Innovalene® MED 55/65, Innovalloy 8000 and Innovasil® silicone tubing are made of non-DEHP materials, have been formulated specifically to meet the demanding challenges of applications such as dialysis, chemotherapy drug delivery and minimally invasive surgeries. Characteristics from open heart surgery to dialysis, Innovalene® MED 65 tubing has been specially formulated for medical device manufacturers that require a non-DEHP plasticized material. Innovalene® MED 65 sets the new standard for performance and durability in blood contact applications. Based upon a unique chemistry developed by Innovapure, Innovalene® MED 65 Series tubing was formulated to be Registration, Evaluation, Authorization and restriction of CHemical substances (REACH) compliant for DEHP. To ensure compliance, every individual compound lot is tested to ensure DEHP levels are less than 1000 ppm. During the extrusion process, individual product dimensions are maintained and monitored through in-line micrometers and off-line verification with computerized imaging equipment. Consistent with many medical tubing requirements, Innovalene® MED 65 material can be effectively bonded/welded using the following methods: heat, electronic (RF)/ultrasonic, solvent and adhesive. Factors to be considered when selecting the components include: security of the bond required, effect on the integrity of the materials to be joined and presence of residues or extractables that may affect biocompatibility. When bonding procedures are not used, mechanical clamps are recommended to provide secure attachment. Innovalene® MED 65 is made from a biocompatible non-DEHP polymer material developed specifically for blood contact medical device needs. It meets USP Class VI, ISO 10993, European Pharmacopoeia 3.1.1.2 and European REACH requirements. It is also non-hemolytic and non-pyrogenic. It provides ideal alternative solution to replace ND 100-65 in IVD applications.
