E-Beam Sterilization

APT provides electron beam processing for the purposes of medical device sterilization and medical device modification.

Our Process

Value added services include supply chain logistics using the APT Enterprise Resource Planning (ERP) system and Customer Portal, Just In Time Manufacturing (JITM) Treatment, expedited processing, repacking and re-sorting, and delivering sterile packaging solutions.

Delivery

APT provides environmentally friendly, safe, and pollution-free sterilization services for medical device manufacturers and end users in a direct, rapid, and efficient manner. APT provides superior customer services and seamless integration to qualify and treat customer commodities as if they are our own. We want to make it, Simply Sterile.

Why We Do What We Do

Medical Sterilization in the United States is approaching the cusp of a transformational moment. The market is expected to grow by over 11% per year through 2023 – from $7.9B in 2019 to $11.14B by 2023. Most forecast growth will be in contract sterilization services as manufacturers move away from in-house sterilization.

Global manufacturers currently employ several options for medical device sterilization. These options range from EtO, Electron Beam, X-Ray, and other sterilization methods such as steam. EtO and 60Co control 88% of the medical device sterilization market—EtO commanding 52% and Gamma overseeing a 36% market share. Electron beam sterilization supports 7% overall market share. There is a growing demand and need for sterilization of medical devices and medical equipment.

Although the industry is expecting significant growth, it faces severe challenges to growth. Decreased sterilization availability and capacity are creating a near-national crisis that is requiring an FDA response and intervention. Access, storage, and post-use disposal issues associated with sterilization materials such as Cobalt-60 (60Co) coupled with increased federal, state, and local restrictions tied to Ethylene Oxide (EtO) use are constricting medical device manufacturers and end users’ access to sterile products. The time is right for migration to a cleaner, more efficient, and environmentally friendly medical device sterilization option.

Ethylene oxide (oxirane) molecule. Uses include sterilization of medical devices and as a precursor of polymers. Skeletal formula.

Ethylene Oxide (EtO) has been a workhorse of the sterilization community for over 40 years and provides the baseload of industry needs today. EtO use is increasingly drawing negative attention due to high emissions and rates of cancer in nearby communities. Recent closures of EtO facilities across the nation and the corresponding legal action has led to permanent closure of one of the nation’s largest EtO medical sterilization facilities. Additional lawsuits are threatening closure of several additional EtO companies across the nation. Proposed federal and state legislation prohibiting EtO use compounds the challenges.

In separate studies, EtO emissions were declared carcinogenic by the EPA and the Center for Disease Control (CDC). In addition to known airborne carcinogens, EtO is currently delivered using CFC greenhouse gases (GHG) that will be prohibited by the EPA in 2030. Suitable alternatives to the GHG mixture have not yet proven viable nor effective. A September 2019 Cook County, IL Circuit Court filing described a competitor’s EtO use as, “Just 25 miles southwest of the third largest city in America, the area is a disaster zone. It is America’s Chernobyl.”

The Food and Drug Administration (FDA) will hold an Advisory Committee meeting on November 6-7, 2019, to discuss alternatives to EtO after recent facilities closures in Illinois and Georgia. Additionally, the FDA is currently conducting an “Innovation Challenge 2: Reduce Ethylene Oxide Emissions”. According to the FDA, they are “taking steps to ensure that hospitals, health care providers, and patients have access to medical devices that are safely and effectively sterilized.” The timing is right and the nation needs a suitable alternative to EtO that offers an environmentally friendly and equally effective sterilization mode.

Cobalt-60 provides the second most used sterilization option. 60Co is often referred to as “Gamma Sterilization”, and it provides low temperature and pressure sterilization for numerous medical devices. 60Co is a radioactive material created through nuclear reactor bombardment. The material is highly regulated, difficult to dispose of, and nearly impossible to source due to the current lack of production facilities in North America. Due to national security sensitivities, 60Co requires continuous oversight, security, and facilities outside those normally expected for medical sterilization operations. Disposal requires vendors to file a U.S Government-approved handling, transportation, and permanent disposition plan. In addition to these challenges, access to Cobalt-60 has become increasingly difficult. North America has one vendor capable of providing Cobalt-60, and their supplies have become limited to the point where they can no longer reliably provide raw materials needed to support gamma sterilization, and 60Co half life requires complete resupply after 5 years of use. Gamma sterilization faces survival challenges in the coming years.

Accelerated Particle Technology (APT) offers a capability and the capacity to quickly fill North American medical sterilization needs and shortfalls. APT manufactures, fields, and operates electron beam medical sterilization facilities employing linear particle separators (LINACs) and the most current SCADA and software integration available. APT has capacity to sterilize 60,000 pounds of medical devices per day at the facility. APT sterilization systems precisely monitor, control, and manage every aspect of sterilization operations regardless of the medical device in process. Touchscreen controls and monitors reduce training, sustainment, and maintenance costs and lost sterilization opportunities while enabling throughput rates that exceed those of our competitors.

In addition to technological advances and throughput advantages, APT systems do not involve cancer causing by-products, radioactive materials, or environmentally damaging products like those mentioned with EtO and Gamma. Electron beam sterilization will not create harmful fumes and gasses like EtO, so communities will never fear for their safety, health, or personal security when APT systems operate nearby. During sterilization operations, APT internally shields all operations and processes, so emissions remains within the sterilization target area. Likewise, APT systems only emit energy when in use as opposed to the continuous radiation emissions noted with Gamma. By simply turning off the Master Power Switch, the APT facility is made safe and secure until sterilization operations continue. APT physical security requirements are less than those required for Gamma and EtO, since the systems contain neither carcinogens nor radioactive materials requiring U.S. Government oversight.

APT is dedicated to rapidly fielding near term, regional and international sterilization capability to meet the growing need for medical device sterilization. Current medical sterilization market needs, future growth expectations, and supplier constraints have merged, and APT provides an immediate, impactful, and meaningful solution for filling these needs.

Link to an IIA whitepaper on the subject.

Next Steps…

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