China-based Ruixiang Silicone has launched a new series of platinum-cured medical-grade silicone tubing designed for manufacturers of cardiac devices, infusion systems and haemodialysis equipment.
Produced at an FDA-registered facility, the product is intended for use as fluid transfer components in extracorporeal cardiac assist systems, micro-infusion systems, and haemodialysis equipment, where tubing comes into direct contact with drug solutions or extracorporeal circulation pathways.
According to Ruixiang Silicone, the launch addresses a longstanding limitation associated with conventional peroxide-cured silicone tubing.
The company noted that peroxide vulcanization can leave behind residual byproducts within the material. If these are not completely removed during post-cure processing, they may gradually migrate into fluids passing through the tubing, creating contamination concerns in drug delivery settings. These residual compounds can also lead to yellowing and surface blooming over time.
Ruixiang said its platinum-catalyzed addition cure process avoids this issue by producing no residual byproducts.
“The reaction proceeds through direct addition chemistry, in which vinyl and hydride siloxane groups combine to form new carbon-silicon bonds without releasing any small-molecule byproducts. Because no residuals are produced in the first place, no high-temperature post-cure cycle is required,” it explained.
The company said this difference can simplify material qualification documentation requirements for medical device manufacturers.
Ruixiang Silicone’s tubing is designed to remain colourless and transparent even after extended storage and repeated autoclave sterilization. Additionally, the optical clarity of the tubing enables visual inspection of fluid lines during operation.
Feng Zhen Huang, CEO of Ruixiang Silicone, said, “Cardiac assist and haemodialysis procurement teams run long qualification cycles. The biocompatibility and extraction data they require takes time to generate regardless of who the supplier is. We completed that process on the platinum-cure line, so customers entering those device categories are working with material that already carries the documentation.”
“At the dimensional tolerances this product operates at, wall distribution inconsistency is not recoverable in post-processing. The vertical extrusion line was built around that constraint from the start,” he added.
Ruixiang Silicone’s new tubing series meets USP Class VI standards and has undergone ISO 10993 biocompatibility evaluation. It is also manufactured under an ISO 13485:2016-certified quality management system.
