BGS Beta-Gamma-Service plans first US sterilization facility

BGS Beta-Gamma-Service plans to open its first U.S. sterilization facility next year near Pittsburgh.

The 100,000-ft² plant will offer fully automated electron-beam (e-beam) sterilization in Imperial, Pennsylvania, near Pittsburgh International Airport. E-beam sterilization is one of the least-used but fastest-growing medical device sterilization methods due to its speed, effectiveness and relative safety.

The facility is expected to be operational in mid-2025 as BGS US LLC. Leonard Zuba, formerly VP of sales at Raumedic, will serve as the operation’s GM, while Bert Whitt will be operations manager.

Wiehl, Germany-based BGS said it’s the company’s first facility outside of Germany. The company provides e-beam sterilization services at its three sites in Germany, and expanded its logistics space in Wiehl (near Cologne) earlier this year.

“Pittsburgh’s proximity to key markets in the Northeast, Midwest, and South makes it an excellent location for our facility,” Zuba said in a news release. “Interest from customers and prospects regarding our ability to support them in the U.S. convinced us that there is a growing demand for e-beam technology in the United States. Government officials have been extremely helpful with accelerating the approval process for obtaining various permits.”

E-beam sterilization is an alternative to ethylene oxide (EtO or EO), which is by far the most common sterilization method but has come under new rules and regulations due to the risk of EtO emissions to facility workers and neighbors.

Gamma ray sterilization is another radiation sterilization alternative to EtO, but it requires Colbalt-60. That isotope’s radioactivity makes it a sabotage target and key ingredient in a hypothetical dirty bomb, a terror risk that spurred the Department of Energy’s National Nuclear Security Administration to encourage non-radioactive alternatives for medical device sterilization. Gamma ray sterilizers need Cobalt-60 replenishment annually, and it can take years to obtain for a new facility.

“The availability of sterilization capacity poses major challenges for U.S. manufacturers of medical devices, and pharmaceutical and biotechnology products,” BGS Beta-Gamma-Service GmbH Managing Director Dr. Andreas Ostrowicki said in the news release. “As a result, supply chain bottlenecks occur frequently. With our new plant in Pittsburgh, we are helping to meet the need for sterilization services with our ionizing radiation technology.”

BGS Beta-Gamma-Service provides beta- and gamma-ray radiation sterilization services for medical devices, pharmaceutical packaging and biotechnology products.

The privately held company says it has more than 200 employees and three facilities in Germany: Bruchsal in Baden-Wuerttemberg, Saal an der Donau in Baviaria, and its Wiehl headquarters in North Rhine-Westphalia.