The SPE Library contains thousands of papers, presentations, journal briefs and recorded webinars from the best minds in the Plastics Industry. Spanning almost two decades, this collection of published research and development work in polymer science and plastics technology is a wealth of knowledge and information for anyone involved in plastics.
The chemical and physical effects of ionizing radiation on polymeric materials is reviewed with a primary focus on radiation sterilization of disposable medical device materials.
In the present paper, we have studied thermal properties and thermo-chemical stability of a medical-grade adhesive comprised of a cationic, cycloaliphatic epoxy resin system by using differential scanning calorimetry (DSC) and thermo-gravimetric analysis (TGA) techniques. Then, we have explored UV curability of the adhesive by performing a series of the UV-cure experiments using special photo- DSC (or p-DSC) technique and investigated relevant relationship of resultant thermal properties and thermochemical stability of such UV-cured adhesive materials with the underlying UV irradiances during UV curing. Thereafter, we have further examined thermal curability for various post-UV cured adhesive materials by conducting a series of the thermal-cure experiments and measured the ultimate glass transition temperatures of resultant adhesive materials at various “fully-cured” states with using a conventional DSC technique. According to these thermal analysis tests, p-DSC UV-cure experiments, and DSC thermal-cure experiments, we are able to thoroughly understand effects of UV irradiances applied during UV curing on dual UV-thermal curability and resultant thermal properties of various resultant adhesive materials at the “fully-cured” solid states to provide pertinent scientific insights on relevant adhesive handling and processing operations in making medical devices.
In an attempt to attest and justify that a polymeric medical device as possibly affected by some polymer process change(s) of device manufacturing would be substantially equivalent to relevant legally-marketed counterpart in view of its biological safety and functional effectiveness, a practical approach for statistically evaluating inherent thermo-chemical stability of polymer, namely activation energy of thermal degradation that is closely dependent of the underlying thermal history of device manufacturing, is proposed in compliance to relevant regulations and industrial guidelines. Accordingly, a series of thermogravimetric analysis (TGA) experiments can be comparatively conducted per ASTM E1641 standard practice and then kinetically studied to determine the measured activation-energy means for some “test” polymer samples taken from affected device, compared to some “control” polymer samples taken from relevant legallymarketed device, using the so-called Ozawa-Flynn-Wall analytical method. The statistical equivalence or superiority of affected device, compared to legally-marketed device, can be then technically assessed by performing the pertinent two-sample (Welch) t-test on any statistical differences in the so-measured activation-energy means between the affected and “control” polymer samples.
Multi-component injection molding of liquid silicone rubber (LSR) with thermoplastics, such as PBT or polyamide, is used in the manufacturing process for many components in the automotive industry and in the field of sanitary technology. Due to its hypoallergenic properties, biocompatibility, and resistance to the majority of liquid medications, liquid silicone rubbers are a promising alternative material for use in medical applications. They can be used over a wide temperature range and they are physiologically well tolerated and can be sterilized in various ways. Standard thermoplastics, such as acrylonitrile butadiene styrene (ABS), cannot be overmolded with silicone rubbers in injection molding because of their low heat deflection temperature. With the right production method that combines the processing of silicone rubber and thermoplastics, it would be possible to replace the formerly expensive production and assembly of individual components. Such an integrated production technology makes it possible to realize high-performance new products economically and at the same time, to improve product safety for the patient through simplified, more highly automated and higher-quality production. In this investigation, we applied ABS grades, approved for medical applications, to show how ABS-LSR test specimens regarding the VDI guideline 2019 could be produced using variothermal mold heating and special surface treatment of ABS. Here we will show the development and challenges of a new 2C-molding technology for LSR – thermoplastic parts. For the quality of the later product, the adhesion between thermoplastic and LSR is the decisive feature and depends not only on the injection molding process, but also on the material pairing and the treatment process. Here, we succeeded to manufacture multifunctional products for medical devices through various partial pretratment methods of the thermoplastic surface. In addition, the effect of sterilization (gamma and eto) and artificial aging (humidity and temperature) and of such components on the adhesive bond is indicated.
In addition to polymers based on non-fossil feedstocks that help reduce carbon footprint or blends that incorporate recycled content to reduce waste, there additional strategies a manufacturer can pursue to further lower energy consumption and material usage. In this presentation, we delve into polycarbonate materials chemistry and property profile to point out cases where the material and process innovations come together to maximize productivity and lower energy consumption or even lower material consumption to reduce waste. How these fit together in a greater context of plastics manufacturers looking to be part of an emerging circular economy will also be discussed.
