Eto Sterilizer

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Details of Eto Sterilizer

ETO Sterilizer is highly effective sterilizing equipment. It is perfect for heat sensitive tools and devices as it uses only ethylene oxide gas for sterilizing the substances and does not entail high temperature processing. We are the leading ETO Sterilizer Manufacturer in India. Our equipments are incredibly powerful for killing miscellaneous types of micro-organisms along with their spores. Our E.T.O Gas Sterilizer is absolutely safe, effective and ecological in nature.

Since we make high quality equipments, we are the leading ETO Sterilizer Supplier in India and supply to prominent cities like Surat, Nagpur, Coimbatore, Bangalore, Guntur, Indore and Vijayawada etc.

 

(Why E.T.O  Sterilization Process)

ETO Sterilizer 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.

EtO gas infiltrates packages as well as products themselves to kill micro organisms that are left during production or packaging processes. This gas, mixed with air at a ratio of at least 3% EtO gas, forms an explosive mixture. Pure EtO gas boiling point is 10.73 ºC at atmospheric pressure. Most of the time, it is mixed with Nitrogen or CO2. This explosive condition requires Intrinsic Safe material (ATEX) zoning, for security of people as well as security of the process itself.

Safety of personnel is an important issue due to the harmful effect of EtO on humans. Polluted areas need to be alarmed using gas detectors set up at different locations to monitor any leak. Visual and audio alarm systems need to be provided. The system must inform any operator when a sterilization cell contains EtO.

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.

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EtO Sterilization process: Step Wise

ETO Sterilizer has three stages of operation.These can be separated into three different cells depending on the size or amount of devices to treat:

  • Pre Conditioning
  • Sterilizer
  • Degasser

When cells are separated, automated loading/unloading systems are required. These save operator time as well as  giving protection from exposure to a polluted environment, which could be detrimental to health.

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Pre Conditioning Stage:

First, products need to go through a pre conditioning phase to make micro organisms grow. The batch load goes through a dwell time under a controlled environment of:

  • Temperature
  • Humidity

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Sterilizer Stage as Per Norms :
Then the load goes through a long and complex sterilization cycle. Requirements of such a system are:

  • Accurate temperature control.
  • Availability of the control system.
  • Accurate pressure and vacuum control.
  • Easy displays of process phases
  • Dedicated customer recipes.
  • Auto batching release through tolerance tests.
  • Reporting.
  • Security interlocks between actuators.
  • Alarming.
  • Shut down strategies.
  • Audit Trail facilities – Trending.
  • 21CFR Part11

 

During this cycle, accurate temperature control is important and a heating jacket is used. As the overall duration of this cycle is around 60 hours, high availability of the system is vital and system redundancy is required. Doubling sensors, actuators and controllers as well as changeover facilities on these components, helps to ensure the product is sterilized even on hardware or software failure.

After the doors have been shut down and sealed correctly, the cycle can be started either manually or automatically. If any problem with door sealing is detected the cycle is interlocked and cannot start. Security interlocks are also used between air and EtO valves.

Once the cycle is started, easy to use displays are required to show:

  • The actual phase of sterilization
  • All the key set points and tolerances as loaded by the recipe
  • All the key process values for the auto batch release facility

 

Control of vacuum and pressure is also required. Due to the toxic effect of EtO, water ring rotary pumps are used. The vacuum process needs to perform the emergency evacuation phase for a fast evacuation of gas.

The sterilization phases are:

  • Cycle start delay to enable the system to start in stable conditions
  • General cell temperature check
  • Initial vacuum phase
  • Leak rate test
  • First flush
  • Second flush
  • DEC (Dynamic Environmental Conditioning)
  • EtO gas injection
  • Sterilization dwell time period under EtO
  • Post dwell vacuum level
  • First wash
  • Second wash
  • Final air admission
  • Final chamber re-evacuation delay

 

During execution of these phases a batch report is generated. This report will include: tolerance checks, phase changes, alarms, events and critical process values. A key feature of the system is “auto batch” release. During the sterilization cycle if any abnormal condition occurs, the batch will be automatically stopped and condition(s) causing the stoppage will be identified. With this “auto batch” release facility operators do not have to wait until the end of the cycle and spend time going through the batch report to understand why it went wrong. With this feature, provided that batch is completed satisfactory it will be automatically forwarded to the degassing room without human check of tolerance, process values and alarms.

