Leading the Conversation: Cretex Medical | QTS at the 2026 Fermilab Medical Device Sterilization Workshop

Sopheak Srun of Cretex Medical | QTS leads discussion on sterilization modalities and solutions for medtech companies at the Medical Device Sterilization Workshop at Fermilab.

by Sopheak Srun | September 30, 2026

Sopheak Srun, Principal Sterilization Scientist at Cretex Medical | QTS, was one of the leading experts who spoke at the conference about strategies to address the critical capacity issues impacting Gamma and Ethelyne Oxide (EO) sterilization modalities.

The medical device industry is at a critical crossroads. For decades, we have relied on two primary sterilization pillars: gamma irradiation and ethylene oxide (EO). Today, both modalities face unprecedented supply and capacity pressures that threaten global supply chain resilience.

The projected global supply of Cobalt-60 (essential for gamma sterilization) is not expected to keep pace with the growing demand. This has prompted a concerted industry-wide effort to dismantle technical and regulatory barriers to adopting accelerator-based radiation alternatives, particularly X-ray and electron beam (E-beam). Compounding these pressures, EO sterilization has experienced acute capacity constraints driven by facility shutdowns and heightened regulatory scrutiny surrounding airborne emissions. This has sparked an urgent push to optimize cycle efficiencies and reduce the industry’s overall dependence on EO.

The Fermilab Medical Device Sterilization Workshop held its annual hybrid forum at Fermilab on September 9 and10, 2026. It was an opportunity to create cross-functional alignment across the entire healthcare ecosystem to address these challenges.

Sopheak Srun The event convened 259 registered participants, including medical device manufacturers, accelerator producers, contract sterilizers, testing laboratories, and FDA staff. Attendees gathered to examine the current science of radiation sterilization (X-ray, gamma, and E-beam), evaluate alternative technologies, interface directly with regulators, and build partnerships to secure future sterilization capacity.

Cretex Medical | QTS was front and center. Sopheak Srun, MPH, SM(NRCM), CISS-EO, CISS-RAD, Principal Sterilization Scientist at Cretex Medical | QTS, contributed across two core sessions to share Cretex’s technical expertise, foster regulatory dialogue, and highlight practical solutions for modern device manufacturing.

Advancing the Science: Alternative SALs and Difficult-to-Sterilize Products

As the industry explores new sterilization modalities and develops more advanced combination products, drug-delivery devices, and bioresorbable implants, companies increasingly find that traditional terminal processing to achieve a standard 10-6 Sterility Assurance Level (SAL) can damage sensitive materials.

Sopoheak’s featured presentation, “Alternative Sterility Assurance Levels (SALs): Current State, Future Direction, and Ongoing Debate,” explored the path forward when achieving a 10-6 SAL compromises product safety or efficacy:

Challenging the 10-6 SAL Paradigm: The 10-6 SAL target originated from the food canning industry's early 20th-century "12-D concept" for Clostridium botulinum and the 1970s large-volume parenteral pharmaceutical guidelines. It was adopted by medtech as an engineering and risk convention rather than an absolute clinical requirement.
A Disciplined, Risk-Based Hierarchy: Navigating standards and guidance documents such as AAMI ST67 and ISO/TS 19930, Sopheak outlined the rigorous gateway criteria required before an alternative SAL (such as 10-4) can be considered. Manufacturers must first prove that all reasonably practicable mitigations have been exhausted. Those include material substitutions, package redesign to improve sterilant penetration or dose uniformity, modality switches (such as transitioning to E-beam or X-ray), and moving from overkill validation to bioburden-based methods (e.g., radiation Method 2).
The Imperative for Industry Data Sharing: Sopheak challenged the community to overcome competitive hesitations and regulatory sensitivities by publishing anonymized case studies and post-market surveillance linking SAL decisions to clinical outcomes.

Sopheak further expanded on this philosophy during an interactive panel on the Validation of Difficult-to-Sterilize Products, collaborating directly with leaders from the FDA, Nelson Labs, Johnson & Johnson, and LifeNet Health to outline practical pathways for challenging device architectures.

Packaging & Sterilization: Commercial Solutions in Practice

Packaging and sterilization go hand-in-hand, as packaging designs directly impact sterilant delivery/dose distribution, and sterilization can impact sterile barrier integrity and packaging performance. During the workshop’s Packaging Panel, Sopheak joined industry peers from DuPont and Canyon Labs to discuss the criticality of having packaging engineers work together with professionals in sterilization to be able to meet these evolving challenges. He highlighted how QTS bridges package design and sterilization science under one roof to de-risk customer programs:

QSEAL® Pre-Validated Packaging: QTS customers utilize QTS’s pre-validated tray and pouch families to bypass months of custom tooling, design iterations, and seal qualification testing, dramatically reducing time-to-market.
QSTERILE® Pre-Validated EO Processing: By pairing standardized packaging with pre-validated ethylene oxide cycles, QTS helps device developers optimize cycle efficiency and avoid costly, months-long cycle development timelines.
Worst-Case Sterilization Testing: To ensure true safety margins across a product's shelf life, QTS evaluates sterile barrier systems under worst-case challenge cycles rather than nominal parameters, verifying that package integrity holds up under rigorous processing conditions. However, the worst-case conditions used under these pre-validated offerings might not always be considered worst-case for every type of product that is adopted under these programs. As a result, this has to be assessed with a justification documented for every new product that gets adopted, and it is critical for this to be done by competent individuals with the right expertise.

The Cretex Advantage: Why External Collaboration Matters

Active engagement in industry associations, standards committees, and forums like the Fermilab Medical Device Sterilization Workshop ensures that Cretex Medical does not merely react to industry disruptions. We are helping to shape the solutions. Direct collaboration with regulators, medical device companies, and technology innovators gives our teams early insight into emerging issues and industry trends.

More importantly, it provides our customers with immediate access to world-class technical mentorship. Whether navigating delicate biomaterials, transitioning from gamma to X-ray or E-beam, or seeking to compress commercial launch timelines, the combined expertise of QTS and Cretex Medical ensures our partners build compliant, robust, and future-proof pathways from day one.

Sopheak Fermilab (1)