Quality Certifications Awarded to BGS US

BGS US has earned ISO 13485, ISO 9001 and ISO 11137 certifications for its 100,000-square-foot electron beam (E-beam) sterilization facility in Imperial, Pa., near Pittsburgh International Airport. The facility will begin operations in mid-2025.

The certification audit was conducted by DQS Medizinprodukte GmbH from Jan. 7-10, and verified that BGS US meets all requirements without any non-conformities. “This significant milestone marks a crucial step for our company and underscores our commitment to the highest levels of quality and customer satisfaction,” BGS US General Manager Leonard Zuba said. “It also keeps us on schedule to begin operations as planned.”

ISO 13485 is a globally recognized standard for medical device quality management systems, ensuring that products meet stringent safety and performance requirements. ISO 9001 is awarded to companies whose quality management system adheres to international best practices and supports operational efficiency and continuous improvement. ISO 11137, meanwhile, specifies requirements for the development, validation, and control of radiation sterilization processes that ensure the highest levels of safety and efficacy for medical devices.

To maintain certifications and ensure continuous improvement, BGS US will undergo annual compliance audits. The next one is scheduled for January 2026.

For decades, ethylene oxide (EtO) sterilization has been the preferred sterilization method of medical device manufacturers. In recent years, however, growing awareness of the environmental hazards associated with the technology, along with an increasingly difficult-to-obtain supply of Cobalt-60 for gamma sterilization, have threatened domestic sterilization capacity. Technologies such as E-beam sterilization that use concentrated beams of electrons to sterilize products are practical alternatives that can alleviate supply chain bottlenecks.

The technologies that BGS US will use in Pittsburgh have proven to be effective at the company’s three sites in Germany. BGS claims to be one of the pioneers in E-beam technology and operated one of the first E-beam sterilization facilities of its kind.

BGS US specializes in high-volume E-beam contract sterilization, offering precise, reliable, and sustainable sterilization services. As part of BGS Beta-Gamma-Service, a developer of radiation technology for more than 40 years, the company serves the medical device, pharmaceutical, and biotechnology industries. The company’s new state-of-the-art facility near Pittsburgh is designed to meet the highest industry standards and is equipped to handle large volumes. BGS US offers efficient sterilization solutions, helping clients bring their products to market faster.