The 270-ft² chamber has capacity for two pallets at a time, allowing for batches and products of almost any size, the company said. The equipment is expected to be up and running in early July.
Boulder, Colorado-based Boulder iQ said the new equipment will make Boulder Sterilization the only contract sterilizer offering both CD and ethylene oxide (EtO) sterilization for medical devices and in-vitro diagnostic products.
CD is one potential alternative for EtO sterilization, which is the most commonly used method for medical devices but faces new federal regulations over safety risks to workers and neighboring communities.
Related: FDA reports sterilization challenge progress as EPA takes aim at EtO emissions
“Chlorine dioxide, I believe, is the wave of the future,” Boulder iQ founder, Chair and CEO Jim Kasic said in an interview with Medical Design & Outsourcing. “I decided to get into it and be on the cutting edge, a leader rather than a follower.”
Kasic said Boulder Sterilization can complete validations in as little as four weeks, which can translate to cost savings of 75%.
“By conducting multiple cycles simultaneously, at different set points, we can handle sterilizations more efficiently while mitigating the risk of issues that can occur in the initial cycle,” he said. “It’s one example of the ‘think smart’ approach we use.”
Boulder Sterilization’s 11,000-ft² facility is in Boulder. The building also has a 1,000-ft² Certified ISO Class 7 cleanroom, an inspection and test lab, machine shop, 3D print shop, customizable fume hoods and client-customized wet lab and test set-ups.
Related: How Phiex’s chlorine dioxide method could revolutionize medical device sterilization
This post was originally published on June 5, 2023, and was updated June 6 after an interview with Kasic.