When producing medical devices and components, manufacturers need resilient materials that perform consistently and reliably, for every patient. The materials used to make products such as tubing and components, catheters, wearable devices, needle-free access valves or single-use applications must meet, or exceed, stringent performance requirements to ensure the utmost level of care for patients receiving treatment. Flexible silicone elastomers are critical to the development of new and innovative medical devices, providing sealing, gasketing, and other properties, that are difficult to attain with many other elastomer materials.
Here are 8 reasons why silicone elastomers are the choice material to consider when specifying materials for device designs.
Silicones provide good thermal stability enabling a device to maintain key performance properties, even after sterilization. Silicones can be sterilized via steam, ethylene oxide (ETO) or gamma radiation.
Silicones are generally inert to bodily fluids and drugs, and have a neutral odor and taste. The chemical structure of silicones allows for USP Class VI and ISO 10993 compliance.
Silicone elastomers are not formulated with additives such as plasticizers or organic material that could negatively impact the performance of drug delivery, and migrate out of the elastomer article.
Silicones offer good resiliency and recovery after puncture for reduced material fatigue. These key features allow silicone elastomers to have a long service life, even at dynamic stress.
Silicones require minimal insertion force allowing for the smooth operation of devices requiring puncture – or for easier assembly when combing other components.
Silicone elastomers can be formulated in a variety of durometers to dictate the hardness or softness of the material, and thus provide the opportunity for improved ergonomics and comfort.
Many silicone elastomer grades are transparent in nature and can be easily pigmented, allowing for ease in colorization.
In addition to durometers and aesthetics, silicones offer a range of options for customization, allowing the material to be considered for a variety of device design applications – from tubing to slit valves to respiratory masks and more. Other customizable options include tensile strength, coefficient of friction, cure and elongation.
Today, there are countless material options for silicone elastomers on the market, such as silicone rubbers for injection molding processes, and high-consistency materials for both injection molding and extrusion processes. Such materials may be simple and straightforward, or highly customized (i.e. UV cure LSRs or self-lubricating rubbers) to meet a particular need.
Finding the right manufacturer is as important as the material performance itself. Strive to find a company that will work with you to help achieve even the most challenging performance requirements--one that focuses on consultation and collaboration over the quest for a transactional sale.