Wiehl, Germany-based sterilization provider BGS Beta-Gamma-Service GmbH & Co. KG is expanding with a new location in Pittsburgh to meet increasing demand for sterile medical devices and consistently accessible sterilization capacity in the U.S.
The facility will specialize in fully automated e-beam irradiation, an effective alternative to gamma and ethylene oxide (EtO) sterilization for medical devices, a Sept. 10 news release said. Gamma irradiation and treatment with EtO are historically the most widely used techniques in the U.S. sterilization market.
The construction of the facility "is progressing as planned," Lena Prinz, head of corporate communications for BGS, told Plastics News in an email. "The facility layout was planned to optimize material flow around the brand-new electron accelerator and automation system."
BGS US will begin operations in mid-2025, the release said.
"The U.S. facility was designed with future growth in mind," Prinz said. "We are anticipating strong interest, particularly from medical device manufacturers, and have planned accordingly to allow for capacity expansion as demand increases."
"A lack of sterilization capacity has put pressure on U.S. medical equipment manufacturers and could potentially cause supply bottlenecks," Andreas Ostrowicki, managing director of BGS, said in the release. "With our new facility in Pittsburgh, we are helping to eliminate them."
"Uncertainties surrounding the environmental risks of EtO, and the recent supply-demand imbalance of Cobalt-60 is also a cause for concern," the release said. "Viable alternatives such as e-beam sterilization are not as widespread in the U.S."
"We look forward to completing the construction of our new site over the coming months and to commissioning the facility in 2025," Leonard Zuba, general manager of BGS US, said in the email. "The new site will allow us to offer sterilization processes using … e-beam technology, which is essential for a wide range of single-use plastic medical devices."
"Our focus is on the quality and safety of our customers' products," Zuba said. "We rely on electron beam radiation to ensure reliable, efficient and environmentally friendly sterilization.
"Sterilization with ionizing radiation is one of the most common technologies for sterilizing medical devices, pharmaceutical primary packaging and biotech products," Zuba said. "My goal as general manager of BGS US is to position e-beam as a highly efficient sterilization method for U.S. manufacturers."
In the long term," Prinz said, BGS US will create about 40 jobs in operations and administration, including positions as machine operators, maintenance technicians, logistics personnel, and specialists in applications development, quality management and quality assurance.
BGS' investment in the new operation is "is in the mid-double digit million range," Prinz said, adding that it's "the largest construction budget in the history of BGS."
The new facility will also be equipped with fully automated product handling systems.
"Interest from our international customers and the growing demand for e-beam technology have driven us to expand our presence into the American market," Ostrowicki said. "Our experience in the U.S. has been highly encouraging, with strong support from the authorities and efficient approval processes having allowed us to hit the ground running. We've gained positive momentum overall. Now, in addition to our established operations in Germany and Europe, we're focused on strengthening our position in key global medical technology markets."
Earlier this year, BGS invested in new laboratory and logistics space at its headquarters in Wiehl, adding 10,764 square feet and increased capacity for handling sterile products.
BGS provides sterilization for customers in Europe for the medical technology, biotech, pharmaceuticals, packaging, automotive, mechanical engineering, infrastructure, and electrical industries. It has German facilities in Wiehl, Bruchsal, and Saal a.d. Donau.