Sterilization and Packaging Development: The Chicken and Egg Dilemma 

Sterilization modalities and medical device packaging are deeply interdependent decisions that should be evaluated together from the earliest stages of product development. This white paper examines how ethylene oxide and radiation sterilization processes can influence sterile barrier system performance, while also showing how packaging design can affect sterilization efficacy and process robustness. By addressing sterilization and packaging as connected design inputs rather than sequential afterthoughts, manufacturers can reduce technical, regulatory, commercialization risks and costs.

Presented by Logan Luke, Senior Expert Consultant, Nelson Labs

Logan has worked at Nelson Labs since 2018. He has worked in the sterilization, microbial IDs, and packaging departments. He has extensive knowledge in the packaging section and has aided many customers with their package-testing needs, from the benchtop to troubleshooting and validation design. He is well versed in a broad spectrum of packaging tests, from lot release package testing for pharmaceutical products to full package validations, including shipping and distribution and aging.

Logan graduated from Brigham Young University with a bachelor’s degree in microbiology. By actively participating in the development of guidance documents and standards as a member of the American Association of Medical Instrumentation (AAMI) and the American Standard Test Methods (ASTM), he has remained up to date with the current industry recommendations. He is also a member of the Parenteral Drug Association (PDA) and has expertise in container closure integrity and parenteral-product packaging functionality.

And Jean-Francois (Jeff) Zeevaert, Principal Scientist Gas Sterilization, Sterigenics

Jean-François (Jeff) Zeevaert is a Principal Scientist at Sterigenics. Jeff is responsible for the global oversight of gas sterilization process development & validation, systems improvement, and people mentoring. Before this role, Jeff has been working in various positions such as global leader for the 3Rs of EO Sterilization (EO reduction program) and Validation Engineer at the Sterigenics EO plant located in Verviers (Belgium). Jeff has a BSc in Biotechnology, has strong experience in Ethylene Oxide sterilization, and is considered an expert in EO sterilization validation, cycle development, cycle optimization, and failure investigations. He is also a member of ISO Technical Committees 194 and 198.

Followed by a live question and answer session

Sponsored by Nelson Labs and Sterigenics

About Nelson Labs

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 3,000 customers across 13 facilities in the United States, Mexico, Asia, and Europe. We provide our customers with mission-critical testing services, which assess the quality, effectiveness, and end-to-end sterility of products and, ultimately, the impact of the products on patient safety. These services are necessary for our customers’ regulatory approvals, product releases, and ongoing product performance evaluations. We have over 900 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety, and quality assurance. Pharmaceutical lab testing services include microbiology, biocompatibility and toxicology assessments, extractables and leachables evaluations of pharmaceutical containers, sterilization validation, sterility assurance, packaging validation and distribution simulation, and facility and process validation. We also provide expert advisory services to help customers navigate the regulatory requirements applicable throughout their product’s lifecycle. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.

About Sterigenics:  

Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical/biopharma, food safety and advanced applications markets. With our industry recognized scientific and technological expertise we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 48 global facilities that span 13 countries, we offer our customers a complete range of outsourced terminal sterilization services, primarily using the three major sterilization technologies: gamma irradiation, ethylene oxide processing and electron beam irradiation as well as nitrogen dioxide sterilization and x-ray irradiation. We are committed to addressing the growing need for sterilization in many parts of the world and partnering with our customers to eliminate threats to human health.