BGS US 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) sterilisation facility in Imperial, PA. The facility will begin operations in mid-2025.
BGS
The cerificaion audit was conducted by DQS Medizinprodukte from 7-10th January, 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,” said Leonard Zuba, general manager, BGS US. “It also keeps us on schedule to begin operations as planned.”
About the Certifications
ISO 13485 is a globally recognised 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 sterilisation 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 Sterilisation?
For decades, ethylene oxide (EtO) sterilisation has been the preferred sterilisation 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 sterilisation, have threatened domestic sterilisation capacity. Technologies such as E-Beam sterilisation that use concentrated beams of electrons to sterilise 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 sterilisation facilities of its kind.