location)</div>
<div>7.2.1.3 Purchase Orders</div>
<div>7.2.1.4 Manual (may include operating instruction, installation instruction, safe operation</div>
<div>regulation of sterilizer, maintenance guide of sterilizer, normal malfunctions and</div>
<div>troubleshooting of the sterilizer, etc)</div>
<div>7.2.2 Document the following information into attachment B-1 where applicable</div>
<div>7.2.2.1 Title</div>
<div>7.2.2.2 Document Number</div>
<div>7.2.2.3 Issue Date</div>
<div>7.2.2.4 Revision Number</div>
<div>7.2.2.5 Location</div>
<div>7.2.3 Acceptance Criteria: All drawings / Documents must accurately represent the machine as</div>
<div>installed. Make note in the following table if any changes were made to the individual drawings</div>
<div>or documents.</div>
<div>7.3 Standard Operating, Cleaning, Calibration and Maintenance Procedures</div>
<div>7.3.1 Allmed shall establish and implement procedure to assure the equipment operation and</div>
<div>maintenance under control.</div>
<div>7.3.2 The responsible personnel at Allmed will establish corresponding standard operating, cleaning,</div>
<div>calibration and maintenance procedures based on training, experience, and any</div>
<div>recommendations from the equipment supplier. List all SOP&rsquo;s in Attachment B-2. Document</div>
<div>the following where applicable.</div>
<div>7.3.2.1 SOP Number</div>
<div>7.3.2.2 Title</div>
<div>7.3.2.3 Version Number / Effective Date</div>
<div>7.3.2.4 SOP Location</div>
<div>7.3.3 Acceptance Criteria: All SOP&rsquo;s needed for the operation, cleaning, calibration and</div>
<div>maintenance of the chamber must exist.</div>
<div>7.4 Spare Parts List</div>
<div>7.4.1 The responsible personnel at Allmed will develop spare parts list, based on training,</div>
<div>experience, and any recommendations from the equipment supplier. Appropriate spare parts</div>
<div>shall be ordered. List the spare parts in Attachment B-3, or attach the equivalence report to</div>
<div>Attachment B-3 is also acceptable.</div>
<div>7.4.2 Acceptance Criteria: spare parts has been listed and ordered.</div>
<div>7.5 Calibration</div>
<div>
<div>7.5.1 All sterilizer monitor, controls, indicator or record parameters (time, temperature, humidity,</div>
<div>pressure, etc.) and test instruments shall be identified and criticality determined.</div>
<div>7.5.2 Non-critical instrumentation shall be identified and indication of labeling as &ldquo;Not Calibrated&rdquo;.</div>
<div>The following instrumentations shall be considered non-critical:</div>
<div>7.5.2.1 Steam Pressure Gauge, at steam generator, monitors the steam pressure</div>
<div>7.5.2.2 Compressed Air Pressure Gauge, at compressed air entrance piping, monitor the</div>
<div>Pressure of the compressed air.</div>
<div>7.5.2.3 EO Gas Pressure Gauge, at EO entrance pipe, monitors the pressure of the ETO gas</div>
<div>7.5.2.4 Hot Water Pressure Gauge, at hot tank entrance and exit, monitor water entrance</div>
<div>and exit pressure.</div>
<div>7.5.2.5 Nitrogen Pressure Gauge, at nitrogen stage tank, monitor nitrogen stage tank</div>
<div>pressure.</div>
<div>7.5.2.6 Vacuum pressure gauge, within wind circulation piping.</div>
<div>7.5.2.7 Other gauges</div>
<div>7.5.3 Critical instrumentation must be calibrated traceable to a national standards institute. All test</div>
<div>equipment used in IQ shall be calibrated before validation studies. The following</div>
<div>instrumentations are known and shall be considered critical:</div>
<div>7.5.3.1 Temperature sensors: Two (2) as a whole are within chamber, one (1) is within</div>
<div>vaporizer and one (1) is in EO gas injection inlet.</div>
<div>7.5.3.2 Humidity sensor: Two (2) are within circulation main piping.</div>
<div>7.5.3.3 Pressure sensor: Two (2) are within chamber.</div>
<div>7.5.3.4 ETO tank scale: One (1) is specially used for the sterilizer.</div>
<div>7.5.4 Verify and document that all critical instrumentation has been introduced into the calibration</div>
<div>program. List all critical instruments and devices with their accuracy, precision, range,</div>
<div>calibration due date into sheet Attachment B-4, or attach the equivalent report to Attachment</div>
<div>B-4 is also acceptable.</div>
<div>7.5.4.1 Instrument Name</div>
<div>7.5.4.2 Model Number</div>
<div>7.5.4.3 Serial Number</div>
<div>7.5.4.4 Range</div>
<div>7.5.4.5 Precision</div>
<div>7.5.4.6 Calibration Certificate No.</div>
<div>7.5.4.7 Calibration Due Date</div>
<div>7.5.5 Acceptance Criteria</div>
<div>7.5.5.1 Each instrument must be in compliance with the Calibration Program. Each critical</div>
<div>instruments must be within the calibration due date and the calibration should be</div>
<div>effective.</div>
<div>7.5.5.2 A response of &ldquo;Yes&rdquo; is required for items which require a Yes / No response.</div>
<div>7.5.5.3 Any response of &ldquo;No&rdquo; must be explained in the comments section.</div>
