Sterilization. Done Right
Transparent. Reliable. Unwavering.
We help manufacturers make confident, compliant sterilization decisions, whether you're converting to a sustainable modality, validating a new process, or optimizing an existing program.
How We Help
We combine high-level regulatory strategy with complete operational management. By partnering with leading contract radiation and gas processing facilities, we design, manage, and execute full validation and processing programs, delivering a seamless, turnkey path from protocol design to audit-ready completion.
Modality Conversion
Strategy, evaluation, and execution of transitions to E-beam, X-ray, or Novel Gas, whether you're moving off EtO, Gamma, or exploring new options.
Process Validation & Dose Mapping
Designing and executing validation protocols to ISO 11137 & 11135, including dose mapping, dose audits, cycle development, PCD designs, and establishing sterilization doses.
Upskilling your teams on sterilization science, quality systems, and process ownership, from floor-level operators to leadership.
Training & Education
Supplier Qualification & Audits
Technical audits, sterilization assessments, and microbiology program evaluations for your contract sterilization partners or in-house facilities.
Supporting 510(k) sterilization sections, USDA compliance pathways, and international submissions with clear, defensible documentation.
Regulatory Strategy
Packaging & Material Optimization
Evaluating material and packaging design compatibility for radiation and novel gas processes, ensuring product integrity through sterilization.
Industries We Serve
We provide expert advisory services, protocol strategy, and regulatory guidance for teams navigating complex sterilization and bioburden requirements. From modality conversions to validation program design, we help technical leadership establish compliant, effective contamination control strategies across diverse sectors
Food & Agriculture
Pet Products
Consumer & Cosmetics
Laboratory & Life Sciences
Pharmaceutical & Biotechnology
Medical Devices
About TRU-BEAM
James McCoy has over 15 years of specialized experience in eBeam, X-ray, Gamma, EtO, and Novel Gas sterilization across medical devices, pharmaceuticals, food, and agriculture. Before founding TRU-BEAM, he served as the E-beam, X-ray, and Novel Gas SME at a global medtech company, with roots in research at Texas A&M's National Center for Electron Beam Research.
Get in Touch
Whether you have a question, an idea, or just want to say hello, feel free to reach out, we’re always here to help and look forward to hearing from you soon.