Sterigenics Makes Deal to Reopen Willowbrook Sterilization Plant

Following the shutdown of an Illinois Sterigenics plant in February of 2019, a deal has been made for it to be reopened, pending approval from the DuPage County Circuit Court. According to a Medtech Dive post, the closure of the Willowbrook plant caused losses of millions of dollars for medical device manufactures such as Medtonic, Boston Scientific, and Smiths Medical.

The plant was originally shut down due to an Illinois Environmental Protection Agency finding of high levels of ethylene oxide emissions, which are carcinogenic and linked to breast cancer, lymphoma, and leukemia. Approximately half of all medical devices use a method of sterilization that uses ethylene oxide emissions. Until alternative methods are developed, the medical device industry has been actively lobbying the government to allow access to ethylene oxide as a sterilant. However, the Food and Drug Administration has recently launched two innovation challenges to promote the development of alternative sterilization methods.

Under the agreement, ethylene oxide use for sterilization would not be allowed for commercial purposes until Sterigenics implements new emission control systems that capture 100% of the gas in the facility. The efficiency of these systems would have to be 99.9% and must be approved by the Illinois Environmental Protection Agency before the Willowbrook operations are permitted to resume.

“We are pleased to have reached this agreement, which creates a path for our Willowbrook facility to resume its safe operation and includes no finding of wrongdoing on the company’s part nor the imposition of any financial penalties,” said Sterigenics President Philip Mcnabb.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.