<div>7.6 Installation inspection</div>
<div>7.6.1 Complete Attachment C which defines the information of the sterilizer. Document the following</div>
<div>where applicable:</div>
<div>7.6.1.1 Manufacturer</div>
<div>7.6.1.2 Model Number</div>
<div>7.6.1.3 Serial Number</div>
<div>7.6.1.4 Asset Number</div>
<div>7.6.1.5 Location</div>
<div>
<div>7.6.1</div>
<div>Verify that equipment is compliance with installation specifications which described below and</div>
<div>document in Attachment C. Attach the drawings which show the installation location and</div>
<div>requirements of these parts.</div>
<div>7.6.2.1 Chamber construction: check the constructions materials of the inner wall of the</div>
<div>chamber, the material shall be made of stainless steel，the inner size of chamber is</div>
<div>L16600mm x W2700mm x H2200mm.</div>
<div>7.6.2.1 Load door and unload door: check the constructions materials of the inner wall</div>
<div>of the doors, the material shall be made of stainless steel, Doors are lifted by</div>
<div>Pneumatic jacks that are operated by pushbuttons mounted on the side of the</div>
<div>chamber. Once the doors have been lifted they can then be manually swung open.</div>
<div>7.6.2.2 Silicone gaskets with internal inflatable type are fitted between both the load and</div>
<div>unload door, a gaskets are equipped into groove of door frame for each door. when</div>
<div>start sterilizer, nitrogen gas inflate gasket, the door and chamber keep seal, when</div>
<div>complete run, deflate gasket, the seal is relieved, the door can be opened.</div>
<div>7.6.2.3 Temperature sensors: Two (2) as a whole are within chamber, one (1) is within</div>
<div>vaporizer and one (1) is in EO gas injection inlet.</div>
<div>7.6.2.4 Humidity sensors: Two (2) are within circulation main piping</div>
<div>7.6.2.5 Pressure sensors: Two (2) are within chamber</div>
<div>7.6.2.6 ETO cylinder scale: One (1) is specially used for the sterilizer</div>
<div>7.6.2.7 Infrared ETO gas analyzer: One (1) is within chamber</div>
<div>7.6.2.8 Compressed air supply piping: check the pressure of the compressed air, Check the</div>
<div>joint of the compressed air supply piping. The joint of the piping shall be integrated.</div>
<div>7.6.2.9 EO piping: check the construction materials of piping from EO steel cylinder to joint</div>
<div>piping inside the chamber, the pipe must be made of stainless steel. The joint of the</div>
<div>piping shall be integrated.</div>
<div>7.6.2.10 Humidifying piping: check the construction materials of piping from steam generator</div>
<div>to steam sprayer inside the chamber, the piping must be made of stainless steel. The</div>
<div>joint of the piping shall be integrated.</div>
<div>7.6.2.11 Electric control cabinet: used to control the sterilization process manually, the electric</div>
<div>Control cabinet shall be installed properly.</div>
<div>7.6.2.13 Frequency converter: used to control revolution speed of electric machinery of</div>
<div>vacuum pump so that control vacuum speed by frequency converting.</div>
<div>7.6.2.14 Steam generator: used to generate steam which add into the chamber and improve</div>
<div>chamber humidity, the steam generator shall be installed properly. The joint of the</div>
<div>piping shall be integrated.</div>
<div>7.6.2.15 EO vaporizer: used to vapor EO and maintain EO gas at a higher temperature, the</div>
<div>EO vaporizer shall be installed properly. The joint of the piping shall be integrated.</div>
<div>7.6.2.16 Hot water supply system: used to generate hot water which will flow through the</div>
<div>piping inside the jacket of the chamber, and heating sterilization chamber. The hot</div>
<div>water tank shall be installed properly. The joint of the piping shall be integrated.</div>
<div>7.6.2.17 HEPA filter: A filter to be used to filter air when air is injected into chamber, A filter to</div>
<div>be used to filter steam when steam is injected into chamber, the two filter meet</div>
<div>specific requirements of relevant standards（Brand: PALL, 0.3&mu;m or better）The joint</div>
<div>of the piping shall be integrated.</div>
<div>7.6.2.18 Vacuum system (including vacuum pumps, chiller and piping): used to vacuum the</div>
<div>chamber, the vacuum shall be installed properly. The joint of the pipes shall be</div>
<div>integrated.</div>
<div>
<div>7.6.2.19Gas circulation system, Two (2) fans (each single fan has the flow rate of 2500m3 /h)</div>
<div>to allow a gas circulation flow inside the chamber of 50 chamber volume/hour. The</div>
<div>fans are explosion-proof.</div>
<div>7.6.2.20Exhaust system, A exhaust fan is installed the top of chamber which near to load door,</div>
<div>when unload door is opened, the exhaust fan start, draw out air with residual EO gas</div>
<div>within chamber to protect operator. The joint of the piping shall be integrated.</div>
<div>7.6.2.21There are two (2) main circulation wind piping on top of chamber, each main wind</div>