For each batch the operator selects appropriate product recipe. After recipe has been downloaded, the operator is given the opportunity to check if values are correct for this particular batch before starting the cycle.

When the batch is over an automatic print of the report can be performed. Batch logged files are also archived electronically for future review. Batch logged files could be searched by the following:

  • Batch ID
  • Customer name
  • Recipe
  • Product type
  • Start and stop time

 

Degasser Stage :
Finally, products need to go through a degassing phase to remove any particle of EtO. The batch load goes over a dwell time under a temperature controlled environment

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ADVANTAGES & DISADVANTAGES OF ETO STERILIZER

ADVANTAGES OF ETO STERILIZER

  • ETO Sterilizer equipments are very effective and reliable in destroying the pathological micro-organisms along with their spores.
  • They are perfect for devices and substances that cannot tolerate high temperature.
  • This process is ideal for humidity sensitive devices too.
  • They are material compatible. They can perform the sterilization operation on almost any kind of material.


DISADVANTAGES OF ETO STERILIZER

  • They can carry out ETO Sterilization process only batch by batch and are not at all apt for continuous processing.
  • The process is a bit lengthier than steam sterilization or other methods of sterilization.



CONTAINS SHOULD BE CONSIDER FOR FOOD, SPECIES AND MEDICAL

Sterilization  is a term referring to any process that eliminates (removes) or kills all forms of microbial life, including transmissible agents (such as fungi, bacteria, viruses, spore forms, etc.) present on a surface, contained in a fluid, in medication, or in a compound such as biological culture media.Sterilization can be achieved by applying the proper combinations of heat, chemicals, irradiation, high reassure, and filtration

The term has evolved to include the disabling or destruction of infectious proteins such as prions related to Transmissible Spongiform Encephalopathy (TSE).


Ethylene oxide sterilization is a chemical process consisting of four primary variables: gas concentration, humidity, temperature and time. Ethylene oxide is an agent that disrupts the DNA of microorganisms, which prevents them from reproducing. EO sterilization assures that a safe and sterile product will be delivered to the market each and every time.

Regulatory and Safety :- From last  few year, the European Nerus and regulation enabled Medical Devices manufacturers to have dramatically improved the safety levels of Ethylene Oxide usage in indicated context to rationalize the ethylene oxide sterilization process while increasing its level of security.

 

  • Design/ Construction: EN 14 22 , FDA 21 CFR Part 11
  • Process/ Validation: EN 550, ISO 11 135, AS1210


Our References For Foods & Spice Industries

  • JEBS International ( Mumbai) 4 Units Supply. ( Mr.Jagdish Bhai Patel ).
  • SRSS Agro Foods P. Ltd ( Delhi )3 Units Supply. ( Mr. Shyam Gupta)
  • ACURA Organic Foods. ( Ahmedabad ) 2 Units Supply. ( Mr.Deepak Bhai ).
  • ASIAN Foods ( Nadiad ) 1 Unit Supply  ( Mr.Ajay Bhai ).
  • KIZ Food ( Mahuva ) 2 Units Supply ( Mr.Altaf Bhai ).
  • AUTOMAN Industries ( Mumbai ) 2 Units Supply. ( Mr.Manoj Bhai )
  • SirGin Helath Care.Mr Amit
  • VGM Polymers Mr.Vinay Gupta
  • Perfect Surgical Mr.Mukesh Karnal 09416034857


Our References For Hospital use

  • Anand Surgical Hospital Ahmedabad Mr.Singvai 
  • Bharti Eye Clinic Dr. Mahesh
  • Sukhmani Hospital .Ahmedabad
  • Pecific medical collage & Hospital Dr. Vivek Trivedi.
  • Medical collage of Hospital Bhopal .
  • Raigadh Medical Collage :- Maharashtra
  • Vishantha Surgical. Mumbai