Sotera Health Company provides end-to-end sterilization solutions, lab testing and advisory services for the healthcare industry.
The company provides end-to-end sterilization, as well as microbiological and analytical lab testing and advisory services to help ensure that medical, pharmaceutical and food products are safe for healthcare practitioners, patients and consumers in the United States and around the world. The company’s customers include over 40 of the top 50 medical device companies...
Sotera Health Company provides end-to-end sterilization solutions, lab testing and advisory services for the healthcare industry.
The company provides end-to-end sterilization, as well as microbiological and analytical lab testing and advisory services to help ensure that medical, pharmaceutical and food products are safe for healthcare practitioners, patients and consumers in the United States and around the world. The company’s customers include over 40 of the top 50 medical device companies and nine of the top ten global pharmaceutical companies. The company’s services are an essential aspect of the company’s customer’s manufacturing processes and supply chains, helping to ensure sterilized medical products reach healthcare practitioners and patients. Most of the company’s services are necessary for the company’s customers to satisfy applicable government requirements.
The company is a trusted partner to approximately 5,000 customers in over 50 countries. The company gives its customers confidence that their products meet regulatory, safety and effectiveness requirements. With the company’s industry-recognized scientific and technological expertise, the company helps promote the safety of millions of patients and healthcare practitioners around the world.
Businesses
Sterilization Services
The company’s sterilization services business is consisted of Sterigenics and Nordion.
Sterigenics
The company provides outsourced terminal sterilization and irradiation services. The company offers a globally integrated platform for its customers in the medical device, pharmaceutical, food safety, and advanced applications markets, with facilities strategically located to be convenient to its customers’ manufacturing sites or distribution hubs.
Terminal sterilization is the process of sterilizing a product in its final packaging; it is an essential, and often government-mandated, last step in the manufacturing process of healthcare products before they are shipped to end-users. The products that the company sterilizes include procedure kits and trays, implants, syringes, catheters, wound care products, medical protective barriers, including personal protective equipment (‘PPE’), laboratory products and pharmaceuticals.
Sterilization Services
The company offers its customers a complete range of terminal sterilization services, primarily using the three major commercial terminal sterilization technologies: gamma irradiation, EO processing and E-beam irradiation. The company continues to invest in and develop its capabilities and its methods of sterilization and it continues to explore new alternative modalities and technologies.
The company provides gamma irradiation services at 23 of its facilities, EO processing services at 17 of its facilities and electron beam (‘E-beam’) irradiation services at eight of its facilities.
The company also invests in alternative modalities to serve its customers. X-ray irradiation is a process in which products, such as medical devices and lab ware are exposed to machine-generated radiation in the form of X-rays for the purpose of sterilization and decontamination. X-rays are similar in performance to gamma rays and are useful for processing certain materials by virtue of the high penetration capabilities of X-ray. The company utilizes X-ray irradiation at one of its sterilization facilities for bio-hazard reduction for the United States Postal Service, or USPS. The company is also investing in NO2-based sterilization, which has been effective in sterilizing of prefilled syringes, drug-device combination products and custom implants.
Sterilization Applications
Sterigenics primarily provides sterilization services for medical device manufacturers and the pharmaceutical industry. Sterigenics also provides decontamination services for the food industry. Additionally, Sterigenics provides various advanced applications for other organizations and companies, including the USPS and semiconductor manufacturers. The company’s customers select the sterilization method that meets the needs of their products and requirements of regulators and the company delivers sterilization services according to their customer-specific protocols. In most cases, customers are serviced from more than one facility.
Medical device sterilization. Medical device sterilization is a regulatory requirement in many jurisdictions and an important and last step in the manufacturing of healthcare products, such as medical protective barriers, including PPE, procedure kits and trays, implants, syringes, catheters and wound care products. A broad range of single use, prepackaged medical products, as well as certain consumer products, are required by government regulations to be sterile, or meet certain acceptable microbial levels when sold. These products are not manufactured in a ‘sterile’ or ‘clean’ environment and are thereby inhabited by potentially harmful microbes. Products must therefore be treated before shipment, either in-house by the manufacturer or by an outsourced sterilization provider, such as Sterigenics.
