2014: When the FDA Approved REVOX Sterilization Solutions' New Peracetic Acid Method
As 2015 brings with it new clients and new opportunities for REVOX® Sterilization Solutions to enable and advance innovative products and processes, we also look back at how far we’ve come.
Several years after having conceived of the concept of Peracetic acid-driven vapor sterilization, 2014 was the year when the proverbial rubber met the road. Last year, our team collaborated with a range of experts, from engineers to surgeons, researchers to CEOs, to learn the limits of existing sterilization technologies and to explore the potential for the REVOX sterilization technology. We also succeeded in having our room-temperature sterilization process approved for clinical trial products in two European countries. But the culmination of 2014 was when REVOX was accepted as the sterilization method for a new FDA 510(k) application of OsteoSymbionics’ CLEAR SHIELD® cranial implant. This is no small achievement in an industry where the last new technology introduction occurred more than two decades ago.
All these innovations REVOX sterilization is enabling have meaningful, real-world implications, whether it’s sparing a child multiple operations, reducing surgical complications, or enabling elderly patients with chronic conditions a better quality of life. Here at REVOX Sterilization, we share our clients’ passions for bringing these new efficiencies and products to market. And we treat every client, their product, and their product’s potential as the next milestone.
While our clients primarily come from the medical and pharmaceutical industry, each one comes with a different problem to solve and a different challenge to overcome. Geographically, our clients span the globe from New Jersey to New Zealand. Their sterilization experience ranges from none to “let me teach you a thing or two.” Their level of urgencies range from yesterday to someday. And the volume of product output they need ranges from a couple dozen per year to a couple dozen trailer-loads before noon.
As we here at REVOX Sterilization Solutions look ahead to 2015, I’m confident the number of REVOX partners will grow, just as the REVOX™ machine will. This year, we plan on introducing a 3000-liter chamber version (up from the current 417-liter chamber) to accommodate customers with even higher volume, in-line needs. It’s all part of our desire to provide best-in-class, just-in-time℠ sterilization for our client. So, we’d like to thank our clients of 2014, as well as the many others we’ve worked with in the past year, for entrusting the REVOX team with the chance to help you “make it possible.™”