Breakable barriers: absorbable polymer films in medical devices

At Poly-Med (PMI), we pride ourselves in being a “one-stop shop”, providing medical grade materials and processing services at our facilities. PMI is a trusted leader in the production of bioresorbable polymers suitable for our client’s needs. We have a variety of polymers that covers a wide range of physical and mechanical properties. Additionally, PMI is an expert on the processing of bioresorbable polymers via extrusion, technical textiles, electrospinning, as well as additive manufacturing processes.  

One of the key components Poly-Med specializes in is film production by either solvent processing or melt-extrusion.  Films have been extensively used as implantable medical devices as barrier applications in general surgery, wound care, and dental products.  Solvent processing of films is used for highly specialized products where heat sensitive materials can also be incorporated.  Solvent processing is able to incorporate multiple materials, layers within the final film construct, and care is often used in the full characterization of solvent processed films to ensure all residuals are removed to an acceptable level.  

Despite the advantages of solvent processing, melt-extrusion is a more industry standard for creation of film substrates.  Melt-extrusion involves the process of melting and metering polymer through a die to achieve the desired thickness and width dimensions upon quenching. Based on the material properties, downstream equipment such as roller systems are put in place to process the film appropriately.  Key components of the film extrusion lines are polymer feeders, extruder with a proper screw design screw, filtration system, die, quenching equipment, roller assembly, winder, and measurement equipment.

Film extrusion field is divided into two (2) categories: 1) cast, or flat film extrusion and 2) blown film. For the flat film extrusion, a die is used to direct the flow of melted polymer into a dimension controlled film. Several aspects need to be considered when setting the die gap distance such as polymer swelling, collector, and desired dimensions. It is critical to ensure constant and uniform flow of the polymer across the area of the die. The downstream equipment such as roller systems are used to ensure that the final product meets the client’s specifications. Typical film specification includes dimensions, texture, uniformity, and material molecular weight among others. Specifications must be clearly defined based on the final product functionality. 

At PMI, our engineers work diligently to identify the balance between process and final product characteristics.  Based on the polymer’s properties and product specifications, process parameters are developed to ensure the constant flow of the polymer and proper quenching of the final product. This ensures that the material is stable to either be used as the final component or be processed based on the client’s needs.

PMI specializes in contract manufacturing of components using medical grade polymers. With PMI’s vertically integrated structure, our diverse team of experts supports our clients from the initial phases of device conception and prototype development to manufacturing by providing in-house device development, project management, quality assurance, and analytical testing. Following process validations and regulatory clearance, PMI provides manufacturing services, inspection plans with validated test methods, packaging, and schedule deliveries to our clients worldwide. Our PMI team is committed to providing high quality products at a reasonable cost through constant process improvement to production lines. Connect with PMI today to hear more about our product offerings and design, development, and analytical capabilities! If you are interested in hearing more about how Poly- Med can help advance your idea and medical product conception, please reach out to us at sales@poly-med.com.

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