We report using the coordinated silver (I) complex based on SIL in a toughened epoxy resin composite to enable electrical and thermomechanical properties. The toughened epoxy resin was aligned at the molecular level utilizing an electric field, demonstrating a relatively high electric conductivity, energy storage, and rapid curing behaviour that can save energy, reduce unnecessary heat, and optimize capital and operating costs. Applying Small Angle Neutron Scattering (SANS), our work thoroughly studied the effect of alignment changes on the silver (I) complex and AgNPs under an applied electrical field and assessed the stability of the alignment after the electric field was constantly removed. Furthermore, the in-situ SANS investigation of the kinetic effects under external impulse influence helped identify the clusters of silver under an external electric field in various composite matrices. This technology can be used for accurate noninvasive blood circulation; increasing material electrical conductivity by applying induced electric field molecular alignment can tremendously increase sensor sensitivity. This approach opens the door to the next generation of thermoset polymers with multifunctional properties.
A recent design of a new screw referred to as the No Solid Bed (NSB) screw was introduced and the initial operation was presented . This new screw has channels in the transition section that do not allow a compacted solid bed to form. The data presented here compliments the data that was previously published.
ASTM F1980 provides a methodology for accelerated aging of sterile barrier systems for medical devices, and is also widely used as the definitive guide for accelerated aging of medical devices and pharmaceutical packaging. ASTM F1980-16, as well as previous versions going back to 2007, emphasize that when increasing temperature to accelerate aging, it is preferable to decrease relative humidity so as to maintain an approximately constant moisture content. However, there is a revision under consideration by the ASTM F02.50 committee that would dramatically change this guidance to indicate a preference (although allowing for other options) to keep relative humidity approximately constant. This change is based on somewhat limited test data and literature review published recently by Thor et al. In this paper, we perform a study looking at eight resins (PP, COC, ABS, PC/PET, Copolyester, PBT, PA66gf, PUR) that have been aged at 60C and three different RH levels to evaluate the impact on aging. Our findings to date indicate that: (i) yes, it is likely that RH should be held constant when increasing temperature in order to keep moisture constant in the resins at a similar level; and (ii) for the medical-grade resins evaluated here, RH level does not significantly impact the physical aging mechanism. We also recommend that further accelerated aging studies are performed to more thoroughly evaluate the impact of moisture content on Q10 factors, corrosion rates, and other endpoints before this dramatic change is made to the ASTM F1980 standard.
CFD-Simulations are a common tool to design and optimize mixing elements. The manual evaluation and experience-based derivation of an optimized geometry is still an iterative process which is time consuming. In this paper an automated algorithm is developed and tested for a mainly distributive Block-Head-Mixer. To automatically evaluate the flow field of each geometry variant, quality criteria are introduced which enable the assessment of the mixing capability. The investigation showed that the quality criteria are suitable to evaluate the flow field and an optimized candidate compared to a starting geometry could be found automatically.
In polymer extrusion, the die temperature is normally set to the recommended temperature in order to reach a homogeneous melt. Nevertheless, the measurement of the melt and surface temperature of the product leaving the die is not state of the art due to the difficulty of an inline - measurement. As a consequence, the product temperature leaving the die is assumed as the set die temperature. Therefore, this article aims to engineer an inline-measurement system of the surface temperature of square hollow profiles immediately after leaving the die. First, two objective quality criteria to define the thermal melt homogeneity, named weighted melt temperature and radial temperature, are introduced. After that, experimental investigations are carried out for two different types of polyolefin polymers with the variation of several process parameters such as the screw speed and the die temperature. In order not to distort the product, the developed construction is based on a contactless measurement system using infrared pyrometers to measure the average surface temperature on each side of the profile. After all, rules of behavior are derived from the process and correlations between the investigated process parameters and the melt quality as well as the surface temperature are identified.
Pipes for heat exchanger systems are usually made of metals to achieve a high level of energy transfer. Polymers, in comparison, save weight and costs and are suitable for use in corrosive and chemically aggressive environments. However, for many applications the comparatively low thermal conductivity of polymers is a disadvantage. To overcome this, polymers are usually mixed with high amounts of fillers, which transport the heat through the pipe wall. But the use of high filler ratios influences the mechanical properties of the pipe significantly. The aim of this paper is to develop a concept for a pipe extrusion die which aligns the filler particles in radial direction, so that the anisotropic material properties of the compound can be utilized and thus the amount of filler can be reduced. Consequently, the flexible material properties can be maintained as far as possible. Several die concepts are presented and their influence on the thermal and mechanical properties of the pipe are compared.
A nanolayer coextruded optical film process was scaled up and optimized to show improvements in the thickness and compositional control at production level throughput rates. Adjustment of processing temperatures, implementation of online continuous gauging and automatic die lip adjusting equipment, and upgrades to the cast film pinning system led to improvements of film thickness control. A unique profile control scheme utilizing only the middle layer’s thickness instead of the total film thickness has been successfully utilized to control the critical layer’s thickness. Automation and optimization of the extruder’s feeding system provided compositional control capable of meeting tight quality specifications. With these improvements, production scale throughput rates of high-quality optical cast film capable for unique gradient refractive index (GRIN) optical applications were demonstrated.