The company has developed a consultative approach with medical device manufacturers that expands the company’s service offerings beyond core product sterilization, The company offers customers a comprehensive selection of advisory services in design, testing, production and supply chain management for sterile healthcare products before, during and after the sterilization process to ensure and improve a product’s speed to market and compliance with regulatory requirements.
Pharmaceuticals. The company provides comprehensive outsourced terminal sterilization solutions to help its customers in the pharmaceutical industry meet regulatory requirements. The company’s sterilization expertise covers a variety of pharmaceutical drug products, such as active pharmaceutical ingredients, pre-filled syringes, drug components, excipients and primary packaging and components.
In addition, pharmaceutical companies are starting to market disposable delivery devices, such as auto-inject devices for epinephrine, which are combined medical device and pharmaceutical products. As these disposable delivery devices are subject to both medical device regulations and pharmaceutical regulations. The company can provide a full suite of services across the company to help its customers throughout key stages in the lifecycle of these complex products.
Food and agricultural products. The company provides microbial reduction and microbial remediation services for food and agricultural products. Generally, in a microbial reduction process, products are exposed to lower levels of treatment than in a sterilization process. In connection with the company’s microbial reduction services, the company treats a wide array of products, such as spices, herbs, animal feed and food packaging materials to address safety concerns of customers and consumers or to extend shelf life. The company irradiates a variety of food and food packaging products, ranging from orange juice to steaks, to guard against harmful bacteria, such as listeria, salmonella, E. coli and other pathogens. Microbial reduction and irradiation offer producers and processors a method to safeguard against bacteria from the time of the packaging of their products to the time they reach consumers. The company also provides microbial remediation services that stop the progression of damage to products and help make the products safe for distribution.
Commercial, advanced and specialty applications. The company provides a wide range of advanced applications services for industrial materials to customers that use ionizing radiation to modify materials or products. The advanced applications sterilization industry is consisted of a large number of distinct segments that can be addressed using the company’s services for radiation processing. Materials that undergo advanced application processes include products, such as power semiconductors, polymers and gemstones. In addition, the company utilizes its ionizing radiation services to provide bio-security services to the USPS by treating and protecting the mail against unwanted pathogens and biohazards. In Canada and Europe, where recreational cannabis, medical cannabis, or both, are legal, the company provides commercial gamma and E-beam irradiation services for decontamination of cannabis.
Sterigenics Customers
In 2024, Sterigenics serves more than 2,000 customers. The company follows extensive validation procedures with its customers to determine the optimal sterilization method for each product, and to validate that the chosen method will achieve the sterility requirement for that product. Once a sterilization process has been validated, the company adheres to its customers’ process specifications to treat their product.
Although sterilization services are an essential element in the company’s customers’ manufacturing processes, they generally represent a small fraction of the total end-product medical devices.
For many products, the company’s customers are required to include the specific chamber or chambers at which the product was validated to validate a product’s listing in the Food and Drug Administration (‘FDA’) (or foreign equivalent) product registration and are typically required to re-register if they switch facilities, which makes switching locations for a particular product a difficult and expensive process for the company’s customers. This dynamic contributes to low customer churn and long-term relationships.
In addition, Sterigenics has achieved high historical customer retention and renewal rates—Sterigenics has 100% renewal rates of its top ten customers for more than five consecutive years, and an average tenure of over a decade with its top 25 customers over the last five years—and minimal customer concentration. The company has also introduced advanced processing systems for outsourced sterilization that are designed to enhance operating efficiencies, improve turnaround times and provide for greater processing flexibility without sacrificing quality, consistency or reliability. More than 90% of Sterigenics’ revenues for the year ended December 31, 2024, were from customers under multi-year contracts.
Sterigenics Competition
The company compete globally with Applied Sterilization Technologies, a segment of STERIS plc, as well as other smaller or regional outsourced sterilization companies.
