Ask the Expert

Ask the Expert

Silicone Tubing for Medical Devices – Determining Which Type to Use

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 the 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.


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Question 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?
Answer 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.

Sterilization costs vary greatly, so choosing tubing that can be sterilized by the least costly method may help minimize the overall cost of your medical device. If sterilization for reuse is involved, consider whether the labor and equipment involved with cleaning is worth the expense. In some cases it may be more economical — and safer for the patient — to simply replace the tubing. Will your design make tubing replacement an easy task?

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Question How do I know if the tubing meets the regulatory documentation needed?

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Answer In the U.S. the Food and Drug Administration (FDA) 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.

Of critical interest are the materials that make up the tubing. Ideally all ingredients should be lot traceable. They may also need to meet regulations involving United States Pharmacopoeia (USP) Class VI, Underwriters Laboratories (U.L.), the National Sanitation Foundation (NSF) or other organizations. Documentation such as Material Safety Data Sheets and records regarding the origins of the tubing's ingredients may need to be kept on file. For silicone tubing, the curing process (peroxide or platinum) can also be an important part of the tubing selection process. Different cure methods result in different degrees of extractables and leachables.

Your tubing supplier should be able to tell you what documentation they can provide with their product, but do not assume they will have all the documentation you need for regulatory concerns and records. In some cases it may be necessary to have your own testing performed by an independent laboratory.

 


 

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