Medical Grade Tubing & Manufacturing: 3 Ways to Reduce Risk

When one of the world’s largest medical device developers presented a scenario in which they faced challenges with their medical grade tubing, Cohesive Components stood out among the crowd of potential sources. Cohesive Components offered cleanly manufactured and processed tubing to eliminate the risk of bioburden on the tubing components.

EXTRUDED MEDICAL GRADE TUBING REQUIREMENTS

The device required several different kinds of tubing, both medical grade plastic and rubber.  The performance of tubing was critical to the function of the class II medical device.

Cohesive Components went beyond the base requirement of simply supplying the tubing. Cohesive Components reduced our customer’s risk in three key ways:

1. Identified better material to eliminate product issue
2. Reduced potential for contamination
3. Improved part traceability and addressed short shelf life

Identified better material to eliminate issue of blooming

During testing, the initial PVC tubing specified had issues with blooming after Ethylene Oxide (EtO) single-use sterilization. Cohesive Components material experts recommended a material for the application that eliminated material blooming and potential contamination.

Reduced potential for contamination

With the elimination of blooming during EtO sterilization, Cohesive Components helped our customer reduce risk of contamination carried within the tubes.

Improved part traceability and addressed short shelf life

Ensuring the extruded tubing is utilized within its recommend shelf life proved a challenge to our client. Cohesive Components ensured the part was extruded, cut, and printed in a clean-room environment with the date of extrusion to address traceability requirements.  Cohesive Components supported our client’s need for small batches to ensure all parts are freshly extruded as to not be used beyond their recommended shelf life.

Additional support for secondary processes

Also, Cohesive Components Application Engineering team fine-tuned the secondary processes, including tipping and assembly of the tubing, to improve the connections between tube and tube fitting by eliminating buckling at the joints.  Thermal forming techniques eliminated flow restrictions and kinking.

Cohesive Components Medical Grade Tubing Services

Cohesive Components offers custom-manufactured medical-grade tubing solutions, providing expertise in material selection, design, and clean room manufacturing in Class 8 facilities to ensure safe and sterile products for medical devices. We offer extruded platinum-cure silicone that is FDA, RoHS, USP Class VI and USP 788 compliant. At Cohesive Components, we specialize in creating reliable and long-lasting tubing that meets specific medical requirements.

Learn more about our custom tubing solutions.