Sterigenics Suppliers
Sterigenics primarily purchases its supply of Co-60 sources, the key input into the gamma sterilization process, from Nordion. The company’s supply of Co-60 sources is at times impacted by the global availability of Co-60. The company’s supply of EO is sourced from various suppliers around the world.
Sterigenics Facilities
With 48 facilities in 13 countries, the company’s global network of sterilization facilities represents a significant competitive advantage. The company serves many of its sterilization customers at more than one facility, with approximately 80% of Sterigenics’ net revenues attributable to customers using more than one of the company’s facilities and more than 50% of Sterigenics’ net revenues attributable to customers using five or more of the company’s facilities in 2024.
The company’s global facility network, built and expanded over several decades, is strategically located convenient to customers’ manufacturing sites and distribution hubs or routes. For many of the company’s customers, the location of the company’s facilities is important because transportation and logistics costs can be meaningful. The company also employs proprietary technology to provide customers with increased visibility into the company’s processes. Sterigenics GPS enables customers to monitor the sterilization process in real-time and better manage their supply chain. These features improve the accuracy and visibility of customer order information and quality data, which in turn provide enhanced transparency to regulatory agencies around the world, further enhancing the company’s reputation as a company with regulatory expertise. The company is focused on continuing to leverage advanced technology and service offerings to better serve customers.
Nordion
Nordion is the global provider of Co-60 used in the sterilization and irradiation processes for the medical device, pharmaceutical, food safety, and high-performance materials industries, as well as in the treatment of cancer. Co-60 is a radioactive isotope that emits gamma radiation that sterilizes items by killing contaminating micro-organisms. In addition, Nordion is a leading global provider of gamma irradiation systems, which are the units that house the Co-60 sources within a gamma sterilization facility. The company estimates that gamma sterilization, which is a critical component of the global infection control supply chain, accounts for approximately 30% of single-use medical device sterilization worldwide. Nordion’s customers include outsourced contract sterilizers, including Sterigenics, medical device manufacturers that sterilize their products in-house and other specialized medical device manufacturers. Approximately 90% of Nordion’s revenues for the year ended December 31, 2024, were from customers under multi-year contracts.
The company provides its customers with high quality, reliable, safe and secure Co-60 source supply at each stage of the source’s life cycle. The company supports its customers with handling and processing of Co-60, recycling of depleted sources and global logistics enabled by the company’s licensed container fleet. The company also provides regulatory and technical service expertise to improve the risk profiles and enhance effectiveness of gamma processing operations. Without this radioactive material, gamma sterilization would not be possible on the global scale at which it is used today. The company is integral to its customers’ operations due to highly coordinated and complex installation processes.
Nordion designs, installs and maintains gamma irradiation systems. Nordion developed the first Co-60 based tele-therapy unit for cancer treatment in 1951 and the first panoramic irradiator in 1964. In addition to selling Co-60 sources for sterilization purposes, Nordion also sells high specific activity Co-60 (‘HSA Co-60’ or ‘medical Co-60’) used in stereotactic radiosurgery as a radiation source for oncology applications, specifically in Gamma Knife and other similar applications. Today, Co-60 is a critical part of treatment for brain and other cancers because it is noninvasive, reliable, effective and safe to use.
Co-60 Production Process
Nordion’s primary product is Co-60 sources. Co-60 is a radioactive isotope used in radiation sterilization that decays naturally at a rate of approximately 12% annually. Co-60 is produced by placing cobalt-59 (‘Co-59’), the most common form of cobalt, into a nuclear power reactor to be activated.
The Co-60 production process requires high purity Co-59. Co-59 is produced globally, primarily as a byproduct of nickel and copper mining, and used in a variety of industrial applications. The Co-59 used for sterilization accounts for a small portion of overall Co-59 demand. Co-59 is compressed into ‘targets,’ which are pellets and slugs suitable to be activated into Co-60. These targets are then encapsulated and delivered to be installed in nuclear reactors. Depending on the type of reactor and the location of the Co-59 in the reactor, the conversion process can take between 18 months to five years. Once the conversion to Co-60 is complete, the targets are extracted from the nuclear reactor while the reactor is shut down and shipped to Nordion to be processed into Co-60 sources to be sold to customers.
