Sterigenics, a Sotera Health Company Gamma Irradiation Technology for Sterilization of APIs and Drug Formulations

Sterigenics is a global leader in comprehensive sterilization solutions and expert advisory services, providing mission-critical and government-mandated sterilization services for more than 90 years across gamma, ethylene oxide (EO), electronic beam (E-Beam) and X-Ray technologies.

With applications ranging from pharmaceutical drug products to medical device sterilization, these technologies are suitable for sterilization, microbial reduction and material modification.

Sterigenics is a business unit of Sotera Health along with Nordion® and Nelson Labs®. Together, these companies are world-leading, fully integrated protectors of global health, touching the lives of more than 180 million people around the world each year.

Pharmaceutical sterilization and sterility assurance

Sterigenics aims to develop and maintain the most effective sterilization processes for its pharmaceutical clients’ products, bringing them to market in the fastest, most efficient and safest way possible.

Sterigenics also offers sterilization across a number of other industries, including, medical device, food, commercial products, packaging and advanced radiation processing.

Radiation-based gamma sterilization

Sterigenics’ radiation-based gamma sterilization solution offers a wide range of polymer compatibility with some limitations due to oxidation effects.

Products can be shipped to the final user as soon as they exit the gamma irradiation facility.

Applications of gamma sterilization include:

  • Irradiation of ambient and frozen tissues
  • Non-proliferation by irradiation to stop cell growth in vaccine production
  • Decontamination of bio-hazard type products such as human serum
  • Virus removal from blood, serums, or other biologic products such as frozen products that require irradiation under cold chain management
  • Sterilization or decontamination of bulk active pharmaceutical ingredients (API), excipients or ingredients
  • Sterilization of drug-device products
  • Sterilization of hydrogels
  • Final sterilization of pharmaceutical products such as API-filled vials or syringes, which can be powder-filled, a solution/suspension, or a gel/ointment

Ethylene oxide sterilization

EO offers a wide range of material compatibility, except for moisture and temperature-sensitive materials.

For manufacturers whose products are particularly radiation sensitive, EO can be an effective sterilization modality.

Applications of EO sterilisation include:

  • External sterilization of pre-filled syringes, vials or cartridges where the goal is that EO does not reach the pharmaceutical product
  • Sterilization of bulk API
  • Sterilization of drug-device products
  • DNA removal

Nitrogen Dioxide based Sterilization

Nitrogen Dioxide (NO2) based sterilization offers ultra-low temperatures, minimal pressure requirements, no cytotoxic residuals, and fast cycle times.

Applications of NO2–based sterilization includes external sterilization of pre-filled syringes, vials or cartridges where the goal is that NO2 does not reach the pharmaceutical product.

About Sterigenics

Sterigenics is a leading global provider of comprehensive sterilization solutions and expert consulting services, offering:

  • Safety and quality – The company offers best-in-class in-house expertise across engineering, regulatory, and environment health and safety (EH&S) to ensure consistent quality and reliability.
  • Global integrated network – Sterigenics’ operations span 47 facilities in 13 countries, providing the flexibility and redundancy to meet its clients’ contract sterilization needs.
  • Outstanding service – The company is driven to fulfill its customers’ needs in a timely fashion and with the highest quality and care, while providing innovative resources and support.
  • Industry-leading experts – Sterigenics has more than 1,600 engineers, scientists, safety specialists and solution providers with more than 90 years of across gamma, EO, E-beam, and X-ray sterilization.

Make an enquiry

Press Release

Sterigenics International and Noxilizer to provide NO2 sterilization

Noxilizer and Sterigenics International have announced the signing of a global agreement that will make Sterigenics the exclusive worldwide provider of nitrogen dioxide (NO2) contract sterilization services, as well as feasibility and research studies, to the pharmaceutical, biotech and medical device manufacturing industries.

White Papers

Dose Delivery Methodology by Sterigenics’ CompactCell

The Sterigenics CompactCell is a low-volume, high-precision irradiator designed to provide a higher precision dose than other commercially operated irradiators.

Address
Sterigenics, A Sotera Health Company

2015 Spring Road, Suite 650

Oak Brook, IL 60523

United States of America

+1 800 472 4508 www.sterigenics.com www.soterahealth.com www.nordion.com www.nelsonlabs.com

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Press Release

9 April 2019

Sterigenics has announced that it will be attending CPhI North America.

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30 January 2019

Sterigenics has announced that it will be attending Pharmapack, Paris. 

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4 December 2018

Sterigenics has announced that it is building a new facility in Markham Vale North in Chesterfield/Derbyshire, UK.

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18 July 2018

Sterigenics has announced that it is building a new facility in Markham Vale North in Chesterfield/Derbyshire, UK.

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31 October 2017

Sterigenics International has announced that it has acquired Toxikon Europe, the European division of Toxikon Corporation.

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3 October 2017

Noxilizer and Sterigenics International have announced the signing of a global agreement that will make Sterigenics the exclusive worldwide provider of nitrogen dioxide (NO2) contract sterilization services, as well as feasibility and research studies, to the pharmaceutical, biotech and medical device manufacturing industries.

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7 April 2015

Sterigenics will be attending Interphex 2015 from 21-23 April at Javits Center in New York.

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30 October 2014

Sterigenics International has announced its acquisition of Gammarad, Italy's leading gamma sterilisation provider.

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3 October 2014

Niki Fidopiastis, SteriPro's consulting director, will serve as a trainer at the Radiation Sterilization for Medical Devices Training Programme from October 7-10 2014 in Alexandria, VA.

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6 August 2014

Sterigenics International has announced it has completed the $826m acquisition of Nordion Inc.

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15 July 2014

Sterigenics International has announced that it received ISO / IEC 17025:2005 food and chemistry accreditation in Mexico.

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19 June 2014

Sterigenics has announced it will invest more than $10m to expand operations in Atlanta, Dallas and Belgium.

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27 March 2014

Sterigenics has entered into a definitive agreement to acquire Nordion Inc.

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6 March 2014

Sterigenics International has announced it has closed the acquisition of Food Technology Service Inc.

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Regional Offices

Sterigenics, A Sotera Health Company

2015 Spring Road, Suite 650

Oak Brook, IL 60523

United States of America

+1 800 472 4508 www.sterigenics.com www.soterahealth.com www.nordion.com www.nelsonlabs.com
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