For over 25 years Foster Corporation has been serving medical device manufacturers with technology and service in custom biomedical polymer compounding. Within two ISO 13485:2003 and ISO 9001:2008 certified facilities, Foster offers expert formulation development and production of polymer enhancements including radiopaque fillers, custom colors and other specialty additives.
Featured technology: ProPell Compounds, PureEase, Medibatch Color Concentrates
- ProPell Compounds: ProPell thermoplastic polyurethane (TPU) and polyether block amide (PEBA) are compounds for the improved manufacturing and handling of medical catheters. These new compounds reduce tackiness and friction in soft, flexible polymers while maintaining other physical properties of the unmodified polymers. ProPell low friction compounds use a proprietary, non-migratory additive that enhances the surface of parts without substantially altering the physical properties of the polymer. Tests show that parts produced from ProPell TPU have a dry coefficient of friction of 0.05, representing a 66% reduction compared to the unmodified TPU polymer with a hardness of 80 Shore A.
- PureEase: PureEase technology is used for improved extrusion processing control. This additive system was developed to help maintain consistent processing parameters of validated TPU based polymers and compounds. Consistent processing parameters can mean tighter ID/OD tubing tolerances especially in small tubes. PureEase technology is available in custom TPU based compound formulations used in radiopaque filled tubing applications commonly used in central venous catheter (CVC) tubing. It can also be useful in unfilled TPU polymers as well, in applications where tight tolerances are necessary such as wound care films.
- Medibatch Color Concentrates: Foster’s MediBatch color concentrates use FDA 21CFR 73 subpart D pigments for medical device applications and in support of medical customers in early stages of product development, they are available in quantities as low as a single pound. Medical devices often use custom colored components for branding, aesthetics, or functional purposes. Color concentrates, blended with unpigmented polymers are widely used as an economical alternative to pre-colored formulations for injection molded or extruded plastic components. Use of pigments that have been previously evaluated for use in medical devices may reduce the FDA review time for a new device and expedite the approval process.
Visit Foster’s booth at DeviceTalks Boston.