ISO 11135 Revision to Be Highlighted During Sterilization Seminar

Medical device manufacturers interested in ethylene oxide sterilization can learn about the 2014 revision of ISO 11135, "Sterilization of Healthcare Products -- Ethylene Oxide -- Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices," at an upcoming seminar. Organized by SteriPro Laboratories & Consultative Services, a subsidiary of sterilization services provider Sterigenics International, the three-day seminar also will cover sterilization using gamma radiation and electron beam and will take place on August 19 to 21, 2014, in Downers Grove, IL. 

Camilla Andersson

The revision of ISO 11135 will be a key topic at the seminar. Several consultants from Sterigenics were on the ISO committee that developed the standard, and they will discuss the draft revision issued for public review. The seminar also will feature representatives from AAMI who were involved in developing the standard, as well as the international notified body BSI.

The revision will merge two previous standards, ISO 11135:1 and ISO 11135:2, into one and will become official in the next couple of months, says Bill Young, vice president of Sterigenics. 

When asked what the most significant parts of the revision are, Young cautioned MDMs to review the complete revision.
“This is a comprehensive document, and to identify some details takes away from the need to review this in its totality,” says Young. "I would suggest that any medical device manufacturer looking at what the requirements are find an organization or group such as SteriPro to sit down and walk through the standard and see how it affects their particular sterilization programs.”

MDMs are increasingly using ethylene oxide sterilization for their products. This trend is partly a result of new materials and products that are too sensitive for other sterilization methods, as well as advances in ethylene oxide equipment that means the method is much safer than it used to be.

“Ethylene oxide has grown over the years because it has been found that the more methods that we look for, the more ethylene oxide appears to be the most reliable and consistent for the largest amount of products,” says Young.

The introduction of more advanced equipment, which allows users to control the process better than previously, also is driving the trend towards ethylene oxide, says Young. This reduces the risks of using the potentially toxic and explosive gas.

“We have been able to innovate the process and been able to control it,” says Young. “It is a very sophisticated process today as compared to 50 years ago when it was first being used. Through the use of some of the computerized controls and equipment that we have, as well the evaluation of the concentration of the EO gas, we are able to minimize the use of gas while maintaining the same sterilization levels.“

A relatively new trend in ethylene oxide is the application of parametric release, which traditionally has not been used for this sterilization method.

“SteriPro Labs helped put some of the largest medical device companies into parametric release over 10 years ago,” says Young. “What we see today is that companies still don’t realize that they have options, or are not sure how to perform parametric release, or how to move in a direction that is more expeditious in having their products sterilized and released more quickly."

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By Camilla Andersson
Freelance Journalist

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