<div>piping have a flow rate switch, each main wind piping connect a circulation fan, fan</div>
<div>connect chamber circulation wind inlet, each main wind piping have four (4) outlet</div>
<div>which connect chamber circulation wind outlet, so the chamber have two (2)</div>
<div>circulation wind inlet and eight (8) circulation wind outlet, the joint of the piping shall</div>
<div>be integrated.</div>
<div>7.6.2.22EO exhaust, emission control and abatement systems: use acid to treat EO gas, the</div>
<div>joint of the piping shall be integrated.</div>
<div>7.6.2.23Notrigen generator is installed and the joint of the piping from sterilizer to nitrogen</div>
<div>storage tank shall be integrated</div>
<div>7.6.2.24There are forty-nine (49) water jacket distributed in chamber and five (5) water jacket</div>
<div>distributed in each door.</div>
<div>7.6.2.25There are three(3) pump installed in the top of chamber, one(1) is vacuum pump</div>
<div>which is used to chamber vacuum; one(1) is hot water circulation pump which is used</div>
<div>to promote circulation of water within chamber and door water jacket; one(1) is</div>
<div>gasification pump which is used to promote circulation of water within vaporizer.</div>
<div>7.6.2.26Process automation computer system: the installation of two (2) computer shall meet</div>
<div>the requirements; each computer has a citect software keys，one is as control</div>
<div>computer and the other is as monitor computer.</div>
<div>7.6.2.27In-touch software is used to control sterilizer run and MES software is used to collect</div>
<div>date derived from PLC to generate form, software is validated and authorized to</div>
<div>Allmed and Backup.</div>
<div>7.6.2.28Physical damage and integrity: The sterilizer and all auxiliary equipments shall be</div>
<div>inspected to ensure that it is intact with no visible signs of loose parts or physical</div>
<div>damage. Document all findings on the documentation form.</div>
<div>7.6.2.29Electrical power: check the electrical power supply for the chamber and all ancillary</div>
<div>items. The power voltage shall comply with requirements from the equipment supplier.</div>
<div>Document the findings on Attachment C.</div>
<div>7.6.2.29.1 Electric control cabinet: AC 380V, 50Hz</div>
<div>7.6.2.29.2 Frequency convertor: AC 380V, 50Hz</div>
<div>7.6.2.29.3 Computer system: AC 220V, 50Hz</div>
<div>7.6.2.29.4 Vacuum pump: AC 380V, 50Hz</div>
<div>7.6.2.29.5 Steam generator: AC 380V, 50Hz</div>
<div>7.6.2.29.6 Chiller: AC 380V, 50Hz</div>
<div>7.6.2.29.7 Nitrogen generator: AC 380V, 50H</div>
<div>7.6.2.29.8 EO gas abatement system: AC 380V, 50Hz</div>
<div>7.6.2.29.9 Hot water circulation pump: AC 380V, 50Hz</div>
<div>7.6.2.29.10 Gas circulation fan: AC 380V, 50Hz</div>
<div>7.6.2.29.11 Exhaust fan：AC 380V, 50Hz</div>
<div>7.6.2.29.12 Gasification pump: AC 380V, 50Hz</div>
<div>7.6.3 Acceptance Criteria</div>
<div>7.6.3.1 Instrument should be compliance with the specification.</div>
<div>&nbsp;</div>
<div>
<div>7.6.3.2 All utilities necessary for system operation must be connected to the machine and must</div>
<div>be present at the levels required to operate the machine.</div>
<div>7.6.3.3 A response of &ldquo;Yes&rdquo; is required for items which require a Yes / No response.</div>
<div>7.6.3.4 Any response of &ldquo;No&rdquo; must be explained in the comments section.</div>
<div>7.7 Sub-system of Sterilizer Environment Installation Check</div>
<div>7.7.1 Check the environment of the sterilizer according to attachment D and record the result onto</div>
<div>Attachment D.</div>
<div>7.7.2 Check the installation of all sun-systems for the sterilizer according to Attachments E1~E5, and</div>
<div>record the result onto Attachments E1~E5.</div>
<div>7.7.3 Check the job qualification of operators attend this validation follow the requirements in</div>
<div>Attachment F and document the result onto it also.</div>
<div>8 INSTALLATION QUALIFICAITON REPORT</div>
<div>8.1 Installation report will be written, clearly showing how the acceptance criteria of this protocol were met.</div>
<div>If there were any deviations from the protocol, then the completed deviation forms must be included in</div>
<div>the report. The report will be reviewed and approved by Allmed.</div>
<div>&nbsp;</div>
<div>&nbsp;</div>
<div>
<p>Attachment A<br>Protocol Deviation Form<br>(Use additional sheets if needed)<br>Protocol # and Title:<br>Section of Protocol Deviated from:<br>Machine# involved in the Deviation:<br>1. &nbsp;Describe the deviation:</p>
<p><br>2. &nbsp;Describe how the deviation impacts the qualification:</p>
<p><br>3. &nbsp;Investigation of the deviation:</p>
<p><br>4. &nbsp;Corrective action taken:</p>
<p>&nbsp;</p>
<p>Deviation Form completed by / Date:<br>Deviation Reviewed by / Date:<br>Deviation Approved by / Date:</p>
</div>
</div>
</div>
</div>
</div>
</div>
</div>
</div>
</div>

