Imperial, PA, March 6, 2025 – BGS US, a global leader in radiation sterilization for medical devices, pharmaceutical packaging, and biotechnology products, recently acquired quality certifications for ISO 13485 and ISO 9001, and the confirmation of ISO 11137 for its 100,000-square-foot Electron Beam (E-Beam) sterilization facility in Imperial, PA, near the Pittsburgh International Airport. The facility will begin operations in mid-2025.
The certification audit was conducted by DQS Medizinprodukte GmbH from January 7-10, 2025, 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,” says Leonard Zuba, General Manager, BGS US. “It also keeps us on schedule to begin operations as planned.”
Leonard Zuba, General Manager of BGS US, leads the company’s new 100,000-square-foot sterilization facility in Imperial, PA. BGS recently obtained the quality certification ISO 13485, ISO 9001, and the confirmation of ISO 11137 for the site to ensure compliance with global sterilization standards.
About the Certifications
- ISO 13485 is a globally recognized standard for medical device quality management systems, ensuring that products meet stringent safety and performance requirements.
- ISO 9001 confirms that a company’s quality management system adheres to international best practices and supports operational efficiency and continuous improvement.
- ISO 11137 specifies requirements for the development, validation, and control of radiation sterilization processes that ensure the highest levels of safety and efficacy for the use of medical devices.
To maintain certifications and ensure continuous improvement, BGS US will undergo annual compliance audits. The next one is scheduled for January 2026.
Why Use E-Beam Sterilization?
For decades, ethylene oxide (EtO) sterilization has been the preferred sterilization method of medical device manufacturers. In recent years, 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 is one of the pioneers in the use of E-Beam technology and operated one of the first E-Beam sterilization facilities of its kind.
About BGS US
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 global leader in radiation technology for over 40 years, the company serves the medical device, pharmaceutical, and biotechnology industries.
The 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 and with uncompromised quality. More information about BGS US’s quality management and certifications can be found here.
For more information, contact Lena Prinz, BGS US, at prinz@bgs-us.com or visit…