CONTRACT MANUFACTURING SERVICES

Poly-Med offers the deepest experience and widest range of customizable products to support the development of solutions based on unique bioresorbable polymeric materials, as well as comprehensive support for regulatory approval enabling the quickest and most cost effective path to market.

Polymerization

Standard and customized medical grade resins are produced on site to meet unique and exacting customer requirements. Virgin resins and compounded forms (dyes, inorganic filler, blending, etc.) are produced for additional processing via extrusion, injection molding, or solvent processing.

Extrusion

Monofilament

Melt extruded filaments in a variety of diameters, typically from about 0.10mm up to 2mm. Monofilaments can be further oriented to increase tensile strength and modulus, or to enhance flexibility.

Multifilament

Melt extruded multifilaments from 2 to 88 ends and between 1.5 and 30 denier per filament. Multifilament fibers are oriented in-line and supplied on spools or cones for downstream processing.

Microfilament

Melt extruded single filament fibers with small diameters, typically between 30 and 150 µm. Microfilaments can be further oriented to increase tensile strength and modulus and are supplied on a variety of spools or cones for further processing.

Film

Melt extruded films range in width and thickness for a variety of applications. Typical thickness is between 0.05 and 0.5 mm and can be supplied on a roll with or without a backing material.

Tubing

Melt extruded profiles and round tubing are prepared in a variety of sizes and shapes for additional processing. Parts can be annealed to increase crystallinity and part stiffness.

Compounding

Filament materials can be compounded to incorporate inorganic content, such as barium sulfate or tantalum for radiopacity, or to include other bioactive materials.

Fiber Processing

After extrusion, extruded parts can be processed by orientation to enhance crystallinity and strength. Annealing/heat treatment cycles are also used to stabilize the construct and relieve internal stresses that may damage shelf life and degradation performance.

Electrostatic Processing

Production scale electrospinning for processing of various materials into nonwoven, nano and microfibrous structures. The fabric can be supplied in sheets of various size and thickness, or directly applied to components as a covering.

Textiles

Warp Knitting

Raschel warp knitting is available to co-knit up to 4 different materials in a wide variety of patterns. Both monofilament and multifilament yarns can be used to create customized mesh fabrics.

Weft Knitting

Circular knit constructs in a wide variety of densities with diameters from 0.25 to 6 inches.

Braiding

12- and 16-carrier braiders produce a variety of customized braids. Axial and core insertions are also available.

Surface Treatment

Coating

Continuous coating of suture and fiber materials and batch coating of textile constructs to modulate lubricity or enhance other performance characteristics.

Chemical Modification

Side chain modification of polymer surfaces to add specific chemistries, like succinate or amine groups. This process is performed in a batch operation.

Packaging

Ultra-low moisture content drying and packaging is employed to assure the longest product shelf stability. High barrier foil laminates and hermetically sealed pouches provide low moisture and oxygen permeability, and clamshell packaging is often used to provide further protection.

Labeling

Poly-Med materials and components are fully traceable from raw material to finished good. Our labeling provides critical lot information and product attributes that is easily readable and printed on thermally printed label stock.

Sterilization

We utilize industry-leading partners for Ethylene Oxide (including low temperature cycles), Gamma and E-beam sterilization, and can coordinate and maintain product-specific validations for a variety of products.

Storage

Absorbable materials are sensitive to degradation from atmospheric moisture. Throughout Poly-Med’s facility, in-process and final product storage has been implemented to dry product without damage and maintain consistent part quality.