Nordion Products
Co-60 is sold to customers by its level of radioactivity as measured in curies. The company’s customers typically buy low specific activity Co-60 (‘LSA Co-60’) for industrial sterilization use and HSA Co-60 for medical use. At the company’s Ottawa facility, the company receives and processes the targets to form the final Co-60 source product with the desired amount of radioactivity for each customer order. The Co-60 sources undergo stringent and sophisticated quality assurance testing at the company’s facility. The final product is then placed in specialized containers, which Nordion uses to transport Co-60 to the company’s customers.
The company transports the Co-60 sources via proprietary lead and steel containers that are licensed to meet all applicable international shipping requirements. There is a significant regulatory burden in the production, management and transportation of fleets of containers of Co-60 sources. The company’s transportation routes and carriers are highly controlled, and it provides regular and comprehensive training for employees and carriers who are involved in moving the Co-60 globally.
The company also designs, installs and maintains gamma irradiation systems, which include radiation shielding, a series of conveyors and control systems that are designed to expose products to the correct gamma radiation dosage in a safe and efficient manner. A gamma irradiation system is the infrastructure that houses the Co-60 sources and makes up a part of a sterilization and warehousing facility. The company has designed and built over 100 of the estimated 290 large scale irradiation systems active globally. The company’s installation, physics and engineering teams are consisted of highly trained professionals who provide fast and ongoing technical support from source installation to emergency response.
The company also offers its customers a for-fee spent Co-60 source return service for depleted Co-60 sources that have reached the end of their useful life, which is often 20 or more years. The company also has a source recycling program that extends the useful life of individual slugs from the decayed product up to an additional 20 years, pairing them with new slugs to make new Co-60 sources.
Nuclear Reactor Operators
Given the timeline required to produce Co-60, forecasting supply and working closely with nuclear power reactor operators to manage the amount and timing of shipments represents an important business capability of Nordion.
The amount of Co-60 supply is ultimately determined by the number of nuclear reactors that are capable of producing Co-60 at a given point in time. The company’s access to Co-60 tends to vary on a quarterly basis, due primarily to nuclear reactor maintenance schedules, the length of time required to convert Co-59 into Co-60, the limited number of facilities that can generate Co-60 in an economically efficient manner, and the timing of the removal of Co-60 from reactors.
Nordion has access to Co-60 supply at multiple nuclear reactors pursuant to multi-year contracts with three operators that cover 13 reactors at five generating stations, that extend to dates between 2025 and 2064, with the company’s largest supplier under contract until 2064. The substantial majority of the company’s Co-60 material has historically been produced under multi-year contracts with nuclear reactor operators in Canada and Russia. Nordion provides Co-59 targets to its Canadian and Russian reactor suppliers, manufactured to proprietary specifications customized for each supplier. The company also acquires a portion of its Co-60 supply from reactors that produce Co-60 in Argentina, China and India.
In February 2020, the company announced a collaboration with Westinghouse Electric Company to further develop the technology to produce Co-60 in Pressurized Water Reactors. This collaboration could further diversify the company’s supply with the U.S. domestic partners and encourage the implementation of this patented technology at other reactors around the world.
The company continues to evaluate opportunities to increase Co-60 production, including through partnerships with CANDU reactor operators in Canada and Romania that would involve investing in their reactor infrastructure to enable long-term production of Co-60.
Nordion Customers
In 2024, Nordion supplies products and services to approximately 40 customers, including medical device manufacturers and gamma sterilization service providers. Co-60’s consumable nature results in annual natural decay at an approximately 12% annual rate, which creates stable, recurring demand as customers must purchase incremental supply in order to satisfy ongoing needs. The company is integral to its customers’ operations due to highly coordinated and complex installation and service processes that require expertise in handling and shipping radioactive material, as well as the company’s deep knowledge of the relevant regulatory and compliance requirements. Customer relationships are typically governed by multi-year supply agreements.
