Silicone tubing used in medical devices and pharmaceutical applications has particular requirements. Among them are the ability to withstand sterilization processes and the requirements of various associations such as FDA. The industries have tubing needs involving flexibility, performance, the absence of animal-derived ingredients and cost that are common to many applications.
The following questions address two critical requirements involving silicone tubing for medical device applications.
Q: The device I’m working on needs to be sterilized before use, but I’m not sure which sterilization methods might be used at this point in my design stage. How do I know which type of silicone tubing to spec in?
A: Silicone, often selected because of its flexibility and its capacity to withstand both high and low temperatures, can handle more than one sterilization process. Autoclaving, gamma irradiation, and EtO (ethylene oxide) are common forms of sterilization for medical devices, and depending on the particular formulation of silicone tubing, more than one sterilization method can be accommodated. Ask your supplier(s) which types of sterilization their silicone tubing can handle. Learn more
Q: How do I know if the tubing meets the regulatory documentation needed?
A: In the U.S., the Food and Drug Administration determines whether medical devices are safe to use and do what their manufacturers’ say they will. Devices can include silicone or plastic tubing for fluid or gas transfer or for use as a protective covering. When it comes to that tubing, the FDA’s oversight involves everything from the individual ingredients that make up a plastic or rubber compound, to manufacturing processes, to the tubing’s reaction with substances and materials with which it comes into contact. Learn more