Clordisys https://web-clordisys-live-e3evbyfxewdgf3f5.westus2-01.azurewebsites.net/user_area/content_media/processed/logo-white.svg 1-908-236-4100 info@clordisys.com 50 Tannery Rd, Suite #1 Branchburg NJ 08876 USA
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Your Most Complex Devices, Sterilized with Peace of Mind

When your medical devices push the boundaries of what's possible—integrating electronics, featuring intricate geometries, or using sensitive materials—you need sterilization that's as advanced as your innovation. Our contract sterilization facility specializes in the 'impossible' challenges that traditional providers cannot service.

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Our Sterilization Process

Initial Assessment & Consultation

Evaluate product design and sterilization objectives

We evaluate your device's complexity and sterilization challenges, assess material compatibility requirements, and determine optimal processing timelines. Our team develops custom protocols and plans regulatory pathway strategies for approval success.

Confirm product functionality, material compatibility, and microbial lethality

Testing can confirm microbial lethality, product
compatibility, packaging performance, and preliminary
residual acceptance.

Optimize cycle parameters

Sterilization parameters are optimized through exposure studies, environmental conditioning, half-cycle development, and worst-case load evaluations.

Execute validation activities per ISO 14937

Validation studies are executed in accordance with ISO 14937 to demonstrate efficacy, consistency, product compatibility, and process performance.

Support technical documentation and regulatory activities

We provide the technical documentation, validation reports, and risk assessment support needed for regulatory and quality requirements.

Transition to routine sterilization processing

Following validation, the process transitions into routine production with ongoing monitoring, load release support, and commercial-scale processing.

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Get in Touch With One of Our Experts

Our sterilization experts are ready to help solve your complex device challenges and accelerate the path to market.

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Our Facilities & Capabilities

Our state-of-the-art facilities combine cutting-edge research capabilities with world-class sterilization operations. From elemental R&D to full-scale commercial processing, we maintain complete control over every aspect of our chlorine dioxide sterilization process.

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Additional Sterilization Services

EO to CD Conversion Services

Transitioning from ethylene oxide to chlorine dioxide doesn't mean starting from scratch. Our conversion services help you leverage existing infrastructure while upgrading to superior CD technology.

EO to CD Conversion Services
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Medical Devices

Sterilization for surgical instruments, implants, and electronic devices that can't withstand traditional methods.

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Pharmaceuticals

Sterilization for APIs, powders, crystalline, biologics, and lyophilized (freeze-dried) excipient materials.

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Combination Devices

Processing for drug delivery systems that may be temperature sensitive and require minimal residual concerns

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