EtO, E-Beam & Gamma Sterilization Services.
Overview
What do we offer?
AMT offers validated sterilization services as part of our turnkey solution. Method selection and validation are critical: each technology (EtO or E-Beam) has advantages, limitations, and unique validation requirements. AMT designs and executes sterilization protocols following international standards (ISO 11135 for EtO, ISO 11137 for E-Beam), maintaining full documentation that supports regulatory approval and product release.
Overview
EtO — Ethylene Oxide (ISO 11135)
EtO sterilization is widely used for heat- and moisture-sensitive products or packaging that cannot withstand high temperatures. AMT will implement this service (Q3 2026) under ISO 11135, with controlled, validated processes that ensure microbial efficacy and safe residuals.
Capabilities & Competencies
Operational process
Load preparation
Validated configuration and packaging compatibility to guarantee gas penetration.
Preconditioning
Controlled temperature and humidity to optimize interaction with microbial load.
EtO exposure
Validated cycles including impregnation and exposure phases; continuous monitoring of critical parameters.
Aeration/desorption
Prolonged phases to eliminate residual EtO from products and packaging.
Verification
Biological and chemical indicators, microbiological testing, and residual analysis confirm compliance.
Documentation
Validation protocols, cycle records, final protocol reports, and certificates of sterilization by lot.
Overview
Validation activities (ISO 11135)
Microbial testing and Process Challenge Device (PCD) studies.
Cycle development: preconditioning, exposure, aeration.
Residuals testing and material compatibility assessments.
Load configuration and distribution validation.
Final protocol report with full data and conclusions.
Safety and environmental considerations
Emission abatement and neutralization systems.
Operator training in safe gas handling and incident response.
Electron beam irradiation is a fast, residue-free sterilization method ideal for many devices and polymer packaging. AMT partners with specialized providers to deliver E-Beam sterilization following ISO 11137.
A cutting-edge technology that uses high-energy electrons to destroy the nucleic acids (DNA) of microorganisms on medical devices and packaging.
E-beam sterilization offers several key advantages for medical device manufacturers. As a fast and efficient method, it delivers precise doses of high-energy electrons, ensuring thorough sterilization while maintaining product integrity. Unlike other methods, e-beam sterilization does not rely on chemicals or prolonged exposure times, making it an environmentally friendly option. It is ideal for high-volume production due to its quick cycle times and ability to be conducted at room temperature, minimizing thermal stress on sensitive materials. Additionally, e-beam technology provides consistent and repeatable results, supports the sterility assurance levels required for medical devices, and facilitates real-time processing without lengthy quarantines, reducing overall time-to-market.
Overview
E-Beam — Electron Beam (ISO 11137).
Overview
Gamma Radiation Sterilization – (ISO 11137) .
Gamma sterilization is offered as an integrated element of our contract-manufacturing services, providing a high-throughput, residue-free option for terminal sterilization of medical devices.
Sterilization cycles are validated to ISO 11137, and we provide comprehensive dose-mapping and traceable dosimetry to document absorbed doses across representative load configurations. Clients receive full sterilization records, dosimetry reports, dose-mapping data integrated into the device release package and technical file to support regulatory submissions. The service is scalable from pilot runs to production volumes and is managed end-to-end to align sterilization output with your manufacturing and quality processes.
Capabilities & Competencies
Operational process
Load preparation
Validated geometry to optimize dose distribution.
Irradiation
High-energy electron exposure damages microbial DNA, achieving the required reduction.
Dosimetry and dose mapping
Confirm minimum dose thresholds and maximum limits are met throughout the load.
Post-process inspection
Evaluation of material effects (e.g., embrittlement, crosslinking).
Automated inspection
AOI for surface defects; X-ray inspection (AXI) for hidden joints (BGA, µBGA); in-circuit and functional electrical testing.
Rework and verification
Controlled heat rework stations; validated repair processes to ensure reworkability without damaging boards.
Documentation
full validation protocol and dose audit reports.
Overview
Validation activities (ISO 11137)
Dose validation and audits.
Maximum/minimum dose testing.
Dose mapping and dosimetry.
Sterilization performance and crosslinking evaluation.
Consultative approach to sterilization
AMT does not impose a single sterilization method: we evaluate each product, material, packaging, and regulatory requirement to recommend the optimal sterilization route. Our service includes full validation management (IQ/OQ/PQ), microbiological and residuals testing, and comprehensive reporting to support regulatory submissions and product release.
Our Certifications.
Alliance Medical Technologies is majority owned and supported by a global partner with decades of industry experience and a workforce of thousands around the world. This strategic backing provides the financial strength, technical capability, and operational scale to deliver reliable, compliant, and cost efficient manufacturing services; helping our clients move from design to commercial production with confidence.