ETO Sterilizer
ETO Sterilizer
ETO Sterilizer
ETO Sterilizer

ETO Sterilizer

 

Ethylene Oxide Sterilizers are designed to perform low temperature, chemical sterilization treatment of medical and pharmaceutical products sensitive to temperature/humidity. Machinfabrik EO Gas Sterilizers kill the toughest of microbes but are gentle enough to protect the integrity of the product and packaging. A wide range of program options, installation arrangements, and loading options increases the versatility. Whether you use external preconditioning and aeration or our unique Combined Process Systems, Machinfabrik can offer customized solutions for your most exacting needs.
EO Gas Sterilizers operate with a sterilant that is potentially explosive. Hence these Sterilizers incorporate design features, devices & additional means of protection in order to operate in the potentially explosive atmosphere in conformity with the established parameters ensuring a very high level of protection against explosions

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  • All MACHINFABRIK Sterilizers are designed to comply with ASME Pressure Vessel codes, current GMP norms, ISO 11135, EN 550, USFDA, EU GMP etc.

 

  • The 6mm thick chamber is fabricated with SS304 with high quality inert gas argon welding and is provided with round corners for easy cleaning and a 2% slope for full draining of the condensate. The chamber is re-enforced with a SS 304, 5mm thick jacket.

 

  • The chamber is also provided with a safety valve and compound gauge (on both sides) , RTD sensors, RH sensors and pressure transmitter.

 

  • The sterilizer is provided with one/two automatic sliding SS316L door reinforced with SS 304/mild steel. Mineral wool insulation is provided which is held in place by a stainless steel outer cover.

 

  • The door is automatically moved vertically / horizontally via a pneumatic cylinder to ensure the safety of the operator and the equipment during the entire operation.

 

  • Compound gauges for gasket pressure, with door status indications are provided on both Loading & Unloading sides.

 

  • The sterilizer chamber is insulated with 50-mm thick mineral wool, which is held in place by an outer cover of SS 304.

 

  • The chamber and doors are finished to a surface finish better than 0.8 micron Ra value. All other non-contact parts are polished to a surface finish better that 180 grit.

 

  • A carbon steel support structure supports the sterilization chamber and all components of the autoclave. No special foundation is required.

 

  • A water-ring / oil-sealed vacuum pump along with mechanical seal is provided along with the system. This Vacuum Pump is used for creating vacuum in the chamber for mechanical air removal prior to sterilization.

 

  • The vacuum pump can be mounted near the machine and is provided with a FLP electric motor.

 

  • An electric Steam Generator for humidification of the load is provided. The Steam Generator is fabricated from SS 304 with high quality argon welding. The steam generator is suitably insulated.

 

  • To maintain the desired temperature in the chamber, hot water is circulated through the jacket by a centrifugal pump.

 

  • For heating of the water, a S.S. 304 tank with water immersion heaters is provided

 

  • All process piping in contact with the chamber is fabricated from SS 316L with argon welding. All connections and fittings used are sanitary tri-clamp with silicone seals.

 

  • The process valves in contact with the chamber have SS 316L contact parts with Teflon seat and tri-clamp connections. All other valves have threaded connections.

 

  • For periodic validation and testing of the system, Validation Ports with tri-clamp connections are provided.

 

  • EO Gas Evaporator is provided for proper evaporation of the sterilant to ensure that only gas enters the sterilization chamber.
  • The chamber can be provided with SS316L perforated Shelves in case of smaller systems for easy loading & unloading.

 

  • The chamber can be provided with SS 316L carriage with removable Shelves (perforated/wire-mesh type) for loading. Each carriage is provided with four concave shaped wheels with sealed bearings impregnable to the steam.

 

  • Floor trolley is fabricated from SS 304 sturdy tubular members welded together with castor wheels.

 

  • The chamber is provided with SS 316L railing with circular cross-section. The rails can be easily removed for cleaning the chamber.

 

  • The functioning of the Ethylene Oxide Sterilizer is automatic and is controlled by a PLC. The PLC is operated with the help of a color, touch screen HMI with user-friendly features.

 

  • The PLC, instrumentation and electrical switchgear are housed in a SS 304 panel installed on the skid.

 

  • TEST & OPERATION PROGRAMS

 

  • Vacuum Leak Test
  • Sterilization Program 1.

 

  • For on-line process recording a data printer is provided in the control panel.

 

  • For ease of operation and safety of the operator all critical and non-critical alarms are displayed on the HMI as a text message and audio signal is provided via an audio buzzer.
  • Optionally, the following features can be provided in the system based on URS:- CE Marking, SS jacket, double gasket system, door heating mechanism, utility failure alarm, gas conditioning system, gas detection system, gas circulation blowers, EO gas manifold, gas weighing system, CO2 flusing system, emergency evacuation system, UPS.
  • The system can be optionally provided with Industrial PC (IPC) or PC with 21CFR Part 11 Compliant System.
  • After manufacturing and in-house testing customer inspection and testing can be performed as per in-house FAT protocol at our manufacturing facility.

MACHINFABRIK INDUSTRIES PVT. LTD.

MACHINFABRIK INDUSTRIES PVT. LTD.
Manufacturer
India

Primary focus area

Injectable / Sterile Unit

Analytical Products & Services

Project Management / Consultants

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