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END ETO C 1445
Industrial Type Ethylene Oxide SUTURE Sterilization Device


Industrial ETO C1445 Ethylene Oxide Suture Sterilization Device

ISO 9001 ISO 13485 CE 1984

IND ETO C1445 Industrial Ethylene Oxide Sterilizer Data Sheet  EN - Pdf 529 Kb.

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The world's most advanced ethylene oxide suture sterilization device manufacturer:

TEKNOMAR

For professionals 0,5 - 1 - 1,6 - 2,1... m3 and more.

EO C-1445
Industrial Ethylene Oxide Suture Sterilization Device

For all kinds of Medical Materials, Absorbable and Non-Absorbable

SUTURE Ethylene Oxide Sterilization Devices with Under Vacuum Working Principle


IND EO C1445 Industrial Type Suture Sterilizer

Industrial Type EO Suture Sterilizer ETO-C 1445 is the best solution partner for suture and medical equipment manufacturers. Most products that are sensitive to heat and humidity can be sterilized with Ethylene Oxide gas sterilization. ETO-C 1445 will be the most important building block of your production line with different M3 options.

Teknomar Ltd follows a customer-oriented approach to be the best solution partner.

Sterilization should be considered the first and most important stage of production.

Teknomar Ltd has undertaken professional projects with its experienced engineers and technicians. Standard and Special Production devices are manufactured from the highest quality stainless steel.

Teknomar Ltd has strong experience in the sterilization of disposable medical products, absorbable and non-absorbable sutures, catheters, laparoscopic surgical instruments, implants, sensitive flexible medical products, endosppositories, rigid and semi-rigid lumen-shaped instruments.

Main Features of Suture Ethylene Oxide Sterilization and Drying Device
Suture Sterilization Shelf Cabinet Structure Suture Sterilization Full Load
  • Working Temperature between 37 - 55 ºC
  • Negative Pressure, vacuum working method 10-1 Torr
  • In a Single Boiler; Preconditioning, Sterilization, Degassing (Aeration)
  • Suture Drying / Dehumidification, Drying with Nitrogen or Inert Gases, Dehumidification Feature
  • 6-8 Hours Ethylene Oxide Gas Exposure Time
  • Sterilization of Products Sensitive to Humidity and Heat
  • Single or Double Door Selection
  • Flameproof High Technology Electronic Parts
  • All Stainless Steel Boiler and Parts (316L / 304)
  • Easy Loading and Unloading Suture Rack Tray System
  • Complete Dissolution of EO Gas with Advanced Neutralization Technique - Water Scrubber Method.
  • Compatibility with Acidic and Combustion Neutralization Systems
  • SCADA Process Control
  • High-tech sensor systems
  • PLC Process Control
  • Compatibility with EN 1422 - ISO 11135 standards
  • CE marked
  • Compatibility with ISO 14937 Validation Standards
  • Reporting and Graphic Output Suitable for Validation
  • Validation and Calibration for Sutures
  • IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) validation
  • Detailed Reporting Function
  • Easy to Use with Colorful, Wide Touch Screen Panel
  • Kiosk control unit
  • Compatible with Different EO Gas Mixtures
  • Safe, Accurate and Durable Sterilization Solution
  • User Safety Features
Gas Mixtures
ETO C 1445 Industrial Ethylene Oxide Gas Cylinder

Different Gas Mixtures Can Be Selected According to the Material Validation. Some of them;

  • % 10 EO - % 90 CO2
  • % 50 EO - % 50 CO2
  • % 90 EO - % 10 CO2
  • % 100 EO
TEKNOMAR Ethylene Oxide Sterilization Device CHAMBER DIMENSIONS
Industrial Type EO Sterilization Device
C-1445 		Ethylne Oxide Sterilization Device
Chamber Inner Dimensions
Weight
(~kg)
Power
(kW)
Chamber Volume
(~m3)		Euro PalletDoorWidth
(cm)		Depth
(cm)		Height
(cm)
0,5 Suture - Single 82,5 74 82,5 960 10 kW
1 - Single 90 110 100 1450 21 kW
1,6 Suture - Single/Double 90 158 113 2000 25 kW
2,1 Suture - Single/Double 90 160 140 2500 30 kW

* The above dimensions show the standard production. The custom sized manufacturing is available, Please contact to your representative for more information.

* Pallet size: EURO 80 X 120 cm

ETO C1445 Suture Sterilization device has a compact one-piece built-in design for the user to use for multifunctional purposes. The device allows the user to program different parameters for multiple suture sterilization.

In today's low-tech devices, users have to use separate devices for preconditioning, dehumidification and drying of products (Bagged and Ampoule Breaking, Old Technology under Vacuum). This increases the workload of employees, sterilization time and sterilization cost.

