Sterigenics
Sterigenics International LLC
★★★★★
3.0
/ 5
•
124 reviews
Sterigenics is a global leader in sterilization solutions for medical devices, pharmaceuticals, and other industries. They offer expertise in Gamma, Ethylene Oxide, E-Beam, and X-ray sterilization across 48 facilities worldwide.
Sterigenics is a global leader in comprehensive sterilization solutions, serving the medical device, pharmaceutical, advanced applications, commercial, and food industries. With a network of 48 facilities in 13 countries, they provide flexible and redundant contract sterilization services. Their team of over 1,600 engineers, scientists, and specialists brings more than 90 years of deep expertise in Gamma, Ethylene Oxide, Electron Beam, and X-ray sterilization technologies. As a business unit of Sotera Health, Sterigenics is committed to safeguarding global health by ensuring product safety and process integrity from conception to commercialization. They offer best-in-class, in-house expertise in engineering, regulatory, and EH&S, ensuring consistent quality and reliability. Sterigenics continuously invests in innovation and global expansion to meet growing customer demand for sterilization capacity.
About
**Sterigenics** is a global leader in sterilization solutions, offering expertise across multiple industries including medical devices and pharmaceuticals. They provide a comprehensive range of sterilization technologies, serving clients worldwide.
**Expertise & Scope**
* Specializes in Gamma, Ethylene Oxide (EO), E-Beam, and X-ray sterilization methods.
* Offers Noxilizer (NO2 Sterilizer) technology.
* Operates 48 facilities globally.
* Provides resources on sterilization dose audits and validation processes, particularly for Ethylene Oxide sterilization.
**Reputation / Proof Points**
* Operates 48 facilities worldwide.
**Expertise & Scope**
* Specializes in Gamma, Ethylene Oxide (EO), E-Beam, and X-ray sterilization methods.
* Offers Noxilizer (NO2 Sterilizer) technology.
* Operates 48 facilities globally.
* Provides resources on sterilization dose audits and validation processes, particularly for Ethylene Oxide sterilization.
**Reputation / Proof Points**
* Operates 48 facilities worldwide.
Additional information
Sterigenics highlights the importance of process definition as a critical first step in validating an Ethylene Oxide (EO) sterilization process. Their resources, including webinars, delve into why this is a required component of validation. Buyers seeking sterilization services can leverage Sterigenics' extensive global network and technological capabilities, which span various radiation and gas-based sterilization methods.
Key Highlights
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Global leader in sterilization solutions for medical devices and pharmaceuticals.
Source
“Sterigenics is a global leader in sterilization solutions for medical devices, pharmaceuticals, and other industries.”
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Offers expertise in Gamma, Ethylene Oxide, E-Beam, and X-ray sterilization.
Source
“They offer expertise in Gamma, Ethylene Oxide, E-Beam, and X-ray sterilization across 48 facilities worldwide.”
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Operates 48 facilities worldwide.
Source
“They offer expertise in Gamma, Ethylene Oxide, E-Beam, and X-ray sterilization across 48 facilities worldwide.”
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Provides resources on Ethylene Oxide (EO) sterilization validation processes.
Source
“In this course, you will learn about the importance of process definition (fractional) work as a part of an Ethylene Oxide (EO) validation and why it is not only important but required.”
Certifications & Trust Signals
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Operates 48 facilities worldwide.
Source
“They offer expertise in Gamma, Ethylene Oxide, E-Beam, and X-ray sterilization across 48 facilities worldwide.”
Buyer Snapshot
Best for
- Companies requiring medical device and pharmaceutical sterilization
- Businesses needing expertise in Gamma, Ethylene Oxide, E-Beam, and X-ray sterilization
How engagement typically works
- Direct service engagement
- Leveraging global facility network
Typical deliverables
- Sterilization services
- Validation support
Good to know
- Best when specific sterilization technologies like Gamma, EO, E-Beam, or X-ray are required.
HQ:
Oak Brook, US
Languages:
English
Claim status:
Listed
Services & Capabilities
Sterilization + Microbiology Validation
Countries:
United States, Asia
Industries:
Medical Devices
Sterilization Methods Supported:
EtO (Ethylene Oxide), Gamma Radiation, E-Beam, X-Ray
Validation Types Offered:
Other
Microbiology Tests Offered:
Bioburden, Sterility, Environmental monitoring, Other
Standards Supported:
ISO 11135 (EtO), ISO 11137 (Radiation), ISO 11737-1 (Bioburden), ISO 11737-2 (Sterility)
GMP Compliant:
Yes
Glp Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Nda Support:
Yes
Regions Served:
Global
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
Ethylene Oxide, Gamma Radiation, Electron Beam, X-Ray, Noxilizer (NO2)
Validation Types Offered
Full validation (IQ/OQ/PQ)
Microbiology Tests Offered
N/A
Lead Time Band
N/A
Quote SLA
N/A
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
N/A
