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END ETO C 1445 Sterilization Devices

END ETO C 1445 Sterilization Devices
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END ETO C 1445 Sterilization Devices

Product catalog summary
Introduction
TEKNOMAR GROUP, established in 1993, is renowned for its high-tech sterilization devices, particularly in Ethylene Oxide (EO) sterilization. Their ETO C 1445 model is the largest industrial EO sterilizer globally, with a capacity of 62.5 m³.
Specifications
The ETO C 1445 operates at low temperatures (37-55°C) using a vacuum method. It features a single chamber for preconditioning, gassing, and aeration, reducing equipment needs and costs. Equipped with SCADA software, it offers detailed process control and reporting, complying with EN 1422, EN ISO 11135, and EN ISO 14937 standards.
Operational Features
The device supports various EO gas mixtures and operates under vacuum for safety and efficiency. It includes a comprehensive sterilization cycle with stages like preconditioning, sterilization, and air washing, all in one chamber. Automatic management of pressure, gas, and humidity is included.
Advantages
The ETO C 1445 reduces sterilization time and cost, enhances safety, and can sterilize a wide range of materials, including temperature-sensitive and long lumen products. It features a halogen-free electrical system and is designed for easy loading and unloading.
Water and Gas Consumption
The device uses water for steam and neutralization, with consumption rates varying by cycle. EO gas consumption depends on the gas mixture, with detailed rates for different EO and CO2 ratios.
Layout and Installation
Installation requires specific layout and space, with configurations for single and double-door options. Electrical supply, pressure air, clean water, drainage, EO gas supply, and exhaust connections are necessary.
Neutralization System
The device includes a water and acidic scrubber system for EO gas neutralization, integrated with SCADA software and controlled by a SIEMENS PLC unit, ensuring environmental safety.
Validation Process
Validation includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring compliance with ISO 11135 and EN 1422 standards, verifying the sterilization process against the Sterility Assurance Level (SAL) 10-6.
Sterilization Cycle
The document details the EO sterilization cycle, including preconditioning, gas leak tests, conditioning, EO gas intake, exposure, aeration, and release, with specific parameters for temperature, pressure, and humidity.
Performance Qualification
PQ validation is conducted using cycles such as Empty, Quarter, Half, and Full Cycles to ensure sterilization effectiveness and safety.
Sterilization Process Overview
The document outlines the EO sterilization process for various products, emphasizing full cycle sterilization for safety, especially for difficult products.
Device Capacity and Selection
Guidance is provided on selecting device capacity based on production needs, with a calculation method for determining required capacity in cubic meters or Euro pallets.
Device Specifications
The ETO C 1445 is an industrial EO sterilizer with capacities from 1m³ to 120m³, offering design flexibility to meet customer needs.
Company Information
Teknomar Group, based in Ankara, Turkey, provides design, manufacturing, assembly, training, technical service, and validation, ensuring devices are easy to maintain and technologically advanced.
Contact Information
Contact details for Teknomar Group are provided for further inquiries or support.
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Catalog excerpts

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INDUSTRIAL ETHYLENE OXIDE HIGH TECHNOLOGY STERILIZATION DEVICE Wherever you need sterilization Biggest In The World! With 62,5 m3 Preconditioning, Gassing, Aeration In One Chamber 1

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uiffi Croup Since 1993, TEKNOMAR GROUP has been producing high-tech devices with the TEKNOMAR Brand in 8 different product groups and many sectors. It produces; broke new ground in the world with its R&D studies on Surgical Instrument Sterilization Devices (Industrial Ethylene Oxide, Hospital Type Ethylene Oxide, Hydrogen Peroxide Plasma, Heavy Molecule Sterilization Devices) and Air Cleaning and Conditioning Systems. In addition, it has become a pioneer to the world in technology by developing the HdrOzone Hydronium Heavy Molecule new generation sterilization technique.

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Teknomar has produced world’s largest Industrial Type Of Ethylene Oxide Sterilization Device which is 62.5 m³. Ethylene Oxide Sterilization Devices that Working Under Vacuum For All kinds of Medical Equipment, Absorbable and Non-Absorbable Sutures, Medical Textile Products etc. 3

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TEKNOMAR ETHYLENE OXIDE DEVICE PRODUCTION AREA Teknomar is a strong market player that has become a global brand in the production of low temperature (37- 55oC) Ethylene Oxide, Hydrogen Peroxide, hdrOzone Heavy Molecule sterilization devices. Since 1993, serial and special Industrial Ethylene Oxide Sterilization Devices have been produced in Teknomar Group’s high-tech, modern 4000 m2 production facilities. Teknomar offers economical solutions in the field of EO sterilization devices by employing the best engineers, software developers and technicians in the production of ETO C 1445 Industrial...

