The 125L Ozone Sterilizer is TSO3’s flagship product.

Simon Robitaille first thought of the concept for the 125L Ozone Sterilizer, used to sterilize surgical and diagnostic devices, while he was at an International Ozone Association meeting in 1991. One of the speakers discussed his company’s failed attempt to develop an ozone sterilizer. While listening to the problems the company encountered, Robitaille, who holds degrees in science and environmental engineering and has been involved with ozone and its applications since 1977, realized he knew the solution to their difficulties.

Several years after this meeting, he and his business partner, Jocelyn Vezina, began working on their own ozone sterilizer, using many of the concepts with which Robitaille was familiar.

In 1998, Robitaille and Vezina formed TSO3 Inc. , with a mission to develop and market innovative and comprehensive sterilization technologies. Robitaille serves as COO and R&D director and Vezina is CEO. The 125L Ozone Sterilizer is the company’s flagship product.

Ann Hewitt, vice president of sales and marketing, explains that ozone (O₃), a potent oxidizer, is an unstable gas, which reverts rapidly back to oxygen (O₂). O₃ can only sterilize when it is in a humid environment, and humidity in sterilization is typically created through steam. However, ozone destabilizes very quickly when exposed to heat, which is an inherent property of steam; this tendency had stymied practical applications for an ozone sterilization process. “The other company couldn’t figure out how to humidify the chamber [at a] low temperature,” she explains.

But, instead of humidifying the product’s chamber through steam, Robitaille realized it would be more efficient to boil water in a vacuum and create steam at room temperature. “[The system is] patented like crazy,” she says. The company has strong patent coverage, with six patents either issued or pending, in over 20 countries around the world.

The 125-liter, 4.3-cubic-foot product is intended for hospital applications, due to the size of the chamber. The FDA and Health Canada approved the system in 2003, and TSO3 began selling the product in 2006. So far, the company has sold about 20 units: two-thirds of the sales have been in the United States and one-third in Canada. “Our customers love it,” Hewitt says. “They are very pleased with the machine.”  

She notes that other methods of sterilization use toxic chemicals, which are expensive and dangerous with many opportunities for error by the operator, and safety concerns both for the user and the outside environment. By contrast, the 125L Ozone Sterilizer creates its ozone sterilant from oxygen, electricity and water, so it’s inexpensive to operate and has no toxic byproducts or dangerous emissions. With no sterilant to add to the machine and a single cycle op-tion, there’s essentially no chance the operator can make a mistake, she says.

New Initiatives
TSO3, along with the Health Protection Agency in the UK, is involved in research to demonstrate that the 125L Ozone Sterilizer can inactivate prions, a form of infectious protein that cause diseases called Transmissible Spongiform Encephalo-pathies (TSE’s), such as Mad Cow Disease in cattle and Creutzfeldt-Jacob Disease in humans.

TSE’s are fatal and incurable neurological diseases, and have been shown to be transmitted between patients on contaminated surgical devices. No other form of sterilization can inactivate the protein. “If you were doing surgery on patients that had the human form of Mad Cow Disease, you would have to throw the instruments away in a landfill,” Hewitt explains. “If you didn’t know a patient had this disease, you could infect other patients.

“With surgical instruments that may cost upward of  $25,000 a piece, throwing them away is a financially painful option – but it’s the only way to ensure that you don’t infect another patient by reusing instruments that aren’t safe.”