TSO3’s New Hydrogen Peroxide Sterilizer

TSO3’s new Sterizone® VP4 Sterilizer is a hydrogen peroxide sterilizer that uses ozone to remove residual hydrogen peroxide.

TSO3 is celebrating these days with the recent FDA approval of its Sterizone VP4 sterilizer and commercialization partnership with Getinge, the world’s larges infection control company. It is a major accomplishment for a small company to design and get FDA approval on a new sterilizer, so kudos to TSO3.

TSO3 previously had an ozone sterilizer, the 125L, which it discontinued in 2014 and has since stopped supporting. The new Sterizone VP4 sterilizer is marketed as a combination hydrogen peroxide and ozone sterilizer and required a new classification under the FDA approval since it uses both sterilants.

TSO3 claim that their sterilizer has a short cycle time (46 minutes), which is short but not as short as some of their competitors (Sterrad NX, 28 minutes). However, the much larger (4.4 ft3) capacity will certainly make it attractive to many users.

One interesting point from the 510(k) data is that the VP4 is primarily a hydrogen peroxide sterilizer similar to the Steris V-Pro and ASP’s Sterrad® line of sterilizers, which should simplify material compatibility issues.

At the end of the sterilization cycle the Sterrads use an RF field to create a plasma to lower the hydrogen peroxide concentration; and the VP4 uses ozone similarly. The RF plasma causes the hydrogen peroxide to break down and form hydroxyl and other radicals which would effectively kill any remaining bacteria on the surface of the load. However, at that point in the cycle, the load should already be sterile, so the extra sterilizing effect of the plasma is unlikely to have much effect. Similarly in the VP4 the ozone reacts with hydrogen peroxide to form hydroxyl and other radicals with similar surface sterilizing efficacy. Both the Sterrad and VP4, like the V-Pro exhaust through a catalyst to remove any hydrogen peroxide (and ozone) still remaining.

As has been discussed previously in this blog, while the Sterrad’s plasma may not make a huge difference to sterilization efficiency, it has had a huge impact in the marketing department. We can expect similar benefits for TSO3 from their dual hydrogen peroxide/ozone sterilizer.

While the VP4, like the Sterrads and V-Pro is undoubtedly well designed and will be well made, as with any mechanical system problems can sometimes occur and leaks will be possible. Whether your low temperature sterilizer uses just hydrogen peroxide alone, or a combination of hydrogen peroxide and ozone, ChemDAQ has the gas monitoring system needed to ensure your personnel are kept safe in the event that the unexpected happens.

The Sterizone VP4 offers many other benefits and virtues that TSO3 expound on their website and we give TSO3 our best wishes as they commercialize this new sterilizer.