Does Your Product Need a More-Flexible Sterilization Cycle?

A process control system for EtO sterilization chambers could give medical device companies "precise" control.

Customers access securely their own chamber simulator via the Internet. The hosted simulator system resides on Konnexis servers behind Advanced CISCO firewall. Each customer has a dedicated database.

Drug-coated products and other novel materials are presenting some unique challenges for EtO sterilization. “These products need more flexibility than a traditional cycle can provide,” Peter Veselovsky, president of Konnexis, told MD+DI. Sterilization of these newer products often requires “precisely controlled low-temperature, low-humidity environments.”

Different techniques can be used to extract EtO, Veselovsky explains, but because there are different acceptable residual levels, “flexible sterilization cycle designs are needed to meet stringent requirements,” he explained. “And innovative cycles are needed to deliver EtO in faster ways.”

Veselovsky has been helping medical device manufacturers develop and control such flexible EtO cycles through Konnexis’s AccuSolo sterilization process control system. Launched in 2014, the software can be used to control any EtO chamber produced by any manufacturer using one validated version of software. “We can control even the most complex chambers,” he said.

Using Konnexis’s system, “medical device manufacturers can develop and validate an EtO process on their in-house chamber and then export the recipe to any contract sterilizer (that uses AccuSOLO),” he added. “Many top-ten medical device companies also do this to back up their own internal processes in case they run out of capacity.”

Companies can run their cycles on all chambers across all global locations, and new versions of the upgradable and scalable software can be applied to a site when requested. “If any issue is discovered anywhere from any user, we can make sure it is corrected and enhancements are distributed. And as new features are added, they become available to the installed base,” he said.

In the event of a catastrophic PLC CPU failure, Konnexis’s system allows restoration to the point of failure without a redundant PLC system, the company reported.

Such capabilities are “not easy for a custom SCADA solution, and changing all chambers to operate in the same way is not economical,” he said.

Konnexis currently serves about 60 installed EtO chambers globally, “all running close to the same version,” he said.

In 2015, the company began offering a hosted service simulator that allows customers to design cycles and run them on a virtual chamber. “The solution allows users to test these cycles in the cloud,” Veselovsky said. “Operators can be trained using the simulator instead on an actual chamber.”

To help manufacturers develop the cycles needed for novel materials, AccuSolo has been “augmented with a peristaltic pump to deliver precise humidity levels in a unique way other than pressure,” he explained.

Recipes can also be built around “families of products,” he said. “This can help save time, instead of running everything at worst case.” Because AccuSolo can interface with corporate ERP systems, bar code scanners can be used to identify recipes for product families to ensure the right cycles are chosen.

And to help prevent accidents, Konnexis has also built in a flammability analysis tool, which provide predictive analysis of the gas composition. “Mixtures will show up graphically on charts,” he explains. “If there is too much EtO in the chamber, air valves won’t be able to open. Safety interlocks are designed to prevent accidents. We’ve eliminated what caused accidents—phase advance. Instead, the cycle aborts safely using an automatically determined sequence.” The system can also warn users about too much humidity at certain temperatures.

Veselovsky said configuring AccuSolo takes just a few hours, compared with a month or more required to develop software customized to a particular chamber.

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For the latest insights on medical product development, R&D, user-centered design, and more, attend the conference at MD&M Minneapolis November 8-9, 2017.

 

 

Daphne Allen

Daphne Allen is a contributor to MD+DI and currently serves as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered pharmaceutical and medical device packaging, labeling, manufacturing, and regulatory issues for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

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