For many medical devices, electron beam (E-Beam) sterilization is the most cost effective sterilization modality as compared to ethylene oxide (EO), gamma, and X-ray radiation, which together still dominate more than 80% of the single-used device sterilization market.
Though we began with a technology-neutral view, through industry research we rapidly concluded that E-Beam offered the best profile in terms of long-term cost efficiency for most medical devices.
1. Lower Operating Costs
- No Chemical Usage: E-Beam doesn’t rely on consumable chemicals like EO gas. Eliminating gas procurement, handling, and disposal reduces costs. Additionally, E-Beam does not require gas-permeable packaging to function, as does EO.
- Energy Efficiency: E-Beam systems are highly energy-efficient, especially as compared to X-ray systems which consume significantly more power to achieve pallet-level penetration. It’s also important to remember that EO has its own power requirements in terms of maintaining large, heated chambers.
- Rapid Processing: E-Beam sterilization is extremely fast (seconds to minutes per cycle), enabling higher throughput and lowering per-unit costs.
2. No Isotope-Related Costs
- Gamma sterilization depends on cobalt-60, which has high procurement and replenishment costs due to its half-life (5.27 years) and supply chain constraints. A gamma facility will house millions of Curies (MCi) at any given time – all of which is decaying. At the time of this writing a single Curie costs in the single-digit-$ range, which lends an idea of how expensive these radioactive materials can be.
- There are security costs, mainly borne by the US government / National Nuclear Security Agency (NNSA), to secure radioactive sources around the world.
- Since E-Beam uses electricity to generate ionizing radiation, and neither consumes nor produces dangerous radioactive materials, it avoids isotope-related costs altogether.
3. Lower Infrastructure Costs
- Smaller Facility Footprint: E-Beam facilities can often require less physical space as compared to EO and gamma sterilization setups, which reduces real estate and maintenance expenses.
- Simpler Regulatory Compliance: EO sterilization demands strict safety and environmental controls for handling toxic gas. These controls and equipment cost many millions of dollars for implementation and sustainment, adding to both capital expenditure and opex costs that must be priced into EO servicing. E-Beam avoids these extensive requirements.
- No Isotope Regulatory / Security Costs: An E-Beam facility is comparatively simple to permit and register for in contrast to the required, ongoing security measures for securing the highly-radioactive Cobalt-60 “pencils” required for Gamma processing.
4. Accelerated Turnaround Time and Scalability
- No Aeration Phase: EO-sterilized products need aeration to eliminate toxic residues, which can take days. E-Beam products are ready for use immediately, improving inventory management and reducing holding costs for customers.
- Scalability: Many E-Beam systems are built in such a way that they may be modular and scalable, allowing facilities to adjust capacity as needed without significant overhead costs.
5. Macro trends will only increasingly favor E-Beam
- Stable costs: E-Beam’s inputs include grid electricity as well as replacement electrical and conveyor components over time. The outlook for the availability of all of these remains favorable.
- No litigation risk: E-Beam does not rely on highly toxic, carcinogenic gas as an input,a and thus does not have the same environmental / litigation risk profile that we have seen EO present to its operators over the past decade.
- No isotope supply risk: We are not aware of any credible plans to materially increase gamma supply over the coming decade, and expect Co-60 prices to only increase unless they are mitigated by either a) significant alternative (e.g. E-Beam and X-ray) radiation processing supply coming online or b) a significant contraction in demand.
When E-Beam Might Be Less Cost-Effective
- High Initial Investment: Depending on the size of the system and its location, E-Beam facility construction may have higher upfront capital costs for equipment and shielding requirements compared to EO and Gamma systems, although in Gamma’s case, the immediate requirement to provision a new facility with millions of dollars of Co-60 makes the initial investment similar (if not larger.)
- Limited Penetration Depth: E-Beam is less effective for dense or large packages, which may require multiple passes or alternative sterilization methods. The degree to which a product may be processed efficiently in E-Beam is knowable upfront, with higher minimum doses and depths / densities causing pricing to rise as compared to other modalities.
It’s Easy To Know
E-Beam can be more cost-effective in the long term due to lower operating and infrastructure costs, coupled with more rapid faster processing. Further, the outlook for the technology’s continued cost-effectiveness is strong. However, realizing the cost advantages listed here depends on the product type, throughput requirements, and initial setup investment. For customers processing high volumes of products that are E-Beam-efficient, the time, money, and risk profile for E-Beam sterilization is compelling.
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