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.