Drug-coated products along with other novel materials are presenting some unique challenges for EtO sterilization. “These products require more versatility than the usual traditional cycle can offer,Inches Peter Veselovsky, president of Konnexis, told MD+DI. Sterilization of those newer products frequently requires “precisely controlled low-temperature, low-humidity environments.”
Different techniques may be used to extract EtO, Veselovsky explains, but since there are different acceptable residual levels, “flexible sterilization cycle designs are necessary to meet stringent needs,” he described. “And innovative cycles are necessary to deliver EtO in faster ways.”
Veselovsky continues to be helping medical device manufacturers develop and control such flexible EtO cycles through Konnexis’s AccuSolo sterilization process control system. Launched in 2014, the program may be used to control any EtO chamber created by manufacturer one validated form of software. “We can control the most complex chambers,” he stated.
Using Konnexis’s system, “medical device manufacturers can be cultivated and validate an EtO process on their own in-house chamber after which export the recipe to the contract sterilizer (that utilizes AccuSOLO),” he added. “Many top-ten medical device companies also do that to assist their very own internal processes in situation they exhaust capacity.”
Companies can run their cycles on all chambers across all global locations, and new versions from the upgradable and scalable software does apply to some site when requested. “If any risk was discovered between any user, we are able to make certain it’s remedied and enhancements are distributed. So that as additional features are added, they become open to the installed base,” he stated.
In case of a catastrophic PLC CPU failure, Konnexis’s system enables restoration to begin failure with no redundant PLC system, the organization reported.
Such abilities are “not simple for a custom SCADA solution, and altering all chambers to function in the same manner isn’t economical,” he stated.
Konnexis presently serves about 60 installed EtO chambers globally, “all running near to the same version,” he stated.
In 2015, the organization started supplying a located service simulator that enables people to design cycles and run them on the virtual chamber. “The solution enables users to check these cycles within the cloud,” Veselovsky stated. “Operators could be trained while using simulator rather with an actual chamber.”
To assist manufacturers get the cycles required for novel materials, AccuSolo continues to be “augmented having a peristaltic pump to provide precise humidity levels inside a unique way apart from pressure,” he described.
Recipes may also be built around “families of merchandise,Inches he stated. “This might help save your time, rather of running everything at worst situation.” Because AccuSolo can interface with corporate ERP systems, barcode scanners may be used to identify recipes for product families to guarantee the right cycles are selected.
And also to assist in preventing accidents, Konnexis has additionally built-in a flammability analysis tool, which offer predictive research into the gas composition. “Mixtures can have up graphically on charts,” he explains. “If there’s an excessive amount of EtO within the chamber, air valves won’t have the ability to open. Safety interlocks are made to prevent accidents. We’ve eliminated what caused accidents—phase advance. Rather, the cycle aborts securely utilizing an instantly determined sequence.” The machine may also warn users about an excessive amount of humidity at certain temperatures.
Veselovsky stated configuring AccuSolo takes only a couple of hrs, in contrast to per month or even more needed to build up software customized to particular chamber.
For that latest insights on medical product, R&D, user-centered design, and much more, attend the conference at MD&M Minneapolis November 8-9, 2017.