Half of America's medical devices are sterilized with a known carcinogen.
Ethylene oxide. A cancer-causing gas linked to $522M in settlements and counting. The EPA says reduce emissions 90% by 2027. Cobalt-60 gamma can't absorb the demand. There aren't enough machines to replace it. Except now there are.
The sterilization industry is running out of options.
Ethylene oxide (EtO) sterilizes roughly half of all medical devices sold in the U.S. It works. It also causes cancer. Sterigenics and Steris have paid approximately $522M in settlements to date. Thousands more cases are pending. In March 2024, the EPA finalized rules requiring 90% emission reductions at EtO facilities.
Gamma irradiationhandles most of the rest. It uses cobalt-60, a radioactive isotope that decays at 12% per year. Global supply can't grow fast enough to replace EtO capacity.
Sterilization capacity is already stretched thin. Both EtO and gamma face existential pressure. The EPA deadline is 2027. Something has to give.
Seconds, not days. Electrons, not poison.
E-beam sterilization passes products through a beam of high-energy electrons on a conveyor. Treatment happens in seconds per package. No toxic gas. No radioactive source. No aeration period. No quarantine time.
A device sterilized by EtO takes 12 to 72 hours of gas exposure, then days of aeration. Total cycle: up to a week or more before the product can ship.
A device sterilized by Pulse passes through the beam in under a second. Digital dose verification confirms sterility in real time. The product can ship the same day.
This isn't experimental. E-beam sterilization has been used for decades. The FDA classifies it as an Established Category A method. ISO 11137 governs validation. The science is settled.
Why the industry is shifting.
No carcinogens.
Zero chemical emissions. No EtO. No residue on devices. No risk to workers, patients, or surrounding communities.
No radioactive materials.
No cobalt-60. No decay management. No nuclear security requirements. Turn it off, it's off.
Seconds, not hours.
Treatment time measured in seconds per package. Eliminates the multi-day pipeline that ties up working capital.
Real-time verification.
Every device is individually dose-mapped and digitally recorded. No batch sampling. Products can be released immediately.
Broader material compatibility.
Pulse's DUR of 1.1 to 1.3 means almost no over-dosing. Products that can't tolerate gamma's higher dose variability may be treatable by Pulse.
Zero emissions.
No scrubbers. No environmental permits for toxic discharge. Compatible with corporate sustainability goals.
70% of your volume doesn't need X-ray.
The sterilization industry has treated X-ray as the default replacement for gamma. For dense, complex products like orthopedic implants, that tradeoff is worth it. For syringes, tubing, wound care, procedure kits, catheters, and labware, which represent 60-70% of sterilization volume, it's paying a premium for penetration you don't need.
E-beam delivers over 90% energy efficiency. Ten times more efficient than X-ray for the products that fit its penetration envelope.
Pulse designs hybrid facilities. E-beam lines for high-volume products. X-ray lines for dense items. The right modality for each product. One facility. Maximum throughput per dollar.
Bring sterilization in-house. Or let Pulse run it for you.
In-house sterilization transforms a third-party dependency into a manufacturing step you control. Products no longer leave your facility. Cycle time drops from a week to seconds.
A Pulse system fits inside existing facilities. One operator per shift. Implementation in approximately 9 months from contract to operation.
Contract sterilization through Pulse is the alternative. Pulse operates its own treatment facilities and joint ventures. Send your product to us. We sterilize it and send it back. No capital investment required.
The clock is ticking.
March 2024: EPA finalized NESHAP rules requiring 90% EtO emission reductions.
2027:Compliance deadline. Facilities that can't meet the standard face shutdown or civil penalties of up to $124,426 per day per violation.
Today: Incumbent manufacturers have 18 to 24+ month lead times. Equipment orders placed after early 2026 may not be operational by the deadline.
Pulse delivery: Months, not years. From a production line building 100+ accelerators annually.