Installational Qualification Protocol For 100m3 Eto Sterilizer

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<p>Ethylene oxide (EtO) is a widely used sterilizing agent, particularly in the medical field, due to its effectiveness in sterilizing a broad range of materials without compromising their integrity. This gas is especially valuable for sterilizing items that are sensitive to heat and moisture, which cannot withstand traditional sterilization methods such as steam or dry heat. Here, we will explore the various products and materials that are commonly sterilized using ethylene oxide, highlighting its critical role in ensuring the safety and efficacy of medical devices and other products.</p>
<h3>Medical Devices</h3>
<p>Ethylene oxide is predominantly used in the sterilization of medical devices. Approximately 50% of all medical devices are sterilized using EtO, making it an indispensable method in the healthcare industry. The following are some of the medical devices that are typically sterilized with ethylene oxide:</p>
<ol start="1">
<li>
<p><strong>Fiberoptic Endoscopes</strong>: These delicate instruments require sterilization methods that do not damage their intricate components.</p>
</li>
<li>
<p><strong>Surgical Kits and Instruments</strong>: Including scalpels, forceps, and other surgical tools that must remain sterile to prevent infections during procedures.</p>
</li>
<li>
<p><strong>Syringes and Catheters</strong>: These devices often have complex structures that require thorough sterilization to ensure patient safety.</p>
</li>
<li>
<p><strong>IV Sets and Plastic Tubing</strong>: Used in various medical treatments, these items are sensitive to heat and require a sterilization method that can penetrate their materials without causing damage.</p>
</li>
<li>
<p><strong>Pacemakers and Heart Valves</strong>: These critical devices must be sterilized without compromising their functionality or material integrity.</p>
</li>
<li>
<p><strong>Anesthesia Masks and Circuits</strong>: Essential for patient care during surgeries, these items must be free of any microbial contamination.</p>
</li>
<li>
<p><strong>Diagnostic Electrode Catheters</strong>: Used in various diagnostic procedures, these devices require precise sterilization to maintain their effectiveness.</p>
</li>
</ol>
<h3>Other Healthcare Products</h3>
<p>Beyond medical devices, ethylene oxide is also used to sterilize a variety of other healthcare-related products:</p>
<ul>
<li>
<p><strong>Gowns and Drapes</strong>: Used in surgical settings, these items must be sterile to maintain a clean environment.</p>
</li>
<li>
<p><strong>Wound Care Dressings</strong>: These products need to be free from microorganisms to prevent infections in open wounds.</p>
</li>
<li>
<p><strong>Synthetic Gowns and Procedure Kits</strong>: Often used in medical settings, these items require sterilization to ensure they do not introduce contaminants.</p>
</li>
</ul>
<h3>Industrial and Consumer Products</h3>
<p>Ethylene oxide is not limited to medical applications; it is also used in the sterilization of various industrial and consumer products:</p>
<ul>
<li><strong>Cosmetics</strong>: Certain cosmetic products are sterilized using EtO to ensure they are free from harmful microorganisms.</li>
<li><strong>Spices and Food Products</strong>: Some food items, such as spices and dried herbs, are sterilized with ethylene oxide to eliminate microbial contamination and extend shelf life.</li>
</ul>
<h3>Advantages of Ethylene Oxide Sterilization</h3>
<p>The use of ethylene oxide for sterilization offers several advantages:</p>
<ul>
<li>
<p><strong>Low-Temperature Process</strong>: EtO sterilization occurs at lower temperatures, making it suitable for heat-sensitive materials.</p>
</li>
<li>
<p><strong>Material Compatibility</strong>: It is compatible with a wide range of materials, including plastics, rubber, and other polymers, which might be damaged by other sterilization methods.</p>
</li>
<li>
<p><strong>Effective Penetration</strong>: Ethylene oxide gas can penetrate complex structures and packaging, ensuring thorough sterilization of all surfaces.</p>
</li>
</ul>
<h3>Safety and Regulatory Considerations</h3>
<p>While ethylene oxide is highly effective, it is also a toxic and flammable gas, necessitating strict safety protocols during its use. Regulatory bodies such as the FDA and international standards organizations have established guidelines to ensure the safe and effective use of EtO in sterilization processes. These regulations require manufacturers to validate their sterilization processes to achieve the necessary sterility assurance levels without compromising the safety or performance of the products.</p>
<h3>Conclusion</h3>
<p>Ethylene oxide plays a crucial role in the sterilization of a wide array of products, particularly in the medical field. Its ability to sterilize heat- and moisture-sensitive materials without damaging them makes it an invaluable tool in ensuring the safety and efficacy of medical devices and other products. Despite its effectiveness, the use of EtO requires careful handling and adherence to regulatory standards to mitigate its associated risks. As such, ethylene oxide remains a cornerstone of modern sterilization practices, safeguarding public health by preventing infections and ensuring the sterility of critical medical and consumer products.</p>
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What Is Sterilized With Ethylene Oxide

<p>Ethylene oxide (EtO) gas sterilization is a widely used method for sterilizing medical devices and other heat-sensitive materials. This process is particularly effective due to its ability to penetrate materials and kill a broad spectrum of microorganisms, including bacteria, viruses, fungi, and spores. Understanding how ethylene oxide gas sterilization works involves examining its chemical properties, mechanism of action, and the conditions under which it is most effective.</p>
<p>Ethylene oxide is a colorless gas at room temperature and is highly reactive due to its three-membered ring structure, which includes an oxygen atom. This reactivity is central to its ability to sterilize. The gas is capable of penetrating porous materials, which makes it ideal for sterilizing complex medical devices that cannot be exposed to high temperatures or moisture, such as those made of plastic or containing electronic components.</p>
<p>The mechanism by which ethylene oxide kills microorganisms is primarily through alkylation. Alkylation is a chemical reaction where an alkyl group is transferred to a molecule. In the case of ethylene oxide, it reacts with the nucleophilic sites in the DNA, RNA, and proteins of microorganisms. This reaction disrupts the normal functioning of these essential biomolecules. For DNA and RNA, alkylation can lead to mutations or prevent replication, effectively stopping the microorganism from reproducing. When proteins are alkylated, their structure and function are altered, which can inhibit vital cellular processes and lead to cell death.</p>
<p>The effectiveness of ethylene oxide sterilization depends on several factors, including concentration, temperature, humidity, and exposure time. Typically, the process is carried out in a sealed chamber where the concentration of ethylene oxide is carefully controlled. The temperature is usually maintained between 30&deg;C and 60&deg;C, as higher temperatures can enhance the reactivity of the gas and improve penetration. Humidity is another critical factor; a relative humidity of 40-80% is often required because moisture facilitates the penetration of ethylene oxide into the cells of microorganisms, enhancing its sterilizing action.</p>
<p>The exposure time can vary depending on the type and load of microorganisms present, as well as the nature of the materials being sterilized. Generally, the process can take several hours to ensure complete sterilization. After the sterilization cycle, it is crucial to aerate the materials to remove any residual ethylene oxide, as it is toxic and can pose health risks to humans.</p>
<p>Ethylene oxide sterilization is highly effective against a wide range of microorganisms, including resistant bacterial spores, which are often used as biological indicators to validate the sterilization process. However, the use of ethylene oxide is not without challenges. Its toxicity and potential carcinogenicity require strict safety measures to protect workers and the environment. Additionally, the process can be relatively slow compared to other sterilization methods, such as steam sterilization.</p>
<p>Despite these challenges, ethylene oxide remains a critical tool in the sterilization of medical devices and other sensitive materials. Its ability to penetrate complex structures and effectively kill a broad spectrum of microorganisms makes it indispensable in healthcare settings. Continuous advancements in technology and safety protocols aim to mitigate the risks associated with its use, ensuring that ethylene oxide sterilization remains a safe and effective method for ensuring the sterility of medical products.</p>

How Does Ethylene Oxide Gas Sterilization Kill Microorganisms?

