Gas Sterilizers

Process Control and Other Features:

1.       STATE OF THE ART – VACUUM SYSTEM:

Heavy Duty Branded- Oil free diaphragm type vacuum pump is provided to remove the air/gas from the chamber.

2.        AUTOMATIC HUMIDIFICATION SYSTEM:

The machine is equipped with inbuilt automatic humidification system and is able to maintain humidity in the chamber within the range of 80 to 85% automatically controlled by wet and dry humidity transducer system.

3.       AUTOMATIC LOW WATER CUT OFF SYSTEM:

The machine is equipped with automatic low water cut-off system. When the water level decreases below a threshold then heating elements will automatically turn off. The user will be notified in case the water level is not optimum for regular machine operation.

4.        AUTOMATIC PRESSURE CONTROL SYSTEM:

Pressure of the sterilant is controlled automatically through pressure sensor.

5.        AIRTIGHT SEALING:

Heavy Duty branded silicon gasket will be provided for airtight seal.

6.        ANALOGUE GAUGE:

The Sterilizer is fitted with branded NABH calibrated analogue chamber compound gauge to measure the pressure and vacuum of chamber.

7.        DIGITAL CHAMBER TEMPERATURE CONTROLLER:

The Sterilizer is fitted with digital chamber temperature controller and indicator to indicate & control the chamber temperature.

8.        DIGITAL HUMIDIFICATION TEMPERATURE CONTROLLER:

The Sterilizer is fitted with digital humidification temperature controller and indicator to indicate & control the chamber temperature.

9.        CATALYTIC EXHAUST CONVERTER:

Catalytic convertor is provided to treat the ETO gas before exhaust.

10.     DOOR FEATURE:

The sterilizer has single door with wing nut locking system.

Door opening safety:

Door will be open only at the end of cycle and only when chamber is at room pressure and desired chamber temperature is reached.

11.     FLUSH MOUNTING:

The sterilizer is equipped with SS 304 flush mounting of front side.

12.     EUROPIAN STYLE PANELLING:

The sterilizer has fully covered design with panelling back, top and both the sides RHS & LHS.

13.     SAFETY FEATURES:

13.1   HYDRAULIC  TESTING:

Complete sterilizer including chamber and piping are hydraulically tested at 2 times the working pressure.

13.2   SAFETY VALVE:

The sterilizer is fitted with spring loaded safety valve.

13.3    INSULATION:

The sterilizer is completely insulated to prevent any burns caused due to accidental contact to sterilizer body.

Ethylene Oxide (EO or ETO) Gas is a crucial method for sterilizing delicate items like plastics, optics, and electronics, which are sensitive to high temperatures and radiation. Operating within the range of 30°C to 60°C, with humidity levels above 30% and gas concentrations between 200 and 800 mg/l, this treatment typically spans a minimum of three hours. Renowned for its exceptional penetration abilities, ETO effectively eliminates viruses, bacteria, fungi, and even spores, rendering it compatible with various materials, including medical devices. However, its usage entails significant risks due to its flammable, toxic, and carcinogenic properties.

Ethylene oxide sterilization hinges on four pivotal factors: gas concentration, humidity, temperature, and duration. By disrupting the DNA of microorganisms, ETO halts their reproduction, ensuring consistent delivery of safe and sterile products to the market.

Process Control and Other Features:

 

1. AUTOMATIC CONTROL SYSTEM:

The Machine is equipped with automatic control system by Pre-programmed PLC.

Note:- Dual (Automatic & Manual operating) control system will beprovided at extra cost with this model.

 

2. PRE-PROGAMMED CYCLES:

The sterilizer has equipped 4 pre-programmed cycles as mentioned below:

a) 3 Cartridge Cycles:

Warm Cycle

Cold Cycle

Customer Flexible Cycle

b) 1 Cylinder Cycle.

 

3. PASSWORD PROTECTION:

a) The sterilizer settings are password protected.

b) The date and time settings are password protected, and User is able to update date and

 

 

time settings on the screen for better record keeping.

 

4. FULLY AUTOMATIC OPERATION NEGATIVE PRESSURE CYCLE (100% ETO CARTRIDGE) CYCLE DESCRIPTION:

a) Vacuuming of chamber to set value

b) Leak hold period

c) Cartridge punching /gas purging depending on the cycle selected

d) Sterilization hold period for set time

e) Exhaust and aeration for no. of aeration pulses set

 

5. EACH CYCLE FOLLOWS THE BELOW MENTIONED PHASES:

a) CONDITIONING: Chambers are heated by electrical resistance or by steam contained in a jacket surrounding the chamber.

b) INITIAL EVACUATION: To safely deliver the 100% ethylene oxide process, at least 97 percent of the air is removed from the chamber and is achieved byperforming a series of partial vacuums and pulling deep vacuum using vacuum pump.

c) HUMIDIFICATION: This is accomplished by adding humidity in the form of steam injections after the addition of steam, the product is allowed to dwell or soak for time required to replace the moisture lost from the evacuation phase.

d) EXPOSURE (STERILIZING): liquid ethylene oxide is first heated into a gaseous phase, then injected into the chamber.

e) EXHAUST/DEGASSING: After the exposure phase of the process, all gas are removed from the chamber until the levels of EO fall below the flammable limit for the gas (3 percent or 30,000 ppm).

a) AERATION: The sterilized contents are aerated to remove ETO residue withinthe sterilizer chamber.

