Boulder iQ is now offering outsourced process equivalency service for ethylene oxide sterilization.
Critical for medical device product developers and manufacturers, process equivalence demonstrates that two or more pieces or sets of equipment deliver the same validated sterilization process. The equipment does not need to be physically identical, but needs to be capable of running the processes within defined, validated process limits.
Boulder iQ’s new service includes rigorous internal procedures to conduct process equivalence from equipment in other facilities. This allows companies to easily transition to a new piece of equipment, switch sterilization vendors or have more than one sterilization vendor. Boulder iQ follows Association for the Advancement of Medical Instrumentation (AAMI) TIR 28:2016 product adoption and process equivalence for ethylene oxide sterilization guidelines.
“The process equivalence service addresses a critical market demand right now, brought about by a change in servicing of sterilizers/aerators,” says Jim Kasic, chairman and founder of Boulder iQ and its Boulder Sterilization Services division. With 3M no longer servicing its Steri-Vac Sterilizer/Aerator XL Series, many device developers are moving to the company’s GS series, he explains. “While the two sterilizers are similar in many ways, device developers will need to conduct process equivalence testing to switch their products to the new equipment – and do it quickly.”
Boulder iQ will set up a process equivalence program for each client, and can conduct all testing at the client site. The company’s sterilization specialists will establish the process equivalence through the following steps.
- Determine amount of testing required through an initial review of equipment and validation
- Analyze the process data to demonstrate that the equipment’s performance is acceptable, and that the process consistently operates within the defined tolerances of the validated parameters
- Conduct a microbiological evaluation to demonstrate the required sterility assurance level
- Prepare a summary report
“Boulder iQ has the proven experience and expertise in process equivalency, in ethylene sterilization, and with the Steri-Vac equipment,” says Kasic. “Completing process equivalency efficiently can make a real difference in the ability of developers and manufacturers to avoid any interruption in the flow of their products to the market.”
Boulder iQ (http://www.boulderiq.com)
Boulder iQ is an expert contract firm that provides life sciences companies all the services they need to bring products to market. With specialties in regulatory affairs, quality assurance, design, engineering and manufacturing, the company’s single-source program speeds product development. The Boulder Sterilization Services division, providing quick-turn ethylene oxide sterilization, final assembly and packaging services, is the recent recipient of a $250,000 grant from the Colorado Office of Economic Development and International Trade’s Advanced Industries Accelerator Grant Program.
Based in Boulder, Colorado, Boulder iQ is ISO 13485:2016 certified through Boulder BioMed. The company’s Boulder Medical Device Accelerator provides equity investment in start-up companies seeking product development services, expert mentoring and infrastructure support.
