Issue



Boosting IEST recognition is goal for newly elected contamination control VP


08/01/2003







By Mark A DeSorbo

Gordon Ely has recently been elected technical vice president of contamination control, a post on the executive board of the Institute of Environmental Sciences and Technology (IEST; Rolling Meadows, Ill.)

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For nearly 13 years, Ely has worked in various capacities at Nelson Laboratories, Inc. (Salt Lake City, Utah), an independent testing laboratory that serves the medical device, pharmaceutical and biotech industries.

He is section leader of Nelson's IDs/Packaging section, specializing in microbial identifications and packaging validations. Ely has also worked in and supervised cleanrooms and controlled environments. He is certified through The National Registry of Microbiologists (NRM) as a Specialist Microbiologist (SM) in Consumer and Industrial Microbiology (Pharmaceutical/Medical Device/Cosmetic).

Along with his position with IEST, Ely is also a member of the Association for the Advancement of Medical Instrumentation (AAMI; Arlington, Va.) and involved with various working groups within these organizations, as well as ISO technical committees.

He received a Bachelor of Science degree in microbiology, with a minor in chemistry, from Brigham Young University.

CleanRooms recently spoke with Ely about his goals for the IEST:

CleanRooms: Is this the first time you've been elected to the board of an industry organization?

Gordon Ely: This is the first time I have been elected, since it is the first time I have ever run for a position on a board. After much deliberation and getting clearance and support from my company, I decided to run. I felt it was an opportunity for me to use my experiences as a microbiologist and in the contamination control industry, as well as my experience in a wide variety of working groups with IEST and AAMI, to further the mission of IEST.

CR: What do you hope to accomplish in this new role?

GE: I want to help IEST to become more recognizable. When someone talks about cleanroom standards, IEST should instantly come to mind as the organization to turn to. It's amazing how many people in the industries I work in do not know that there is such an organization. I also hope to be able to get more participation and involvement from those who use cleanrooms and are concerned with contamination control.

This is especially true for the pharmaceutical, medical device, and biotech industries. There are few people from these industries currently involved or even members with IEST. It is through greater involvement from all industries that quality, well-rounded standards and recommended practices will be written and published. This is my third goal: to help IEST produce the best documents possible. All these goals are inter-related in that without the success of each, it will be difficult to achieve any of them.

CR: With platforms delving into the nano-range, will particle classification need to be revamped?

GE: Classification will only need to be revamped if it is determined to be a need by the industry. Instead of totally revamping classification, I think it would need to be amended to include extreme levels of cleanliness without changing the current classification system. Names of levels would change, as was done from the Federal Standard 209E to ISO 14644-1. No change could be made, even if there was a need, until technology was developed and available for testing in the nano-range.

CR: What do you think are the most significant obstacles the contamination control industry will fac

GE: Rather than looking into the future too far, there are obstacles facing the industry now. One is awareness. There are many people who know very little or nothing about contamination control who really should. These people need to know why contamination control in their respective industry is so important and how it is done. There is a need for people to be trained in contamination control and to use the standards
ecommended practices available. Another obstacle is the concentration of the contamination control industry on particles (non-viable) and molecular contaminants. Not enough attention is given to viable particles (bacteria, fungi, viruses, etc.). These are important contaminants that need to be dealt with in all aspects of the industry. Once more focus is given to viables, we may be surprised at how many contamination control problems they create.