TM Electronics, Inc.
45 Main Street, Boylston, MA 01505
Phone: (508) 869-6400
E-mail: sales@tmelectronics.com
Website: www.tmelectronics.com

For Immediate Release
3/11/08

TME's Steve Franks Presents "Sterility in Jeopardy: Choosing a Package Integrity Test Method" at HealthPack 2008

Boylston, MA: TM Electronics' Executive Vice President Stephen Franks was recently featured as a presenter at the HealthPack 2008 conferences in San Antonio, Texas, where he spoke on the topic "Sterility in Jeopardy: Choosing a Package Integrity Test Method".

Using a light-hearted theme based on the "Jeopardy" game show, Mr. Franks walked the audience through an examination of the complex process of determining the best package integrity test method for a medical package. He began with the concept of a universal standard to protect the sterility of a sealed medical package, referring to it as the "Holy Grail" of medical package testing, and then discussed why there can be no single answer. Referring to studies out of Michigan State University, Mr. Franks illustrated the process followed to obtain information on the size of a hole that would compromise sterility under very controlled conditions on one size and shape of package.

Having established that there is no single standard or universal test method to assure sterility, Mr. Franks then proceeded to discuss in detail the use of AAMI/ANSI/ISO-11607 and TIR-22 as a foundation for researching test methods. He also explained the importance of considering consensus standards because the basic studies in repeatability, reproduceability and sensitivity have been done, although he stressed that any test method, even the FDA's consensus standards, must be validated using your own product and equipment.

In conclusion, Mr. Franks provided tables describing package integrity (seal strength and leak integrity) test methods that are consensus standards, their strengths and weaknesses, applicability, and relative cost, as well as an overview of methods that are not consensus standards but are in relatively common use.

Developed in 1991, the HealthPack conference is specific to medical device packaging. HealthPack is dedicated to creating a forum for ideas and solutions to help medical device professionals create efficient, innovative packaging. HealthPack includes a full conference agenda combined with table-top exhibits providing opportunities for attendees to focus on key industry issues while addressing individual needs with leading suppliers and service vendors. Welcome reception, continental breakfasts, luncheons, meetings and breaks encourage ongoing networking among attendees, speakers and exhibitors. TM Electronics will again be exhibiting their package testing equipment at HealthPack 2009 in Memphis. More information about HealthPack can be found at www.healthpack.net.

Back to List