Boulder iQ introduces contract CD sterilization

Boulder Sterilization, a division of Boulder iQ, will introduce contract chlorine dioxide (CD) sterilization services this summer.

The addition will make Boulder Sterilization the sole contract sterilizer in the world to offer both CD and ethylene oxide (EO) technologies for medical devices and in-vitro diagnostic products.

In offering both services, Boulder Sterilization will be able to meet sterilization needs for almost every type of product, according to Jim Kasic, chairman and founder. “The ability to be flexible and adaptable, handling virtually any sterilization needs for device developers, is crucial today,” he says. “Speeding medical devices to market is both critical and challenging. Boulder Sterilization is helping to meet these demands and get devices into the hands of providers, and patients, as soon as possible.”

The new CD sterilizer, a 270-square-foot chamber (size of two pallets), is the largest contract CD sterilization chamber in the world, says Kasic. It will provide the capability to handle batches and products of almost any size, and allow Boulder Sterilization to meet urgent and immediate-service requests.

Quick-turn, low-cost service

Boulder Sterilization will extend its quick-turn, low-cost sterilization service to CD service. Whereas standard validations in the industry may take 8-10 weeks, Boulder Sterilization has developed a method to complete them in as little as 4 weeks. “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,” explains Kasic. “It’s one example of the ‘think smart’ approach we use.”

• Reduction in validation timeline by 80% – at a 75% cost savings
• Validations: 8-10 weeks
• Single-lot release: 5-7 weeks 
• Engineering R&D sterilization runs: 4 business days
• Production cycles: 4-business day turnaround

Chlorine dioxide sterilization

The CD sterilization method uses the versatile, environmentally friendly chlorine dioxide gas for effective product sterilization. CD works at room temperatures, is low-impact, non-cancerogenic, nonflammable and leaves no post-treatment residuals. It is compatible with nearly all materials, including plastic components and electronics.

As a true gas, chlorine dioxide possesses superb distribution attributes, as it will naturally fill any space evenly and completely. Able to penetrate surfaces and organic matter, the colored gas is accurately measured and monitored. Quick-aeration ability means no condensation on surfaces, and minimal absorption into materials.

“As the market moves increasingly toward safer “green” options of sterilization, we have made the commitment to be there for the industry, leading the way,” explains Kasic. “Our company has always stood at the forefront, meeting the needs of the fast-paced medical device development world. This is one more step along the way.”

Boulder iQ