Sterigenics
Sterigenics International LLC
★★★★★
3.0
/ 5
•
122 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
**Who they are**
Sterigenics is a global leader in sterilization solutions, offering expertise across various industries including medical devices and pharmaceuticals. They operate a significant network of facilities worldwide.
**Expertise & scope**
* Specializes in Gamma, Ethylene Oxide (EO), E-Beam, and X-ray sterilization methods.
* Provides sterilization solutions for medical devices, pharmaceuticals, and other industries.
* Offers resources on understanding radiation methods for dose establishments and the importance of sterilization dose audits.
* Features webinars on topics such as the validation of EO sterilization processes, emphasizing process definition.
**Reputation / proof points**
* Operates 48 facilities worldwide.
Sterigenics is a global leader in sterilization solutions, offering expertise across various industries including medical devices and pharmaceuticals. They operate a significant network of facilities worldwide.
**Expertise & scope**
* Specializes in Gamma, Ethylene Oxide (EO), E-Beam, and X-ray sterilization methods.
* Provides sterilization solutions for medical devices, pharmaceuticals, and other industries.
* Offers resources on understanding radiation methods for dose establishments and the importance of sterilization dose audits.
* Features webinars on topics such as the validation of EO sterilization processes, emphasizing process definition.
**Reputation / proof points**
* Operates 48 facilities worldwide.
Additional information
Sterigenics provides specialized sterilization services, including Ethylene Oxide (EO) validation. Their resources highlight the importance of process definition as a critical first step in EO validation, emphasizing that this is a required component. Buyers interested in EO sterilization processes can find detailed information and resources related to validation requirements.
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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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 sterilization validation, including EO process validation webinars.
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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Part of Sotera Health, which includes Nelson Labs and Sotera Health Academy.
Source
“Sotera Health Nelson Labs Sterigenics Sotera Health Academy”
Buyer Snapshot
Best for
- Companies requiring sterilization services for medical devices and pharmaceuticals.
- Organizations seeking expertise in Gamma, Ethylene Oxide, E-Beam, and X-ray sterilization.
How engagement typically works
- Direct service engagement for sterilization needs.
- Access to educational resources like webinars for process understanding.
Typical deliverables
- Sterilization of medical devices.
- Sterilization of pharmaceutical products.
- Expert consultation on sterilization validation.
Good to know
- Best when specific sterilization technologies like Gamma, EO, E-Beam, or X-Ray are required.
HQ:
Oak Brook, US
Languages:
English
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, Bacterial Endotoxin (LAL), Environmental monitoring
Standards Supported:
ISO 11135 (EtO), ISO 11137 (Radiation)
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 Sterilization, Gamma Sterilization, Electron Beam Sterilization, X-Ray Sterilization, Noxilizer (NO 2 Sterilizer)
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
