Manufacturers and product designers share a desire for continuous improvement. “Good enough” is never good enough. Whether you’re developing an innovative medical device or looking to update an existing product, there are always means for enhancement.
Before going back to the drawing board of your product, consider upgrading the materials of certain components – such as seals and gaskets. Silicone offers several advantages for medical applications compared to other sealing materials, including improved performance, durability, and regulatory compliance.
What are the functions of gaskets and seals for medical devices?
Seals, such as gaskets and O-rings, serve several functions in medical devices. They protect sensitive internal components from contaminants such as dirt, dust, bacteria, fluid, and electromagnetic interference (EMI). Tight seals prevent leaks that could cause the device to malfunction or pose a safety risk to the user/patient. Finally, seals can be designed to maintain the correct pressure and flow of liquids and gases, ensuring that the device works properly.
Benefits of silicone seals and gaskets
The two most common materials for medical-grade seals are rubber and silicone. While natural rubber is the traditional material (and can still be used in many applications), synthetic silicone offers unique advantages for medical devices.
Durability and flexibility – Silicone can maintain a seal after frequent use and bending.
Low compression – Even after prolonged use, silicone gaskets retain their shape and seal.
Thermal stability – Silicone can be exposed to high and low temperatures, which is crucial for medical uses, such as sterilization.
Biocompatibility – Silicone is typically a safe option for devices that involve contact with human skin or tissue due to its non-toxic and non-irritating nature.
Chemical resistance – Silicone can withstand exposure to a wide range of chemicals.
Low outgassing – Silicone releases a low level of chemicals trapped inside the material.
Electrically conductive – Since silicone conducts electricity, the material can be used for EMI shielding applications.
FDA-approved – Silicone gaskets are odorless, tasteless, and fungus resistant.
Manufacturing considerations for silicone seals and gaskets
Before making the switch to silicone, it’s important to evaluate (and potentially test) all materials to ensure they’re suitable for your application. For example, with multi-layer gaskets, material compatibility is a key consideration. Often, differential adhesive is needed to bond a silicone gasket to a dissimilar surface.
Another consideration is the processes required to turn the raw material into the final component. Silicone gasket material comes in sheets or rolls, which need to be converted. This could be as simple as die-cutting for an O-ring or involve several processes for a multi-layered gasket.
At Tapecon, we have extensive experience designing and manufacturing components such as medical-grade silicone seals and gaskets. Our design consultation services include materials expertise to provide feedback or make recommendations based on your design and application requirements. We also have a complete range of converting capabilities at our FDA-registered facility.