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Active, Fast, Dry System High-Tech Industrial Ethylene Oxide Low Temperature Sterilizer ETO C 1445 Ethylene Oxide Sterilization Device; Ethylene oxide gas expelled by the water neutralization it is a device that can sterilize all kinds of disposable and system is dissolved and converted into ethyl glycol, re-sterilisable medical instruments, lumen materials degassed air is given to nature. (without diameter and length limit), plastic, inorganic, electro-mechanical, temperature and humidity sensitive The device automatically detects the pressure, gas, equipment and material with ethylene oxide...

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ETO C 1445 INDUSTRIAL ETHYLENE OXIDE STERILIZER MAIN SPECIFICATIONS & ADVANTAGES * Preconditioning, Sterilization, Aeration in One Chamber Negative Pressure, Under Vacuum Sterilization Method (10-1 Torr) Operation at Desired Temperature Between 37 - 55 ºC Reliable Sterilization of Humidity and Temperature Sensitive Long Lumen Products One Cycle Sterilization Cycle Time Including All Stages 6-8 hours IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) Validation Halogen Free Electrical and Electronic Hardware SCADA Software and Process Control

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Easy Loading with Pallet and Unloading Roller Systems Loading and Sterilization Feature of the Materials to be Sterilized with Parcels /Pallet Complete Dissolution of EO Gas by Enhanced Neutralization Technique – Water Scrubber Method Compatibility to Connect to Acidic and Catalytic Neutralization System (Optional) High-Tech Sensor Systems Suitable for MDD and MDR PLC Industrial Electronics and Process Control Compliance with EN 1422 - EN ISO 11135 Standards Compliance with EN ISO 14937 Validation Standards Validation and Calibration for Different Products EN ISO 14937 Reporting and Graphical...

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SUTURE EO sterilization and drying device system is a special production and includes standard EO device features. Unlike the EO process, it is used for suture sterilization. In addition, moisture drying is done between 0-10 ppm under N2, CO2 or inert gases for suture sterilization. Suture process, packaging and sealing are done with trays in small batches. Main Specifications; ■ Operating under nitrogen ■ Moisture-Free Operating Sterilization Feature ■ Shelf System / Tray System ■ Deep Vacuum Operating Value 950 mbar ■ Operating with Oil Vacuum Pump ■ Different Capacity Production for Suture...

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Correct and Complete Necessary Conditions for EO Sterilization TEMPERATURE: Ethylene Oxide Device should be operated between 37OC and 55OC for full efficiency in sterilization. MOISTURE: Humidity is needed in the sterilization process with ethylene oxide gas. Sterilization cannot be completed without sufficient moisture content. Humidity is required to open the pores of the packaging roll papers (Tyvek etc.) used in sterilization and to allow the diffusion of EO gas to the material to be sterilized. In addition, moisture is needed to revive microorganisms in the GAS: The gas to be used in the...

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ETO C 1445 INDUSTRIAL ETHYLENE OXIDE STERILIZATION DEVICE UNDER VACUUM OPERATING PROCESS Sterilization Process Teknomar Industrial Ethylene Oxide Sterilizer Operation Diagram ■ Vacuum 1: Before the device starts the sterilization process, the 1st and 2nd leak tests are performed under vacuum for safety control. ■ Leakage 1 Period: Leakage 1 Period: After the first vacuum operation, there is a leak test waiting period. At the end of this period, the vacuum level in the chamber is measured and checked whether there is a change in the pressure/vacuum value, leak. In case of leakage, the device does...

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■ Gas Intake: The sterilization phase starts with the inlet of EO gas. EO gas is taken until this process reaches the safe vacuum value in the device. The sterilization process begins. In the sterilization stage, the products are exposed to Ethylene Oxide (EO) gas to eliminate the microorganism at a certain time and under vacuum. ■ Sterilization Period: Sterilization time is the most important and longest part of the system. The products in the device are exposed to gas during this period. In this process, the sterilization process is carried out. ■ Exhaust Vacuum: After the sterilization period...

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Industrial Ethylene Oxide Sterilization Device Sterilization Unit Layout Plan NON STERILE PRODUCT AREA

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Sterilization should be considered as the first and most important stage of production. STERILE PRODUCT AREA

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