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Biomedical Polymers and Compounds™


Animal Derived Materials in Medical Devices

Posted: January 12, 2018

Definition: Animal Derived Materials (ADMs) include any substance derived from the body of any animal, including fat, flesh, blood, milk and eggs.  ADMs are used in polymers to stabilize formulations, enhance properties and aid in processing.  Recent medical device regulatory trends have increased demand for polymers free of ADMs.

Purpose: Provide an understanding of Animal Derived Materials (ADMs), applications in plastics that are used for the manufacture of medical devices, and current regulatory considerations.

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ProPell™ Low Friction Compounds

Posted: December 14, 2017

Definition: ProPell™ low friction compounds use non-migratory additives to enhance the surface of polymer components and reduce friction.  This technology is particularly beneficial in soft polymers, such as polyurethanes, which are inherently tacky and have high frictional properties.  ProPell™ polymer compounds are USP Class VI compatible and well suited for extrusion and injection molding of medical components.

Purpose: Provide a description of ProPell™ technology and show supporting data.  This data demonstrates efficacy of the technology in soft nylons and polyurethanes, which are commonly used for catheters and other medical components.

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Bioresorbable Polymer Compounds for Implantable Devices

Posted: December 7, 2017

Definition: Bioresorbable polymers are inherently biocompatible, yet hydrolytically unstable.  This allows for applications in temporary implants that are intended to be absorbed and metabolized by the body.  A range of physical and degradation properties allows these polymers to be used for applications that include orthopedic fixation, vascular stents, tissue engineering and controlled drug delivery.  Common bioresorbable polymers include PLA, PGA, PLGA and PCL.

Purpose: Provide an overview of bioresorbable polymers, properties and applications.

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Nano Particle Reinforced Polymer Technology for Medical Devices

Posted: November 30, 2017

Definition: Nano clay particles can be added to medical plastics in low loadings to improve rigidity while preserving elongation and surface finish.  This is advantageous in thin wall applications, such as catheters which require improved rigidity for pushability.  These non-organic, platelet-shaped particles can also improve barrier, thermo-mechanical, flame resistance and processing properties of medical polymers.

Purpose" Provide a basic understanding of nano clay particle additives and demonstrate property enhancements achievable when added to medical polymers at various loadings.

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Radiopaque Compounds for Minimally Invasive Medical Devices

Posted: November 17, 2017

Definition: Polymers are inherently transparent to x-ray.  Minimally invasive medical devices that require intra-operative visibility frequently use radiopaque polymer compounds.  These are blends of polymers and radiopaque additives, such as barium, bismuth and tungsten.  Applications for these blends include cardiovascular catheters, central venous catheters, neurovascular catheters, feeding tubes and more.

Purpose: Provide an understanding of the primary radiopaque fillers used in in medical polymers, including recommended filler loadings for specific polymers.

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Healthcare Associated Infection Prevention

Posted: November 9, 2017

Definition: One in every 25 patients has at least one hospital associated infection.  One in every four of these is related to a medical device, such as indwelling cathters.  Antimicrobial additives, such as ionic silver, can be added to medical plastics to prevent or reduce the infection from these devices.

Purpose: Provide an understanding of the causes of hospital infections and the antimicrobial solutions for reduced incidence rates, with particular focus on additives that can be added to medical plastics.

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Sterilization Technologies for Medical Devices

Posted: November 3, 2017

Definition: The three primary methods for sterilizating medical devices include radiation, ethylene oxide and steam.  Device type, quantity to be sterilized and packaging are a few considerations for selecting the appropriate method.  Polymers used in the device components must also be considered, since some can degrade or diminish in functionality from the sterilization process.

Purpose: Provide an overview of the common sterilization methods used for medical devices and the impact of these methods on medical polymers.

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Overview of Medical Polymers

Posted: October 26, 2017

Definition: Thermoplastics play a critical role in modern medical devices.  Amorphous and crystalline thermoplastics offer distinct performance properties.  Within these categories are a variety of specific polymers suitable for a wide range of device components.

Purpose: An overview of amorphous and crystalline thermoplastics, along with specific examples and attributes for each category.

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Color Additives for Medical Device Plastics

Posted: October 23, 2017

Definition: Pre-color compounds and color concentrates for medical applications are most commonly manufactured using two categories of color additives: FDA Food Contact Pigments, and FDA Medical Device Pigments.  The selection of one pigment classification over the other may affect the FDA approval process for medical devices. 

Purpose: Selection of pigments suitable for medical device plastics

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Polymer Compounding Basics

Posted: October 18, 2017

Definition: Upgrading or adding value of polymers or polymer systems through melt blending & mixing of additives into a polymer matrix or melt mixing two or more polymers together to make an alloy

Purpose: Tailor properties to satisfy a specific applications requirements

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