ReqoData
Medical Devices & Life Sciences 2026Updated

List of FDA-Registered Contract Sterilization Facilities

Comprehensive directory of FDA-registered contract sterilization service providers offering EtO, gamma, e-beam, and X-ray sterilization for medical devices, pharmaceuticals, and biotech products.

Available Data Fields

Facility Name
FDA Registration Number
Location
Sterilization Methods
ISO Certifications
Industries Served
Contact Information
Capacity / Throughput
Validation Services
Regulatory Compliance

Data Preview

* Full data requires registration
Facility NameSterilization MethodsFDA Reg. Status
Sterigenics (Schaumburg, IL)EtO, Gamma, E-Beam, X-RayRegistered
STERIS AST (Spartanburg, SC)EtO, GammaRegistered
E-BEAM Services (Cranbury, NJ)E-BeamRegistered
Blue Line Sterilization (Modesto, CA)EtORegistered
SteriTek (Fremont, CA)E-Beam, X-RayRegistered

200+ records available for download.

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FDA-Registered Contract Sterilization: Finding the Right Partner

The FDA requires contract sterilizers that process medical devices and drugs to register as device establishments under Section 510 of the FD&C Act. This mandate, reinforced by the FDA Safety and Innovation Act (FDASIA), means every contract sterilization facility handling regulated products must maintain active FDA registration and listing.

Sterilization Modalities at a Glance

MethodMechanismBest ForKey Standard
Ethylene Oxide (EtO)Chemical gas diffusionHeat- and moisture-sensitive devicesISO 11135
Gamma IrradiationCobalt-60 photonsHigh-volume, dense packagingISO 11137
Electron Beam (E-Beam)Accelerated electronsFast turnaround, thin productsISO 11137
X-RayBremsstrahlung radiationDense loads, no isotope neededISO 11137

Regulatory Landscape

Contract sterilizers face a dual regulatory burden: FDA registration and EPA emission standards. The EPA’s 2024 final rule on ethylene oxide emissions under the National Emission Standards for Hazardous Air Pollutants (NESHAP) imposed stricter controls on EtO sterilization facilities, pushing some operators toward radiation-based alternatives. In July 2025, a White House executive order provided regulatory relief for certain stationary sources to protect the domestic medical supply chain.

Market Structure

The global contract sterilization market was valued at $5.24 billion in 2024 and is projected to reach $9.84 billion by 2031. North America hosts the largest concentration of FDA-registered facilities, led by three dominant networks:

Sterigenics (Sotera Health)
48 facilities across 13 countries, offering EtO, gamma, e-beam, and X-ray. The Fort Worth, TX facility is the largest gamma sterilization plant in their global network.
STERIS AST
50+ contract sterilization and laboratory facilities worldwide. Technology-neutral approach covering all major modalities.
E-BEAM Services
450+ kW of installed accelerator capacity across Ohio and New Jersey facilities, processing nearly one billion pounds of material annually.

Choosing a Contract Sterilizer

Key evaluation criteria for medical device manufacturers selecting a contract sterilization partner include:

  • Modality compatibility with your device’s material and packaging
  • Geographic proximity to minimize transit time and shipping costs
  • Turnaround time — e-beam can process in hours versus days for EtO
  • Validation support — dose mapping, bioburden testing, sterility assurance level (SAL) documentation
  • Regulatory track record — FDA inspection history and 483 observations

Frequently Asked Questions

Q.How does the data confirm a facility is FDA-registered?

Each facility record includes its FDA Establishment Identifier (FEI) number, verified against the FDA’s Establishment Registration and Listing database. Our AI crawls public FDA data sources at the time of your request to ensure current registration status.

Q.Can I filter by sterilization modality and location together?

Yes. You can combine filters such as “gamma irradiation facilities within 200 miles of Minneapolis” or “EtO sterilizers in the Southeast US with ISO 13485 certification.”

Q.Does this include facilities outside the United States?

The primary dataset focuses on FDA-registered facilities, which includes both domestic US facilities and foreign establishments registered with the FDA. You can filter by country or region.

Q.How current is the FDA registration status?

Registration status is verified from public FDA sources at the time of your request. The AI crawls the latest publicly available data rather than relying on a static database, so you get up-to-date registration information.