One of Nordion’s customers is Sterigenics, which competes with several of Nordion’s other gamma sterilization service customers. When the company acquired Nordion in 2014, the company established information barriers between Nordion and Sterigenics with regard to certain customer information, which remain in place, and certain of the company’s agreements with Nordion’s customers require that the company maintains these barriers.
The company supplies HSA Co-60 used in oncology-related stereotactic radiosurgery devices, including the Gamma Knife, which use directed gamma rays for certain oncology applications. The company also supplies other medical equipment manufacturers and sub-contractors in the industry who require the concentrated radiation dose capabilities of HSA Co-60.
Nordion Facilities
Nordion’s operations are supported by a facility in Kanata, Canada dedicated to processing and shipping cobalt, and a European distribution facility in Milton, United Kingdom.
Lab Testing and Advisory Services
Nelson Labs
Lab testing and advisory services are necessary across the medical device and pharmaceutical product lifecycles to evaluate and ensure the safety and effectiveness of healthcare products. The company is a global leader in outsourced microbiological and analytical chemistry testing services for the medical device and pharmaceutical industries. In addition to its testing services, the company’s customers often call upon its experts for technical assistance, regulatory consulting and the company’s advisory services. The company goes to market leveraging its global footprint and an extensive range of services under the company’s Nelson Labs brand.
The company has established itself as a critical partner for its customers through its delivery of high-quality services, quick testing turnaround times, responsiveness, high-touch support and easy accessibility to its science and service teams. The company has an industry-leading brand recognized for the quality and comprehensiveness of its services, both of which can take many years to build. The company’s scale combined with its global network enable it to undertake significant and time-sensitive projects for its customers that might typically require them to interface with multiple labs. This allows the company to simplify complex issues for its customers and streamline communication and execution. Moreover, the integration across the company’s services and facilities enables the company to assist its customers in minimizing their business continuity risk by reducing capacity shortages, turnaround time delays and throughput issues.
The company’s microbiology and analytical chemistry services include over 900 tests. The company also provides for-fee advisory services that position it as thought leaders in the industry and increase the demand for its testing offerings. These can be categorized into three broad categories that address different stages of customers’ product lifecycle:
Product Development and Validation. Prior to a new medical product or alteration to an existing product being submitted for regulatory approval, Nelson Labs provides a variety of tests to customers during the research and development stage. These include tests that assist the client in: product design, material selection, biological safety evaluation, toxicological risk assessment, sterilization modality selection and sterilization validation, cleaning and disinfection validation (for reusable devices), package barrier properties, distribution simulation, and filtration efficiency and physical functionality of PPE (including surgical facemasks, N95 respirators, gowns, drapes and other PPE).
The company provides sterilization modality selection and sterilization validation services for a variety of sterilization modalities, including the three major modalities offered by Sterigenics—gamma irradiation, EO processing and E-beam—allowing the company to serve its customers in multiple areas.
Expert Advisory. Bringing a medical product or drug to market can be a long and complex process, especially in the context of constantly evolving standards in a changing regulatory environment. Nelson Labs provides expert advisory services to aid customers in navigating the appropriate standards and regulatory environments. These services include study design, development and justification of acceptance criteria, onsite facility evaluation and validations, technical troubleshooting and scientific problem solving, and regulatory compliance related services, including supporting clients through the regulatory submission process.
The company’s expert advisory services provide additional value and expertise at any stage of the product development life cycle. Nelson Labs offers these services on a standalone basis or as a combined offering with the company’s lab testing services, which creates opportunities for cross-selling with the company’s existing customers for both services. The company’s expert advisory services are also complemented by the company’s ongoing education offerings conducted through webinars, seminars, tailored onsite education sessions and the company’s website.
