As medical devices are becoming more complex, sterilization requirements are also becoming more stringent. BeamOne LLC (San Diego) is addressing the increasing need for E-beam sterilization by establishing a new service center in the Pittsburgh area.
“Today’s products require small batch processing, tight dose tolerances, temperature control, time limits for sterilization, and quick turnaround,” says Tom Stephan, vice president of business development at BeamOne. “All of this can be achieved with E-beam sterilization due to the small amount of product in the radiation area at any time and the flexibility of the product handling system to accommodate single devices to trailer load quantities.”
According to Stephan, E-beam sterilization is the fastest-growing sterilization method for single-use medical devices. The process also has a turnaround time between four and 48 hours.
“E-beam systems use electricity to accelerate a stream of electrons to 99.999% of the speed of light,” Stephan says. “These high-speed electrons distribute ionizing energy throughout the product as it is conveyed through the electron beam. E-beam radiation, due to its high dose rate, is recognized as ‘polymer-friendly’ and often has better polymer performance than gamma radiation, and this continues to drive manufacturers to conversion from gamma to electrons.”
The new 25,000-sq-ft facility near Pittsburgh is scheduled to be operational by the beginning of October 2010. The center features process segregation, a 10-MeV linear accelerator with radiation shield, and a fully automated product conveyor system that has an annual capacity of more than 3 million cu ft of medical devices. It will also offer logistic services such as direct shipment or cross docking for customers that have multiple distribution centers. Last year, BeamOne expanded its service centers in California, Colorado, Ohio, and Costa Rica.
The company’s conveyor systems also have a patented rotate system that enables double-sided irradiation without the need for manually rotating product boxes or requiring a product to exit the irradiation area in between processing each side.
As for future plans, the company has identified several potential locations for further expansion and is negotiating service commitments with regional manufacturers to install E-beam technology. —Maria Fontanazza