Biocompatibility and Purity of Medical Device

Medical device manufacturers often use silicone adhesives to bond parts together when assembling products such as catheters, pacemakers, cochlear implants, aesthetic implants, and gastric balloons, due to their biocompatibility and versatility. Selecting the appropriate adhesive can ensure a proper, long-lasting bond, protecting the integrity and performance of the medical device. Manufacturing considerations such as cure rates, adhesive application factors, and surface preparation requirements also affect adhesive selection. By understanding these factors, selecting the optimum silicone adhesive solution can help medical device manufacturers improve their products, increase manufacturing productivity, and gain a competitive edge. Medical-grade silicone adhesive applications are biocompatible and conform with applicable ISO and USP testing protocols. Consequently, silicone adhesives are resistant to chemical attack, oxidation, and shear stresses. They can be readily sterilised by ethylene oxide, dry heat, or other standard techniques without degradation. Device designers should be sure to consider high-purity, medical-grade silicone adhesives with extensive regulatory support and Master Files submitted to the FDA and international authorities. It is also important to select medical-grade silicone adhesives manufactured to strict purity standards with products that use carefully selected raw materials and utilise advanced purification technologies to protect the safety and integrity of the medical devices using those adhesives.