With an aging global population growing, the demand for new healthcare products and telehealth systems will increase. The FDA aims to advance innovation and development in digital health while ensuring patient safety and effectiveness. Adhesives are critical in the new remote monitoring products, such as the small wearable devices that stick to skin. In addition, surgical adhesives are replacing stitches, and robotic surgical systems are rising. With healthcare adhesives, there are additional challenges in safety, performance, biocompatibility ISO 10993, and cost requirements. This paper reviews three healthcare adhesive trends: (1) topical skin adhesive patches, (2) tissue adhesives, and (3) medical device assembly and equipment adhesives.
Various grades of Thermoplastic Elastomer (TPE) were overmolded onto a FR-PC/ABS blend prepared with several different color recipes and tested for adhesion. All combinations prepared exhibited adhesive failure with a standardized peel test, yet showed relatively high average peak peel forces that ranged from 3.74-4.07 N/mm, which agreed well with literature values. Different color recipes for the substrate had no discernable effect on peel forces. Two-step overmolding of TPE using pre-molded (and therefore conditioned) substrates gave no significant difference to those prepared with direct 2-shot overmolding.
We tested an array of hospital surface disinfectants and cleaners for compatibility with several polycarbonate-based thermoplastic materials commonly used in healthcare equipment. To assess compatibility, we exposed tensile specimens to cleaners while under flexural strain, and then checked for cracking and tensile property retention. The results illustrate which cleaners are the harshest and which materials are the most chemically resistant. We also observed that periodic wiping and drying is frequently more damaging than the traditional test method of continuous wet exposure.
Increased demands on high-end materials focus the development on new functionalities such as biocidal effects, which are made possible by property changes in the nanoscale range of existing materials or by a combination of different material classes. Therefore nanoparticles, based on transition metal oxides have been synthesized in order to reach biocidal properties on plastic part surfaces. The influence of the nanoparticles on the thermal and mechanical properties have been characterized as well as the biocidal properties of the plastic part surfaces and of the nanoparticles itself.
Bioprinting, a subset of additive manufacturing, utilizes bioinks, which is a combination of biomaterials and live cells, to produce functional tissue. Soybean oil is a plant polymer with promising biomaterial properties for development as a bioink. Soybean oil is low cost, has excellent biodegradation, biocompatibility and low immunogenicity.Additionally, suboptimal soybean properties such as mechanical and bioactive properties can be altered and improved when combined with other polymers. The curing of resins formulated from a combination of soybean oil epoxidized acrylate and poly(ethylene glycol) diacrylate was investigated with different concentrations of the photoinitiator diphenyl(2,4,6-trimethylbenzoyl) phosphine oxide/2-hydroxy-2-methylpropiophenone, blend (DPH) and at different curing times. Visual observations of the cured resins indicated that as the photoinitiator concentration and curing time were varied, the resins exhibited changes in flexibility and rigidity / brittleness.
This paper presents the results of static short-term and long-term tensile tests for beta-nucleated joined polypropylene samples by the hot plate welding process. In the present study different dimensionless joining displacements are accounted for. The results show that high short-term tensile strength does not directly transfer to high long-term tensile strength. The morphology of the weld seam in the joined samples is examined by means of transmitted and reflected light microscopy. For the dimensionless joining displacements of 0.75 and 0.95, stretched spherulites are obtained. X-Ray diffraction can be used as a tool for qualitative and quantitative analysis and eventually for differentiation of samples of various joining displacements.
Spin welding is a common joining process for plastic parts with circular joints such as insulated cups and bowls, filter housings, and valves. In this process, heat is developed from surface friction as one part is revolved about the axis of the joint, resulting in a high linear speed. Finite element analysis (FEA) of the process can provide insight into potential mechanical deformation or failure under load that may compromise the weld, as well as aid in determining proper process parameters to achieve sufficient heating for a good weld. In this work, an approach to predict the weld temperature has been investigated and compared to measured results.
Tissue engineering using 3D scaffolds is an alternative to bone repair techniques that are currently used, such as autografts or allografts for bone non-union. Plasma irradiation is used as a sterilization method and can alter the surface topography of the scaffolds. We have prepared 3D scaffolds composed of poly(lactic-co-glycolic)acid (PLGA) and nanohydroxyapatite (nHA) using thermally– induced phase separation (TIPS) and 3D-plotting (3DP) techniques. We have also performed experiments to study murine stem cell adhesion to scaffolds that have been plasma irradiated. The scaffolds that were plasma irradiated with argon gas had ~140% more cell adhesion compared to untreated scaffolds.
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ANTEC 2016 - Indianapolis, Indiana, USA May 23-25, 2016. [On-line].
Society of Plastics Engineers
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