 

6. AUTOMATIC FAULT DETECTION SYSTEM:

a) The Machine is equipped with Faulty Sensor Detection system and user is visually notified of the same.

b) The machine is equipped with temperature detection system and the user will be notified in case the machine fails to reach the set temperature or if the temperature overshoots

c) The machine is equipped with water detection system. The user will be notified in case the water level is not optimum for regular machine operation.

 

7. PRINTER:

a) The user is record the progress of the sterilization cycle in real time therefore online real time printing facility will be provided.

b) The user can print the following details:

Date and time of the cycle.

Status of the cycle.

 

 

Temperature at drain and chamber pressure at every event change and during sterile hold it can be printed at desired interval, minimum of 1 minute.

All undesired situation (faults) are to be printed at the time of fault generation.

 

8. CYCLE DATA STORAGE FACILITY:

Historical cycle data gets stored in the memory of sterilizer which can be easily retrieved at will through USB.

 

9. STATE OF THE ART – VACUUM SYSTEM:

Heavy Duty Branded- Oil free diaphragm type vacuum pump is provided to remove the air/gas from the chamber.

 

10. AUTOMATIC HUMIDIFICATION SYSTEM:

The machine is equipped with inbuilt automatic humidification system and is able to maintain humidity in the chamber within the range of 80 to 85% automatically controlled by wet and dry humidity transducer system.

 

11. AUTOMATIC LOW WATER CUT OFF SYSTEM:

The machine is equipped with automatic low water cut-off system. When the water level decreases below a threshold then heating elements will automatically turn off. The user will be notified in case the water level is not optimum for regular machine operation.

 

12. AUTOMATIC PRESSURE CONTROL SYSTEM:

The sterilizer has automatic pressure control switch which automatically maintain the desired pressure and restricts any abnormal/ unsafe rise of pressure in the sterilizer.

 

13. AIRTIGHT SEALING:

Heavy Duty branded silicon gasket will be provided for airtight seal.

 

14. PNEUMATIC VALVE:

The sterilizer is equipped with branded pneumatic valves for automatic process.

 

15. ANALOGUE GAUGES:

The Sterilizer is fitted with branded NABH calibrated analogue chamber pressure (Compound) gauge to measure the pressure and vacuum of chamber.

 

16. CHAMBER TEMPERATURE CONTROLLER:

The Sterilizer is fitted with chamber temperature controller to control the chambertemperature.

 

17. HUMIDIFICATION TEMPERATURE CONTROLLER:

The Sterilizer is fitted with humidification temperature controller to control thechamber temperature.

 

18. CATALYTIC EXHAUST CONVERTER:

Catalytic convertor is provided to treat the ETO gas before exhaust.

 

19. FLUSH MOUNTING:

The machine is equipped with SS 304 flush mounting only (Front side) Non-Sterile side.

 

20. EUROPIAN STYLE PANELLING:

The sterilizer has fully covered design with panelling back and both the sides RHS & LHS.

 

21. DOOR FEATURE:

a) The sterilizer has single door with wing nut locking system.

b) Door opening safety:

Door will be open only at the end of cycle and only when chamber is at room pressure and desired chamber temperature is reached.

 

22. SAFETY FEATURES:

22.1 EMERGENCY STOP:

An Easily Accessible emergency stop is provided on main control panel door.

22.2 POWER FAILURE:

Equipment settings will not get disturbed due to power failure and will not restart without human intervention.

22.3 FAILURE MODE DETECTION:

Equipment indicate fault through audio / visual signal with details on Control panel/PLC (Failure mode detection).

22.4 HYDRAULIC TESTING:

Complete sterilizer including chamber, jacket, and piping are hydraulically tested at 2 times the working pressure.

22.5 AUTOMATIC DUAL DOOR LOCKING SYSTEM:

5.a) AUTOMATIC ELECTRONIC DOOR LOCK:

The sterilizer is fitted automatic electronic door locking mechanism system.

5.b) AUTOMATIC MECHANICAL DOOR LOCK:

The sterilizer is equipped with automatic mechanical door locking system which prevents the user to open the door until the atmospheric pressure is achieved inside the chamber.

22.6 SAFETY VALVE:

The sterilizer is fitted with pop up type dual safety valves.

22.7 INSULATION:

The sterilizer is completely insulated to prevent any burns caused due to accidental contact to sterilizer body