Nelson Labs to Provide Testing and Validation Presentations

SALT LAKE CITY – June 2, 2010 – The best techniques for assuring cleanliness and sterility of medical devices will be the main emphasis of Nelson Laboratories’ ( experts who will provide four presentations to help guide manufacturers in making the best testing decisions for their products during the Medical Design & Manufacturing East (MD&M East) show June 8-10.

Dan Floyd, sterilization section leader at Nelson Labs, has also been invited to present at the Innovations Brief on Ethylene Oxide (EO) sterilization validation.

“Testing to ensure manufacturers build-in proper cleaning and sterility processes in their assembly lines is imperative,” said Jeffery Nelson, Nelson Labs CEO. “We hope to assist device makers in getting their products to market quickly and easily by providing these presentations on the tests their devices may need and why they are necessary.”

Nelson Labs will conduct the presentations hourly at their exhibit booth (#2546). The topics include:

  • Cleaning Validation for Newly Manufactured Devices: How can I tell if my device is really clean?
  • Ethylene Oxide: EO exposures for functionality/feasibility/biocompatibility
  • Bacterial Endotoxin Testing and alternatives to batch testing
  • EO sterilization validation including batch release

Floyd’s 30-minute Innovation Briefs presentation (booth #2673) will delve into one of the most popular forms of sterilization—ethylene oxide gas.

Ethylene oxide sterilization is accepted as a sterilant by the Food and Drug Adminstration and is great for products that are heat sensitive or sensitive to radiation. It sterilizes by interacting with nucleic acids and other cellular processes to kill microorganisms on the device.

“Nelson Laboratories provides a wide range of ethylene oxide testing to help manufacturers determine the variables to properly sterilize their products,” said Floyd. “The EO sterilization process is an overkill one, which means the validation determines the levels and exposure of the gas to the product necessary to kill microorganisms in half the time that will actually be used in the sterilization process.”

If there are failures in the test then some of the variables need to be changed and the validation process repeated. The most common variable to be changed is exposure time, but can also include heat, humidity, and the amount of gas. Increased exposure time can usually ensure sterilization takes place.

Nelson Labs provides the EO validation tests, but can also educate on sterilization standards and assist in fixing failures for new manufacturers or for established manufacturers who are building in new processes.

Floyd will present June 10 at 10:30 a.m. This and other topics can be discussed at length at the Nelson Labs booth.

About Nelson Laboratories

Based in Salt Lake City, Nelson Laboratories is a leading provider of full, life-cycle microbiology testing services. The company is known for exceptional quality, but looks beyond the testing process and partners with its customers to achieve long-term business goals. It’s called The Science of Success™. It’s transparency in the testing process. It’s approachable experts that guide you through ever-changing compliance requirements. It helps mitigate risk, be first to market, and succeed with customers.