<p>Ethylene Oxide (EtO) sterilization is a widely used method for sterilizing medical devices and other heat-sensitive materials. This process is particularly valuable because it allows for the sterilization of complex devices without compromising their functionality or integrity. One of the critical factors that influence the effectiveness of EtO sterilization is humidity. Understanding the role of humidity in this process is essential for ensuring optimal sterilization outcomes.</p>
<p><strong>Role of Humidity in EtO Sterilization</strong></p>
<p>Humidity plays a pivotal role in the EtO sterilization process by enhancing the penetration and efficacy of the ethylene oxide gas. The presence of moisture is crucial for several reasons:</p>
<ol start="1">
<li>
<p><strong>Hydration of Microorganisms</strong>: Humidity helps in hydrating the spores and bacteria, which reduces their resistance to the ethylene oxide gas. Microorganisms, particularly bacterial spores, are more susceptible to sterilization when they are hydrated. The water molecules facilitate the penetration of EtO into the cells, making it easier for the gas to disrupt cellular processes and inactivate the microorganisms.</p>
</li>
<li>
<p><strong>Gas Penetration</strong>: Adequate humidity levels are essential to facilitate the penetration of EtO gas into the materials being sterilized. The presence of moisture helps in carrying the gas to all reactive sites, ensuring that even the most intricate parts of complex medical instruments are thoroughly sterilized. This is particularly important for devices with porous or complex structures where microorganisms may hide.</p>
</li>
<li>
<p><strong>Enhancement of Sterilization Efficacy</strong>: Higher humidity levels can enhance the sterilization effectiveness by promoting the absorption and distribution of EtO gas throughout the materials. This ensures that the gas reaches all areas of the device, providing a more uniform and effective sterilization process.</p>
</li>
<li>
<p><strong>Temperature and Humidity Interplay</strong>: The interaction between temperature and humidity is also significant. As the temperature decreases, the solubility of EtO gas in the sterilization chamber increases, allowing more gas molecules to dissolve in the available space. This, coupled with higher relative humidity, creates an environment that is more conducive to EtO gas penetration and microbial inactivation.</p>
</li>
</ol>
<p><strong>Optimal Humidity Levels</strong></p>
<p>The optimal relative humidity (RH) for EtO sterilization typically ranges from 40% to 80%. Maintaining this level of humidity is crucial for achieving effective sterilization. If the humidity is too low, the sterilization process may be less effective, as the gas may not penetrate the materials adequately. Conversely, if the humidity is too high, it can lead to condensation, which may affect the integrity of the materials being sterilized.</p>
<p><strong>Preconditioning and Humidity Adjustment</strong></p>
<p>The EtO sterilization process involves several key steps, including preconditioning and humidity adjustment. During preconditioning, the packaged items are exposed to specific temperature and humidity conditions to make the microorganisms more susceptible to the gas. This step ensures that the sterilization process is more effective.</p>
<p>Once the items are loaded into the sterilization chamber, humidity is introduced to a specific level required to enhance the effectiveness of the ethylene oxide gas against microorganisms. This careful control of humidity is essential for ensuring that the sterilization process meets the required sterility assurance level (SAL).</p>
<p><strong>Challenges and Considerations</strong></p>
<p>While humidity is crucial for effective EtO sterilization, it also presents certain challenges. For instance, maintaining the optimal humidity level requires precise control and monitoring throughout the sterilization cycle. Additionally, the materials being sterilized must be able to withstand the humidity levels without compromising their integrity.</p>
<p>Moreover, the presence of humidity can lead to the absorption of EtO gas by certain materials, such as plastics and rubbers. This necessitates a thorough aeration phase to remove any residual gas and ensure the safety of the sterilized items.</p>
<p><strong>Conclusion</strong></p>
<p>In conclusion, humidity is a critical factor in the EtO sterilization process. It enhances the penetration and efficacy of the ethylene oxide gas, ensuring that even the most complex medical devices are thoroughly sterilized. By understanding and controlling humidity levels, healthcare facilities can optimize the sterilization process, ensuring the safety and effectiveness of medical devices. This underscores the importance of humidity in achieving successful EtO sterilization outcomes.</p>

