Adinath, Ethylene Oxide Sterilizer, 15 CBM

Description

  1. Overview
    1. Ethylene oxide (ETO) sterilization is mainly used to sterilize medical and pharmaceutical products that cannot support conventional high temperature steam sterilization – such as devices that incorporate electronic components, plastic packaging, or plastic containers.
    2. ETO gas infiltrates packages as well as products themselves to kill microorganisms that are left during production or packaging process.
    3. This gas, mixed with air at a ratio of at least 3% ETO gas, forms an explosive mixture.
    4. Pure ETO gas boiling point is 10.73°C at atmospheric pressure.
    5. Most of the time, it is mixed with nitrogen or CO2.
    6. This explosive condition requires intrinsic safe material (ATEX) zoning, for security of people as well as security of the process itself.
    7. Safety of personnel is an important issue due to the harmful effect of ETO on humans.
    8. Polluted areas need to be alarmed using gas detectors set up at different locations to monitor any leak.
    9. Visual and audio alarm systems need to be provided.
    10. The system must inform any operator when a sterilization cell contains ETO.
    11. When this toxic gas is removed from the room it needs to be treated using thermal burners, scrubbers or oxidation for environmental protection or be transported to an alternate facility for treatment.
  2. Process
    1. ETO sterilizer offers various distinct advantages over the conventional steam sterilizers, being a dry and cold (operates at 50°C) process proves very useful in sterilization of expensive items.
    2. It has got a unique penetration ability, so it is very useful in sterilization of expensive and delicate items such as cardiac catheters, stents, IOL’s tubing, various types of scopes, sharp surgical instruments, etc.
    3. Its unique mode of action also enhances the life of several surgical accessories and disposable items, thus making them perfectly reusable.
  3. Mode Of Operation
    1. ETO sterilization can be carried out by using gas mixture containing ethylene oxide + carbon dioxide, which is normally available in cylinders.
    2. Below mentioned concentrations are suitable in the equipment: 10% ETO and 90% CO2, or 20% ETO and 80% CO2.
  4. Technical Specifications
    1. Chamber
      1. Internal chamber size: 1220mm x 2000mm x 6300mm (W x H x L)
      2. Overall size: 1500mm x 2600mm x 7000mm (W x H x L)
      3. Internal material of construction: 10mm thick stainless steel #304
      4. Internal finish: Mirror finish
      5. Operating pressure: -20” inch/Hg to 10 psi
      6. Test pressure: 20 psi
      7. Gas options: 10% ETO and 90% CO2, or 20% ETO and 80% CO2
      8. Sterilizer chamber connection ports:
        1. Vacuum port: 50mm round shaft, SS #304
        2. Gas-in port: 38mm round shaft, SS #304
        3. Exhaust port: 50mm round shaft, SS #304
        4. RH inlet port: 32mm round shaft, SS #304
        5. Air inlet port: 32mm round shaft, SS #304
        6. Validation port: 32mm round shaft, SS #304
        7. Sensor port: 32mm/38mm round shaft, SS #304
      9. Chamber comes with all necessary connections to perform the sterilization process.
      10. All piping and connections to the chamber are made from SS #304.
      11. One digital temperature controller to control the chamber temperature and one pressure/vacuum gauge to read the chamber pressure also provided.
