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Sterilization Management for Finished Medical Devices and Sub-Assemblies

Medical device companies trust Cirtec’s Sterilization Management program to care for their terminal sterilization requirements.

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Released By Cirtec Medical

Sterilization is a critical process for many finished medical devices and sub-assemblies. From components to long term implantables, medical device companies trust Cirtec’s Sterilization Management program to care for their terminal sterilization requirements. Managed from our Enfield, Connecticut and Brooklyn Park Minnesota locations, Cirtec offers our partners full sterilization management services.

Cirtec’s in-house EO sterilization services are ideal for sterilizing smaller lots for research, clinical trials and functionality/compatibility testing. Whether utilizing our in-house EO sterilization capabilities, or a Cirtec managed third party for Gamma, E-beam, and other terminal sterilization methods, we take on every aspect of the process – from sterile pack design, process validations, to final sterile release. In addition, our team handles bioburden and endotoxin testing, sterile pack integrity, complete sterilization cycle documentation, and overall logistics.

Save time, manage costs, and mitigate risk in product development and production by leveraging Cirtec’s complete Sterilization Management. Cirtec Medical is a vertically integrated, full-service outsource partner providing end-to-end product design, development, and manufacturing of Class II and III medical devices and components. We have the expertise and capabilities to bring devices from idea and design to prototype and manufacture, and finally to market. We specialize in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems.

Cirtec has more than three decades of experience as an industry leader in the medical device industry. Our international teams operate throughout the United States, Costa Rica and Germany, with additional support from our subsidiaries, NovelCath, Inc. and Vascotube GmbH. Our facilities include over 400,000 square feet, multiple clean rooms, 3D printing, manufacturing, prototyping, circuit design, and more.

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