The Importance Of Humidity When Using Eto Sterilization

<p>&nbsp;</p>
<h3>Testing and Validation of EtO</h3>
<ol start="1">
<li>
<p><strong>Process Validation:</strong></p>
<ul>
<li><strong>Biological Indicators (BIs):</strong>&nbsp;These are used to challenge the sterilization process. BIs contain a known quantity of highly resistant microorganisms, typically Bacillus atrophaeus or Geobacillus stearothermophilus. The sterilization process is considered effective if these microorganisms are inactivated.</li>
<li><strong>Chemical Indicators (CIs):</strong>&nbsp;These are used to visually confirm that the sterilization process has occurred. CIs change color when exposed to EtO under specific conditions, providing a quick visual check.</li>
</ul>
</li>
<li>
<p><strong>Physical Monitoring:</strong></p>
<ul>
<li><strong>Gas Concentration:</strong>&nbsp;The concentration of EtO gas in the sterilization chamber is monitored to ensure it remains within the specified range. This is crucial as the effectiveness of sterilization is directly related to the concentration of the gas.</li>
<li><strong>Temperature and Humidity:</strong>&nbsp;Both parameters are continuously monitored and controlled. The temperature typically ranges from 37&deg;C to 63&deg;C, and relative humidity is maintained between 40% and 80%.</li>
</ul>
</li>
<li>
<p><strong>Residual Testing:</strong></p>
<ul>
<li><strong>Ethylene Oxide Residuals:</strong>&nbsp;After sterilization, it is essential to test for residual EtO on the products. The ISO 10993-7 standard outlines acceptable limits for EtO and its by-products, such as ethylene chlorohydrin (ECH). Products must be tested to ensure these limits are not exceeded, ensuring safety for end-users.</li>
</ul>
</li>
<li>
<p><strong>Aeration:</strong></p>
<ul>
<li><strong>Degassing:</strong>&nbsp;This is a critical phase where the sterilized items are aerated to remove any residual EtO. The duration of aeration can vary but often lasts from several hours to days, depending on the material and the amount of EtO absorbed.</li>
</ul>
</li>
<li>
<p><strong>Environmental and Safety Monitoring:</strong></p>
<ul>
<li><strong>Leak Detection:</strong>&nbsp;Regular checks for leaks in the sterilization equipment and ventilation systems are necessary to prevent EtO exposure to workers and the environment.</li>
<li><strong>Air Monitoring:</strong>&nbsp;Continuous monitoring of EtO levels in the workplace is essential to ensure they remain below occupational exposure limits.</li>
</ul>
</li>
</ol>
<h3>Regulatory Compliance</h3>
<p>Compliance</p>
<h3>Challenges and Considerations</h3>
<ul>
<li>
<p><strong>Material Compatibility:</strong>&nbsp;Not all materials are compatible with EtO sterilization. It is crucial to assess the compatibility of materials with EtO to prevent damage or degradation.</p>
</li>
<li>
<p><strong>Cycle Optimization:</strong>&nbsp;The sterilization cycle must be optimized to balance effectiveness with safety. This involves adjusting parameters like gas concentration and exposure time to achieve the desired sterility assurance level.</p>
</li>
<li>
<p><strong>Safety Concerns:</strong>&nbsp;Due to its toxic nature, handling EtO requires stringent safety measures. Facilities must be equipped with appropriate ventilation and safety protocols to protect workers.</p>
</li>
</ul>
<h3>Conclusion</h3>
<p>Testing and validating EtO gas sterilization is a complex but essential process in the production</p>

How To Test Eto Gas Sterilization

<h3>What Does Using Ethylene Oxide on Plastics and Delicate Instruments Accomplish: Disinfection or Sterilization?</h3>
<p>Ethylene oxide (EtO) is widely recognized as a low-temperature sterilant. This colorless gas, which is flammable and potentially explosive, becomes liquid at temperatures below 11&ordm;C. EtO serves as an effective sterilizing agent for heat- and moisture-sensitive materials commonly found in hospitals, industries, and laboratories. It is particularly noteworthy for its ability to destroy bacterial spores, which typically show little resistance to this agent.</p>
<p>One of the key advantages of using EtO is that it operates effectively at relatively low temperatures without damaging the materials it contacts. This makes it especially suitable for sterilizing delicate instruments and plastics. Additionally, EtO possesses high penetrating power, allowing it to permeate and sterilize large packages, bundles of cloth, and various types of plastics. Historically, there have been practices where operating rooms were filled with EtO after procedures to achieve sterilization.</p>
<p>The mechanism of action involves alkylation reactions with organic compounds, such as enzymes, leading to the inactivation of critical proteins, including those containing sulfhydryl groups.</p>
<p>Common applications for EtO include sterilizing spices, biological preparations, soil, plastics, certain medical supplies, and contaminated laboratory equipment.</p>
<p>However, there are notable drawbacks to using EtO. Its action on microorganisms can be relatively slow, and the removal process via aeration may take up to 12 hours. Additionally, it is expensive, forms explosive mixtures with air, and is flammable. Importantly, EtO is classified as a known human carcinogen.</p>
<p>In summary, employing ethylene oxide on plastics and delicate instruments primarily accomplishes sterilization rather than mere disinfection, making it a potent tool in maintaining hygiene standards in sensitive environments.</p>

What Does Using Ethylene Oxide On Plastics And Delicate Instruments Accomplish: Disinfection Or Sterilization

<h1>How is Gamma Sterilization Performed?</h1>
<p>Gamma irradiation sterilization involves exposing products to a radiation source, typically the Cobalt-60 isotope. As Cobalt-60 decays, it transforms into Nickel-60 while emitting gamma rays in the process. These gamma rays interact with the molecules within the object, causing ionization of the chemical bonds. This interaction alters the molecular structure of the material, often rendering it unrecognizable and incapable of supporting microbial life.</p>
<p>This method of sterilization offers several advantages over other forms of sterilization, such as ethylene oxide (EtO), boiling, or chemical treatments. However, it is not without its limitations. One notable characteristic of gamma irradiation is that it is considered a "cold process," as the temperature of the processed product does not significantly increase during treatment. Additionally, this procedure requires no chemicals and operates independently of pressure, temperature, or humidity, making it a versatile option for sterilization.</p>
<p>In summary, gamma sterilization is a highly effective method that utilizes radiation to achieve thorough disinfection, while maintaining the integrity of heat-sensitive materials.</p>