Routine Sterility and Quality Control Testing. Once a product has received regulatory approval and is in production, Nelson Labs provides ongoing quality control testing, including production batch verification testing and environmental testing of the client’s production systems and facilities, the requirements for which vary based on applicable standards. Nelson Labs performs bacterial endotoxin testing or quarterly dose audits for devices sterilized using irradiation, and biological indicator testing for devices sterilized with EO. Nelson also provides testing for producers of non-sterile products to ensure they are free of objectionable organisms. Often, Nelson Labs provides this ongoing routine quality control testing (based on production lot sizes) for the products for which it performed initial validation testing. These products are often sterilized by Sterigenics.
The testing process commences when Nelson Labs receives samples and a testing request from the customer. Samples are triaged and assigned to specific lab departments, where laboratory analysts and study directors verify orders and interface with customers directly to clarify, adjust or enhance testing as needed to ensure compliance with regulatory standards. Once the sample has been tested, the order is closed out and results are verified by the study director and a technical reviewer prior to electronic delivery of the final customer report via a secure online customer portal.
The company operates in an industry that requires significant regulatory and specialized scientific expertise. At a minimum, providers must maintain the proper certifications and accreditations from key regulatory and accreditation bodies, as well as obtain qualification by each customer as a ‘qualified supplier,’ which is often required at the corporate level and at each of the customer’s operating sites. The company employs approximately 600 scientists, technicians and service specialists, creating a substantial competitive advantage in terms of expertise. The company’s experts serve in predominant roles on a number of standards writing organizations, including the United States Pharmacopeia, AAMI, American Society of Testing and Materials and ISO. The company has established credibility and trust with regulators and standards writing organizations, which helps the company educate customers about the continually changing testing requirements in a complex and evolving regulatory landscape. The company’s regulatory and scientific expertise in laboratory testing allows the company to serve as a thought leader within the industry and provide high-quality service to the company’s customers. The company focuses on providing highly differentiated services that its customers can rely upon to ensure compliance of and enhance their products. For example, the company has developed a proprietary compound database with over 8,000 known elements, which enable its extractables and leachables testing.
The company provides microbiological and analytical chemistry laboratory tests across the medical device and pharmaceutical industries. Specifically, the company’s medical device lab testing services include microbiology, biocompatibility and toxicology assessments, material characterization, sterilization validation, sterility assurance, packaging validation and distribution simulation, reprocessing validations, facility and process validation and performance validation and verification of PPE barriers and material. The company’s pharmaceutical lab testing services include microbiology, biocompatibility and toxicology assessments, extractables and leachables evaluations of pharmaceutical containers, sterilization validation, sterility assurance, packaging validation and distribution simulation and facility and process validation.
Nelson Labs benefits from many of the same underlying growth drivers as the company’s sterilization business, including the global utilization of medical devices and pharmaceutical products and the importance of compliance with continuously evolving global regulatory requirements. In particular, recent global regulatory changes, such as the enactment of the European Union Medical Device Regulation 2017/745 (MDR) and the FDA’s modernization of the premarket notification process under Section 510(k) of the Federal Food, Drug and Cosmetic Act, have increased the requirements for the testing and sterilization of medical devices. The COVID-19 pandemic also increased testing demand due to new FDA Emergency Use Authorizations (EUAs), which define testing criteria necessary for the direct release of masks and respirators to hospitals and clinics without FDA submission. Because the company provides product development and validation testing services to clients launching new products or altering existing products, this business benefits from the ongoing technological advances and increasing complexity of medical and pharmaceutical products.
Nelson Labs Customers
Nelson Labs serves approximately 3,000 customers, including many leading medical device manufacturers and pharmaceutical companies. The company has recurring and stable customer relationships and benefit from minimal customer concentration. The company’s services are an essential component in the company’s customers’ research and development and ongoing quality control processes but represent a small portion of end-product cost, which allows the company to maintain long-term customer relationships and provide services that are integral to the supply chains of the company’s global customers. The company supports customers through solutions-focused relationship managers, dedicated service centers and a team-wide service ethic. Nelson Labs has developed a proprietary customer portal that provides the company’s customers quick and convenient access to important product information and customer service. The portal allows the company’s customers to see their tests, status of the tests, estimated completion date and final reports and includes a live chat system connected to the company’s customer service team.
