The sterilization Ethylene Oxide process requires an important know-how to achieve an optimal and effective sterilization. In addition, it is required to master the process to protect the installation as well as the users, as this gas is explosive, inflammable, mutagenic and cancerigenic.
For all these reasons, it is important to rely on a strong specialist team having a deep experience in that sector, in terms of process, normatives or installation & start up for instance.
Sterilization by Ethylene Oxide (ETO) is very effective and uses to achieve great results, but to get them and to comply with all the existing normatives and directives, you must have all the information and the appropriate training.
What is an Ethylene Oxide sterilization consultant?
As the other consultants, he is a professional (in this case specialized in ETO sterilization), which means that he has to have all the knowledge in the matter and a long experience to be able to advise the client at any level.
What are the characteristics of an Ethylene Oxide sterilization consultant?
Apart from having some virtues more typical of the character, his main characteristics are:
- To know how to identify the limits, the objectives, ...,
To know "what to do" but even more "to know how and when to do it",
- To be able to give alternatives,
- His Know-how, essential in the Ethylene Oxide sterilization, has to be complete and should be extended to all the ETO sterilization aspects (processes, operations, facilities, autoclaves design, calculations, validations ...). He also have to have his knowledge up to date regarding normatives and legislation, as well as the last technologies.
What kind of services a consultant can offer?
The main function of a consultancy is to advise both in the ethylene oxide sterilization process and in everything that involves an ETO installation (sizing, layouts, PID, URS, design, norms to comply with, existing installation upgrade…).
RSD® offers consultancy services based on Ethylene Oxide sterilization. Some examples of what we can propose:
- Cycles optimization for Ethylene Oxide (ETO);
- Cycles of sterilization validations;
- Sizing of an installation of a sterilization autoclave by ethylene oxide according to the requirements of each client;
- Calculations of the services (N2, EO, chiller water, steam,...), necessary for the operation of a sterilizer by ethylene oxide;
- Advice to follow the current European directives 2014/34 / EU (new ATEX directive in force since 04/20/2016 repeal the ATEX directive 94/9 / CE) & 1999/92 CE (ATEX);
- Existing facility upgrade, for compliance with ATEX directives;
- Implementation of the parametric release on sterilizers ethylene oxide (ETO);
- Flammability calculations to stay in a non-explosive zone;
- Return on investment calculations for an ethylene oxide (ETO) sterilization project;
- Writing quality protocols;
- Consultations and advice on technological, strategic and operational problems;
Other consultancy services focused on steam sterilization can be offered.
When do their advices can be required?
We may need to go with an ethylene oxide sterilization consultant when specific services are required:
- Ethylene Oxide installation upgrades. It could be to comply with the current directives that are updated quite often, installation growing or upgrading to make it more modern ....
- New investment. It has been decided to expand the company services, and the purchase of an ethylene oxide sterilization equipment should be done (process understanding, staff training, URS definition…).
- Process changes. It has been decided to start sterilizing by ETO the own company products.
- Necessity to carry out a safety audit.
- Requirement to optimize and validate the ETO sterilization cycle (essential for optimal sterilization, more information about the sterilization cycle).
- Redaction of quality protocols.
- Necessity to perform calculations for installation utilities, flammability diagram, return on investment...
There is no doubt that in order to achieve the objectives, you should surround yourself with real professionals that perfectly understand the process of sterilization by ethylene oxide.
If you are looking for a consultancy focused on ethylene oxide sterilization, do not hesitate to contact us.
RSD®, with its more than 15 years of experience in this sector at international level, will enjoy to give you support.