How Is Gamma Sterilization Performed

<h1>Requirements for <a href="https://www.hzbocon.com/product-list/ethylene-oxide-sterilizer">EO Sterilization</a></h1>
<p>Effective sterilization necessitates meticulous attention to the six key conditions required for the successful use of ethylene oxide (EO).</p>
<ol>
<li>
<p><strong>Unobstructed Path for Gas Penetration:</strong> Although ethylene oxide is highly penetrative, it requires a clear pathway to effectively sterilize the interiors of devices. Complex instruments should be disassembled before sterilization to allow the gas to reach even the most remote recesses. Components such as caps, plugs, or styles must be removed prior to the sterilization process.</p>
</li>
<li>
<p><strong>Removal of Biological Residues:</strong> Organic matter left on instruments can shield microorganisms from EO's lethal effects. It is essential to thoroughly wash and dry instruments intended for gas sterilization to ensure they meet the standards of surgical cleanliness.</p>
</li>
<li>
<p><strong>Appropriate Wrapping Materials:</strong> Utilize suitable wrapping materials for gas sterilization, such as paper, cloth, or EO-permeable plastic. These materials permit the diffusion of ethylene oxide into the package, ensuring effective sterilization of the contents. For instruments that will be used in an operating room, double-wrapping may be employed, following traditional sterilization methods. Note that paper and cloth wrapping materials are not impervious to microorganisms and generally require reprocessing at specified intervals.</p>
</li>
<li>
<p><strong>Sufficient Dosage of Ethylene Oxide:</strong> An adequate dose of ethylene oxide must be applied for a sufficient duration to effectively eliminate even the most resistant microorganisms.</p>
</li>
<li>
<p><strong>Adequate Humidity:</strong> The presence of appropriate humidity is crucial for facilitating the sterilization process. Desiccated organisms may exhibit increased resistance to ethylene oxide sterilization.</p>
</li>
<li>
<p><strong>Temperature Considerations:</strong> The required dose of ethylene oxide is influenced by the temperature of the sterilization process. Generally, higher temperatures necessitate lower doses of EO to achieve effective sterilization.</p>
</li>
</ol>
<p>By adhering to these essential requirements, you can ensure optimal effectiveness in<a href="https://www.hzbocon.com/products/industry-eto-sterilizer"> EO sterilization</a> processes.</p>

Requirements For EO Sterilization

<h1>ETO Sterilizer</h1>
<h2>Introduction</h2>
<p>Ethylene oxide sterilization, commonly known as EO or ETO sterilization, is a chemical process that disrupts the genetic structure of bacteria, effectively preventing their proliferation. This method utilizes specific essential ingredients and alkylation properties to achieve its disinfecting capabilities. Given that certain microorganisms can resist high-temperature steam disinfection and continue to replicate, we are pleased to offer a wide range of sterilizers designed for the pharmaceutical and medical industries at hzbocon Our low-temperature ETO sterilizers meet industry standards and comply with both national and international guidelines.</p>
<p>ETO sterilizers are widely employed in the pharmaceutical and medical sectors to disinfect various medical supplies and equipment. Their efficacy in eliminating germs, viruses, fungi, and spores makes them suitable for use on materials such as plastics, electronics, and intricate surgical instruments that may be sensitive to heat or moisture. The sterilization process takes place in a controlled environment where temperature, humidity, and gas concentration are meticulously regulated. Ethylene oxide gas permeates the materials, targeting and destroying the DNA and RNA of harmful microorganisms, ensuring thorough sterilization.</p>
<h2>Advantages of ETO Sterilizers</h2>
<ul>
<li><strong>Effective Sterilization:</strong>&nbsp;ETO sterilizers provide a high level of microbial kill rate, making them reliable for critical applications.</li>
<li><strong>Low-Temperature Sterilization:</strong>&nbsp;They operate at low temperatures, making them ideal for heat-sensitive items.</li>
<li><strong>Versatility:</strong>&nbsp;Suitable for a variety of materials, including those that cannot withstand traditional sterilization methods.</li>
<li><strong>Validation:</strong>&nbsp;Established protocols ensure consistent and reproducible results.</li>
</ul>
<p>ETO sterilizers are crucial for maintaining the sterility and safety of medical supplies and equipment. While the industry continues to explore safer and more sustainable alternatives, ETO sterilization remains vital due to its proven effectiveness and adaptability. When operated according to safety standards and proper management practices, ETO sterilization is a safe and reliable process for healthcare and related industries.</p>
<p>The ethylene oxide (ETO) sterilizer machines offered by us are designed to eliminate microscopic germ particles that are invisible to the naked eye but pose significant risks to both human health and the environment. Medical items such as syringes, latex gloves, catheters, and other sensitive products undergo this rigorous sterilization process. We pride ourselves on providing the best prices available in the market for these essential sterilization solutions.</p>

ETO Sterilizer Information

<h1 id="sterilizationmethodforsyringefilter">Sterilization Method for Syringe Filter</h1>
<h2 id="introduction">Introduction</h2>
<p>Sterile syringe filters are crucial in various industries such as pharmaceuticals, fermentation, food &amp; beverage, beer brewing, and biological products. The process of sterilizing these filters is essential to ensure the safety and effectiveness of the products they are used with. Two commonly used methods for sterilizing syringe filters are ETO sterilization and Gamma sterilization.</p>
<h3 id="etosterilization">ETO Sterilization</h3>
<p>ETO sterilization, also known as ethylene oxide sterilization, works by destroying the metabolism of bacteria and causing microbial death. However, it is important to note that ethylene oxide gas is toxic, so the concentration of EO in the indoor air must be controlled below national standards. The sterilization process using EO can be lengthy due to the necessary ventilation to remove EO residues. Additionally, as EO gas is flammable and explosive, safe sterilizers must be selected to ensure safe storage and operation.</p>
<h3 id="gammasterilization">Gamma Sterilization</h3>
<p>Gamma sterilization involves the use of gamma-ray irradiation to alter the chemical substances&nbsp;<span class="katex"><span class="katex-mathml">DNA</span><span class="katex-html" aria-hidden="true"><span class="base"><span class="mord mathdefault">D</span><span class="mord mathdefault">N</span><span class="mord mathdefault">A</span></span></span></span>&nbsp;in microorganisms, leading to the loss of cell activity and ultimately achieving sterilization. This method offers advantages such as complete sterilization, non-toxicity, no residue, environmental friendliness, low energy consumption, and immediate usability post-sterilization. However, equipment for gamma-ray sterilization requires a significant initial investment. Additionally, post-sterilization, the white syringe filter may appear slightly yellowish.</p>
<p>In conclusion, both ETO and Gamma sterilization methods have their pros and cons, and the choice of sterilization method depends on various factors such as the industry requirements, safety considerations, and the scale of production. Proper sterilization of syringe filters is crucial in ensuring the quality and safety of products in various industries.</p>

