Pharma Tips

Ethylene Oxide Sterilizer - ETO - Operation

By: Pharma Tips | Views: 2359 | Date: 23-Mar-2012

At Machinfabrik, where innovation motivates us each day to move forward, development of the ethylene oxide sterilizer to meet the increasing demands of the stringent international standards of ASME, USFDA, EN285, ISO and HTM 2010, was a target that we had to attain.Because it is toxic and potentially carcinogenic, the use of EtO is under ever increasing regulatory scrutiny and control. Which makes the machine requiring a high level of sophistication and criticality of process control .

Introduction:

At Machinfabrik, where innovation motivates us each day to move forward, development of the ethylene oxide sterilizer to meet the increasing demands of the stringent international standards of ASME, USFDA, EN285, ISO and HTM 2010, was a target that we had to attain.Because it is toxic and potentially carcinogenic, the use of EtO is under ever increasing regulatory scrutiny and control. Which makes the machine requiring a high level of sophistication and criticality of process control .

With more than 25 successful installations, the ethylene oxide sterilizer proves its capability to adapt to a variety of products. Non-liquid products, contained in gas permeable packages not compatible with the heat or dry heat or steam sterilization, and not compatible with radiation sterilization, are candidates for sterilization with EtO gas.



Ethylene Oxide Sterilizer


Technique:

Ethylene Oxide (EO) gas permeates packaging and products at relatively low temperatures and kills micro-organisms by interfering with their protein and DNA. This process is enhanced by water vapor and therefore control of chamber humidity is important for effective sterilization
The sterilization cycle can be split up into 3 different phases:

1. Humidification phase this phase comprises of vacuum and steam pulsing followed by steam hold which impacts humidity to the load & this humidity in turn helps the sterilization process.

2. Sterilization.: the phase includes the injection of the ETO gas mixture that causes the sterilization of the products.

3. Air wash this stage comprises of mechanical vacuum creation, followed by pulsing with nitrogen or carbon dioxide gas so as to allow the ETO GAS to be released via scrubber.



Features:
1.SS.304 chamber design in compliance with ASME section VIII

2.Double gasket provision for safety operation.

3.Jacket heating system in provided to ensure jacket heat up before the sterilization process and hence ensure uniform temperature uniformity in the chamber

4.Gas evaporation system is provided to ensure gaseous sterilant even at low temperature

5.Gas circulation system in place to achieve uniform concentration of EtO gas. This is imperative for chamber volumes above 3 cubic.meter.

6.Gas detection system is provided as a safety measure for eto gas at minimum 3 locations to detect ETO leakage and set an audiovisual alarm .



Applications:

Eo sterilizers find typical application for plastic disposables, where steam sterilization is rendered inapplicable since the temperature ranges associate with steam sterilization may cause deformation of the product.

EtO is used for a wide range of products including blood oxygenators, catheters, tracheostomy tubes, mechanical heart valves, sutures, custom procedure kits, adhesive bandages, tubing sets, and so on.


Optional Features:
Normally the ETO used for gas sterilization is mixed with dilvents such as carbon dioxide or nitrogen in different proportions from 10 %eto to 90 % ETO.

The commonly used gas concentration in the sterilizers is 450 to 1000 mg/lit of chamber volume (measured as pure ETO).
Depending upon the concentration of the mixture, two cycles are employed
1. over pressure cycle for lean mixtures (10 to 20 % ETO)
2. vacuum cycle for rich mixtures (90 to 100 & ETO)

Gas scrubber :
With our strong commitment to environmental protection and social conciousness we have developed the gas scrubbing system for converting the ETO gas exhausted from the chamber to ethylene glycol a bio friendly substance which can be easily discharged into the sewage.


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Comments
ETO Sterilizer  |  02-Oct-2015 14:23:44 IST
This is fantastic article regarding the ETO Sterilizer. Please keep coming more about eto sterilizer and sterilization process.
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