ETO C1445 offers a new technique in suture sterilization where preconditioning, sterilization, ventilation, dehumidification and drying processes are performed by only one device.

Once the ETO C1445 suture sterilization processes are completed, the sterile packaged products can be used immediately without the need for additional ventilation, as there is no EO gas residue on the products.

ETO C1445 suture sterilization reduces all possible costs to provide you with optimized economies of scale. Teknomar Ltd. offers verification and calibration services for different materials. The average sterilization time is 6-8 hours excluding drying processes, although this time can be lower or higher depending on the material to be sterilized. FAT (Factory Acceptance Test). Teknomar Ltd. assigns its best programmers and technicians to set the device to the most suitable sterilization level, considering the sterilization cycle costs and sterilization accuracy.

Industrial Ethylene Oxide Suture Sterilization Device Working Process and Reporting
Teknomar Industrial Ethylene Oxide Sterilization Device, EO Gas Sterilizer, Autoclave Working Diagram
Teknomar Industrial Ethylene Oxide Suture Sterilization Device Working Diagram
Teknomar Industrial Ethylene Oxide Sterilization Device Kiosk Management Panel
Device Kiosk Management Panel
  • Vacuum 1: Before starting the device sterilization process, a preliminary leakage test is performed under vacuum.
  • Leakage 1 Period: After the first vacuum process, there is a leak test waiting period. At the end of this period, the vacuum level in the tank will be measured and it will be checked whether there is a change in the pressure/vacuum value and whether there is any leakage or leakage. In case of leakage or leakage, the device will not start the sterilization process. It will give a leakage warning. If the leakage test is passed successfully, the EO sterilization process will start.
  • Humidity / Preconditioning: After the leak test is successfully completed, the device is preconditioned by moisture removal.
IND EO Device Vacuum Operation Chart
EO Sterilization Reporting in Accordance with MDR
  • Vacuum 2 Period: After the preconditioning is completed, the device performs the bottom vacuum process. Secondary sub-vacuum conditioning continues.
  • Leak Test 2: After the device has completed the bottom vacuum and conditioning process, it performs a second leak test for high security. During this period, it waits without doing any operation and at the end of this period, the sterilization process begins with gas extraction.
  • Gas Intake: The sterilization phase begins with EO gas inlet. This process continues until the device reaches a safe vacuum value. The sterilization process begins.
  • Sterilization Period: The sterilization period is the most important and longest part of the system. The products in the device are exposed to gas during this period. The sterilization process is carried out during this process.
  • Exhaust Vacuum: After the sterilization period is completed, the EO gas in the device is evacuated by vacuuming. The gas is neutralized and exhausted with the aqueous neutralization system. When the bottom vacuum value of the sterilization chamber is reached, the dilution period begins.
  • Rest: After the gas in the device is evacuated, the sterilized products are subjected to dilution. After the dilution waiting period, the sterile air washing process begins.
  • Clean Air Washing: After the waiting period for the cleaning of EO gas inside the device, air washing is performed to ensure that there is no residue on the sterilized material. At the end of the air washing process, atmospheric pressure is reached and the covers are allowed to be opened. There are at least 3 air washing programs as fixed values in the sterilization operation program for the air washing process. Apart from this, the user is offered the opportunity to enter a value between 1-99 for the number of air washing.
  • Entering the Number of Washing with Inert Gases for Dehumidification: Suture packages are subjected to a washing process with nitrogen or other inert gases to dehumidify the suture. Here, the desired moisture value (rH) in the sutures is between 4-20 ppm or 20-100 ppm. Inert gas cylinders are used for these values. The manufacturer performs PQ for the desired moisture value and determines the number of washing with inert gases. The device has the technology to provide these values. The user is offered the opportunity to enter a value between 1-99 for the number of dehumidification with inert gases.
  • Temperature: The device can be set at the desired temperature between 37 C - 55 C degrees. The device keeps the temperature constant at the set value during operation, sterilization and dehumidification with inert gases.
Ethylene Oxide Device Boiler Production Stage
62.5 m3 Industrial Ethylene Oxide Device Production AreaTeknomar Industrial Ethylene Oxide Autoclave Production AreaIndustrial Ethylene Oxide Device Production Area
Ethylene Oxide Sterilization Device Production Area
Some Well-Known Machine Manufacturers Cooperated with Teknomar Ltd in the Production of Industrial Ethylene Oxide Suture Sterilization Devices
Teknomar ETO C1445 Cihazında Kullanılan Bazı Malzemeler

Siemens, Festo, ABB, AdvanTech, Oksitem, Yeni Kromsan, Schneider, Phoenix, Reliance

Maintenance

ETO C1445 maintenance is simple and easy and does not require professionalism. Daily and routine maintenance can be easily done by trained users.

Teknomar Ltd provides design, manufacturing, assembly, training, service, validation and related services to its customers.


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