Sterilization Method For Syringe Filter

<p>&nbsp;</p>
<h2><strong>DANGER! ETHYLENE OXIDE: CANCER AND REPRODUCTIVE HAZARD</strong></h2>
<ol>
<li>Ensure that the sterilizer ventilation system is operational before starting and during operation.</li>
<li>Use in-chamber aeration whenever possible.</li>
<li>When transferring a sterilizer load to an aerator, follow these precautions:</li>
</ol>
<ul>
<li>After completing the required purge/aeration cycles, leave the load in the sterilizer for additional cycles as time permits.</li>
<li>Verify the functionality of local exhaust ventilation above the sterilizer door.</li>
<li>Open the sterilizer door to the notched position&nbsp;<span class="katex"><span class="katex-mathml">𝑜𝑟2𝑖𝑛𝑐ℎ𝑒𝑠𝑖𝑓𝑛𝑜𝑛𝑜𝑡𝑐ℎ𝑒𝑑𝑝𝑜𝑠𝑖𝑡𝑖𝑜𝑛𝑖𝑠𝑎𝑣𝑎𝑖𝑙𝑎𝑏𝑙𝑒</span><span class="katex-html" aria-hidden="true"><span class="base"><span class="mord mathdefault">o</span><span class="mord mathdefault">r</span><span class="mord">2</span><span class="mord mathdefault">i</span><span class="mord mathdefault">n</span><span class="mord mathdefault">c</span><span class="mord mathdefault">h</span><span class="mord mathdefault">e</span><span class="mord mathdefault">s</span><span class="mord mathdefault">i</span><span class="mord mathdefault">f</span><span class="mord mathdefault">n</span><span class="mord mathdefault">o</span><span class="mord mathdefault">n</span><span class="mord mathdefault">o</span><span class="mord mathdefault">t</span><span class="mord mathdefault">c</span><span class="mord mathdefault">h</span><span class="mord mathdefault">e</span><span class="mord mathdefault">d</span><span class="mord mathdefault">p</span><span class="mord mathdefault">o</span><span class="mord mathdefault">s</span><span class="mord mathdefault">i</span><span class="mord mathdefault">t</span><span class="mord mathdefault">i</span><span class="mord mathdefault">o</span><span class="mord mathdefault">n</span><span class="mord mathdefault">i</span><span class="mord mathdefault">s</span><span class="mord mathdefault">a</span><span class="mord mathdefault">v</span><span class="mord mathdefault">a</span><span class="mord mathdefault">i</span><span class="mord mathdefault">l</span><span class="mord mathdefault">a</span><span class="mord mathdefault">b</span><span class="mord mathdefault">l</span><span class="mord mathdefault">e</span></span></span></span>&nbsp;and vacate the area for 15 minutes.</li>
<li>Transfer the load swiftly and maintain a distance from the face.</li>
</ul>
<ol>
<li>In the event of an ethylene oxide leak or emergency, evacuate the area immediately and implement the emergency response plan. DO NOT RE-ENTER WITHOUT A SUPPLIED-AIR RESPIRATOR.</li>
</ol>
<h2><strong>Work Practice Guidelines for Ethylene Oxide Sterilizers: Posted Near Ethylene Oxide Supply Cylinders</strong></h2>
<ol>
<li>Before replacing cylinders, ensure local exhaust ventilation for the cylinder is operational.</li>
<li>When changing cylinders, wear a full faceshield, protective gloves, and other required protective clothing as per OSHA&nbsp;<span class="katex"><span class="katex-mathml">29𝐶𝐹𝑅1910.1047</span><span class="katex-html" aria-hidden="true"><span class="base"><span class="mord">2</span><span class="mord">9</span><span class="mord mathdefault">C</span><span class="mord mathdefault">F</span><span class="mord mathdefault">R</span><span class="mord">1</span><span class="mord">9</span><span class="mord">1</span><span class="mord">0</span><span class="mord">.</span><span class="mord">1</span><span class="mord">0</span><span class="mord">4</span><span class="mord">7</span></span></span></span>&nbsp;regulations.</li>
<li>Prior to disconnecting the supply line from the cylinder valve, release excess pressure by venting the supply line into the ventilation system.</li>
<li>In the event of an ethylene oxide leak or emergency, evacuate the area immediately and follow the emergency response plan. DO NOT RE-ENTER WITHOUT A SUPPLIED-AIR RESPIRATOR.</li>
</ol>
<h2><strong>Work Practice Guidelines for Ethylene Oxide Sterilizers: Posted at Mechanical Access Room Entrances</strong></h2>
<p><strong>CAUTION!</strong>&nbsp;This room may contain high concentrations of ethylene oxide.</p>
<ol>
<li>In the event of an ethylene oxide leak or emergency, evacuate the area immediately and initiate the emergency response plan. DO NOT RE-ENTER WITHOUT A SUPPLIED-AIR RESPIRATOR.</li>
</ol>

Work Practice Guidelines For Ethylene Oxide Sterilizers

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