      12. One safety valve made from SS #304 is also provided.
    2. Water Jacket
      1. Purpose of jacket: Water circulation
      2. Material of construction: Mild steel
      3. Plate thickness: 8mm mild steel plate
      4. Test pressure: 0.5 kg/cm²
      5. Connections: Water in port = 25mm mild steel; water out port = 25mm mild steel
      6. Outer cover: Company’s hair finish sheet
      7. Insulation: 30mm thick resin-bonded fiber glass wool, insulation is provided with S.S. (18SWG) outer covering
    3. Door
      1. Number of doors: Double
      2. Type of door: Hinged type door with bolt and nut type locking
      3. Material of construction (door): 16mm thick stainless steel 304
      4. Gasket: Solid section silicon gasket
      5. Door hinge: 20mm thick mild steel plate
      6. Finish of door hinge: Auto-paint
      7. Stand: Made from MS C-section channel
  5. Accessories / Utilities
    1. Hot Water Tank
      1. Capacity: 400 liters
      2. Material: SS #304
      3. Thickness: 2mm
      4. Heaters: 6 water immersion heaters, 36 kW (6 kW each) with magnetic float switch for protection
      5. Gas vaporization system: One stainless steel coil is provided in the hot water tank to pre-heat the gas before entering the chamber
    2. Gas Dilution Tank
      1. Capacity: 200 liters
      2. Material of construction: SS #304
      3. Equipped with all of the necessary nozzles and connections
    3. Vacuum Pump
      1. 7.5 HP / 3 phase
    4. Water Circulation Pump
      1. 1 HP / 3 phase with motor (2 nos.)
    5. Electrical Control Panel
      1. M.S. powder coated panel is provided with all necessary contractors and relays and digital temperature meter with indicators and switches.
      2. Panel equipped with contractors of Siemens, Schneider, L&T or Telemecanique make.
    6. Air Filter
      1. 5 micron filter
    7. Gas Circulation System (Optional)
      1. Effective gas circulation during exposure phase, increase the sterility to products.
      2. Pump system 3 HP Crompton make electrical motor.
      3. Puff insulated duck line for effective circulation in the chamber.
      4. PLC automatic (with monitoring and graph system as per ISO 11135 (2007) (optional).
    8. PLC Based Automation Consists Of The Below Features
      1. HMI and PLC process automation
      2. Process automation hardware
      3. Process automation software
      4. Process PLC automatic software
      5. Detailed offerings in PLC based automation system consist of below instruments/features:
        1. PLC For The Process Automation
          1. Ladder logic control of process automation
        2. Process Automation Hardware
          1. Sensors:
            1. Kellner pressure/vacuum compound transducer: 1 (chamber wall mounting) (-1 to 3 bar, 4 to 20mAmp)
            2. Temperature sensors and transmitters: 19 (chamber wall mounting) (3-wire PT-100, 0 to 60°C, -5 to +5VDC)
            3. Relative humidity sensor cum transmitter: 9 (chamber wall mounting) (0 to 100% RH, linear 0.8 to 3.9 VDC)
          2. PLC Delta / Siemens
            1. Digital I/O – 8
            2. Digital O/P – 12
          3. PLC operating “Delta” HMI
            1. Touch screen (10”) panel mounted
          4. On/off control output channels
            1. Digital I/O card (8 channel capacity)
            2. Relay output card (8 channel capacity), to control on/off vacuum, steam inlet, ETO inlet, chamber exhaust, air inlet, water pump, gas circulation and alarm to control the programmed process parameters
          5. Input / output signal control box
            1. All the temperature transmitters are mounted in this box
            2. Power supply to run all the logical input signals and signal conversion devices
            3. Power supply for relay card, 230 V AC signals to the solenoid coils
            4. Front panel with indicator / switch for all the valve operations
            5. Auto/manual operation facility
          6. Auto control air operating pneumatic valve
            1. All the auto control valve 230 AC signals operating
              1. S.S ball valve (6)
              2. Rotex / Festo numeric valve with actuator (5)
              3. With all valve accessories
        3. Process Automation Software
          1. The software is flexible to take care of the sterilization process.
          2. All the cycle parameters like temperature, pressure, vacuum, and time are programmable.
          3. Different combinations can be programmed and named.
          4. Password facility for the security.
          5. During any sterilization cycle following are visible live on the monitor:
            1. A real-time graph of pressure/vacuum & temperature vs time.
            2. Digital and graphical display for temperatures.
            3. A simple cycle operation with a user-friendly interface.