Recipient Organization
ENERGYENE INC.
5659 CANAAN CENTER RD
WOOSTER,OH 44691
Performing Department
(N/A)
Non Technical Summary
High margin, low volume, specialty rubber product markets are critical to early stage commercialization of guayule natural rubber, a domestic rubber source. Current guayule production is too small to achieve economies of scale and cannot compete in the low cost, high volume, commodity markets. This project exploits the unique mechanical properties of guayule latex to develop the first radiation attenuation (RA) medical glove, a high performance/high value product. Existing RA gloves, made from latex tapped from the rubber tree, are classified as personal protective equipment, because the required loading of attenuation filler reduces glove mechanical properties below FDA medical glove performance requirements. FDA mandates that health care workers using ionizing radiation, double-glove with both an RA glove (to reduce their exposure to radiation) and a medical glove (to protect them from blood-borne pathogens) to the clear detriment of tactile sensitivity and patient outcomes. The intrinsic softness and elasticity of guayule latex allows combined high RA filler loading and glove performance that exceeds FDA requirements. A pair of natural latex RA gloves contains approximately 24g of natural rubber while commanding a price of $40-60/pair. Guayule RA medical gloves would certainly be positioned at the upper end of this range, because they could be used without double gloving and transmit a higher level of tactile sensation than current RA gloves (even without double-gloving). We can enter this market using our pilot plant capacity and demand is sufficient to support the construction of a commercial scale latex production facility with associated guayule acreage.
Animal Health Component
50%
Research Effort Categories
Basic
(N/A)
Applied
50%
Developmental
50%
Goals / Objectives
High margin, low volume, specialty rubber product markets are critical to early stage commercialization of guayule natural rubber, a domestic rubber source. Current guayule production is too small to achieve economies of scale and cannot compete in the low cost, high volume, commodity markets. This project exploits the unique mechanical properties of guayule latex to develop the first radiation attenuation (RA) medical glove, a high performance/high value product. Existing RA gloves, made from latex tapped from the rubber tree, are classified as personal protective equipment, because the required loading of attenuation filler reduces glove mechanical properties below FDA medical glove performance requirements. FDA mandates that health care workers using ionizing radiation, double-glove with both an RA glove (to reduce their exposure to radiation) and a medical glove (to protect them from blood-borne pathogens) to the clear detriment of tactile sensitivity and patient outcomes. The intrinsic softness and elasticity of guayule latex allows combined high RA filler loading and glove performance that exceeds FDA requirements. A pair of natural latex RA gloves contains approximately 24g of natural rubber while commanding a price of $40-60/pair. Guayule RA medical gloves would certainly be positioned at the upper end of this range, because they could be used without double gloving and transmit a higher level of tactile sensation than current RA gloves (even without double-gloving). We can enter this market using our pilot plant capacity and demand is sufficient to support the construction of a commercial scale latex production facility with associated guayule acreage.
Project Methods
The guayule latex matrix has more "room" to contain considerably more radiation attenuation filler than rubber tree latex (Hevea NRL) before failing the exam or surgeon's glove performance specifications. The linear structure of the rubber polymer and chemical nature of the non-rubber constituents of guayule latex (very low in total protein but high in fatty acids) allow higher filler loading.Our circumallergenic guayule thin glove filmswill be made with a xanthate based accelerator system, which exceeds the performance of guayule films achieved using conventional accelerators . We have demonstrated that three times the amount of biobased fillers can be contained within guayule rubber than in Hevea tree rubber. We will develop and validate guayule latex thin radiation attenuation, powder-free, lead-free, medical gloves, with an improved degree of attenuation by, combining two or three attenuating elements (none of them toxic lead, the traditional attenuating metal) to improve overall attenuation over a wide radiation output wavelength as specified in ASTM D7866 for radiation attenuation latex gloves. Gloves films will be made using two methods, one by mixing all ingredients together and the second by making emulsions of individual fillers and then mixing them together before dipping the films. Also, layering two attenuating filler emulsions will be tested to provide attenuation equivalent to pure lead but with less total weight, which is very difficult to achieve with any single layer of non-lead metal attenuator. The mechanical performance of GNRL films of five thicknesses (from five dwell times in the latex) will be tested at five filler loadings, using samples prepared using an aluminum dipping plate. This will result in 25 combinations of filler loading and dwell time for each filler compound, and 100 film varieties. Since we will be using dipping plates to generate test film samples, each dip produces two identical films samples, one from each side of the plate. The thickness of both films is measured and the tensile properties of the films determined, according to ASTM D412. Film samples that meet or exceed the physical properties required by the examination glove standard ASTM D3578, will be tested for radiation attenuation. In addition, the relationship of film thickness with loading and dwell time will be determined and used to inform subsequent experimental designs. The findings (outputs) from this objective also will allow selection between the micro or nano size of attenuation filler material for the remaining studies. We will then determine the impact of combining attenuation fillers in mixed dispersions and in laminated films with attenuating fillers in different layers of the glove films. This design will result in five ratios of two attenuators for each method (layered & homogenous), and a total of 10 film types. Unlike objective 1, two dipping plates will be used for each compound. This will provide four identical films of each film type, one of which will be used to determine physical properties (in quadruplicate), and three of which will provide triplicate radiation attenuation results, which will be statistically analyzed. The attenuation capacity of laminated films will be tested in both directions, to determine if layer order alters the degree of attenuation. In addition, a third attenuating metal will be tested to see if additional attenuation can be achieved. In sum, nine levels of attenuator ratio variations will be tested for each manufacturing method. All samples will be attenuation- tested in triplicate, in the direction determined earlier. In addition, the samples will be retested for physical performance to determine the degree to which radiation exposure affects their film properties, if at all. The attenuation, thickness and mechanical performance will then be optimized. The radiation attenuation glove standard (D7866) mandates a lower level of attenuation than currently achieved by the commercially available gloves With the final optimized formula(e), we will make 15 glove samples at the minimum thickness required to exceed this standard by 10%. In addition, we will make 15 gloves at the minimum thickness needed to match the average attenuation of the commercially available RA gloves. These gloves will be submitted, together with commercially available glove samples, for attenuation testing. As required by ASTM D7866, 5 gloves will be selected randomly from the 15 gloves, each glove will be cut into 5 cm x 5 cm square at the thinnest part and tested for radiation attenuation strictly following the attenuation testing standard ASTM F2547. An official ASTM report will be generated. In addition, the samples will be retested for physical performance to determine the degree to which radiation exposure affected their film properties.Films made with the new formulation(s), with and without optimal loading of radiation attenuation materials, will be subjected to the repeated patch test of Buehler, ISO 10993-10, as is standard for solid test articles. Tests will be performed at a licensed testing facility, such as AppTec Laboratory Services, St. Paul, Minnesota, USA. These data supports the FDA 501k applications to (a) can approval for films containing the new accelerators and (b) use of the radiation attenuation fillers in such films.