Implantable
Biocompatible and highly regulated materials are the primary focus in implantable applications. Specialty polymers designed specifically for implantation are costly and must be processed in cGMP clean room conditions to preserve their cleanliness and biocompatibility. Bioresorbable polymers require special storage conditions to prevent premature decomposition.
Special regulatory procedures and documentation are required for the inclusion of active ingredients due to worker safety issues as well as traceability. Processing equipment must be designed specifically for small batches and high yields due to the high cost of the implantable polymers and active ingredients. Process controls must be extraordinarily precise as excessive residence times or temperature fluctuations can degrade delicate pharmaceutical molecules.
Many implantable polymer formulations are pelletized for injection molding into implantable components. Strand and film extrusion is commonly done directly from the twin screw compounder to allow for precise metered doses to be cut or stamped.
Implantable polymers can also be extruded into tubing components or used to jacket wires and fibers. Precision extrusion processes are required for tight component tolerances as well as minimizing scrap rates of expensive regulated materials. Precision cutting operations carefully meter polymers containing active ingredients and set the stage for final forming and finishing of the implantable component.