Nelson Labs Facilities
The company operates from a five-building campus in Salt Lake City, Utah, with 85 laboratories, including metrology, training, media prep labs, five ISO Class V certified clean rooms and customizable lab spaces. The company also has facilities in Itasca, Illinois; Leuven, Belgium; Pleasant Prairie, Wisconsin; Wiesbaden, Germany, and seven other laboratories embedded in the company’s Sterigenics sterilization facilities in North America, Europe and Asia.
Governmental Regulation and Environmental Matters
The company is subject to environmental, health and safety laws and regulations in the jurisdictions in which it operates, including laws, regulations and permit requirements with respect to its use of Co-60, EO and E-beam. These requirements limit emissions of, and the exposure of workers to, gamma radiation and EO. Nordion’s Kanata facility is licensed as a Class 1B nuclear facility in Canada, regulated by the Canadian Nuclear Safety Commission (‘CNSC’), and is audited across various dimensions of this license on an annual basis. The company’s Nuclear Substance Processing Facility Operating License, CNSC Export license and CNSC Device servicing licenses for its Kanata facility were renewed in October 2015 for a 10-year period and Nordion is engaged in the renewal process for these licenses set to expire in 2025. In addition to the nuclear aspect of its products, many of the products that the company processes are medical devices directed for human use or products used in the manufacture of medical devices that are directed for human use. The company’s facilities hold various International Organization for Standardization’s (‘ISO’) certifications including ISO 9002, 9001, 13485, 14001, 45001 and 17025. The company has device, facility, and specific product registrations with North American (Health Canada and the FDA) and European Drug and Device health regulators. These regulators exert oversight through requirements for a product registration and direct audit of the company’s operations.
Additionally, the company's operations in the United States and the majority of its facilities outside the United States (to the extent it is processing or testing a product that will end up in the U.S. market) are regulated by the FDA. The company is also regulated by other health regulatory authorities in other countries. Specifically, these operations include some of the company's sterilization and product testing activities that may constitute ‘manufacturing’ activities and are subject to FDA requirements. These requirements include site, contract drug manufacturer, and supplier of active pharmaceutical ingredients registration and listing, as well as manufacturing requirements. Regulations issued by the Occupational Safety and Health Administration (OSHA), the U.S. Nuclear Regulatory Commission (NRC), and other agencies also require that equipment used at the company's facilities be designed and operated in a manner that is safe, with proper safety precautions and practices when handling, monitoring, and storing EO and Co-60.
The company is investing in additional controls on EO emissions at its facilities to meet or exceed current and expected future regulatory requirements, and to further reduce facility emissions. In the United States, the company's supplier maintains FIFRA registrations for EO as a medical device sterilant for users of EO across the United States.
In the United States, Sterigenics is subject to NRC and state regulations that govern operations involving radioactive materials at gamma irradiation plants. These NRC and state regulations specify the requirements for, among other things, maximum radiation doses, system designs, safety features, alarms, employee and area monitoring, testing and reporting Each of the company’s U.S. gamma plants has a radioactive materials license from the NRC or the state in which it operates
The company’s Nordion segment operates through its subsidiary Nordion (Canada) Inc. in Canada and REVISS Services in the United Kingdom. Through Nordion, the company is subject to additional Canadian regulations, including Transport Canada regulations for the Transportation of Dangerous Goods, CNSC regulations for the General Nuclear Safety and Controls, Health Canada requirements for drugs and devices and CNSC and Canadian Department of Foreign Affairs and International Trade requirements for import and export.
Outside North America, the European Union and other national authorities have developed regulations pertinent to the operation of gamma irradiators that are similar to those of the NRC. While some specific requirements are different in the various other nations as compared to the United States, the fundamental concepts are consistent among the countries, since all are signatories to the International Atomic Energy Agency (‘IAEA’) conventions and have adopted safety standards from the IAEA and recommendations from the International Commission on Radiological Protection (‘ICRP’).
History
The company was incorporated in 2015. It was formerly known as Sotera Health Topco, Inc. and changed its name to Sotera Health Company in 2020.
