SBIR Phase I: A System for Representative Sampling of Powder Blends in Pharmaceutical Manufacturing

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be realized first in pharmaceutical manufacturing where powder blends are needed to make tablets. These tablets constitute 40% of the most profitable pharmaceutical products, and nearly 80% of commercial products. The proposed device (sampler) will protect employees in pharmaceutical plants from exposure to potentially toxic drugs. The sampler will also be suitable for industrial powder blends such as vitamins, nutraceuticals, powdered milk, and other food products. The sampler will improve quality control in these companies and lead to representative sampling, thereby reducing risk to customers and patients. Sampling errors, which are frequent with the current approaches, will be reduced, increasing industrial productivity and avoiding production delays. The new sampler will have a positive financial impact in a number of powder processing industries and at the same time improve product quality. The proposed project will provide funding to design devices to sample powder mixtures. The first work will be with the powder blends that become the tablets that many patients require. These new samplers are needed because the current practice in the pharmaceutical industry consists in inserting a spear into 10 - 12 pre-selected locations, which will not detect over or sub-potent blends outside of these locations. In contrast the new sampler will obtain a cross-section of a flowing powder, and all parts of the blend have the same possibility of being selected as a sample. The new device will be based on concepts first established within the mining industry, which have not been adapted to the pharmaceutical and powder industries. Experimental and computational methods will be used to design the new sampler, which will make it possible to implement statistical methods to assure representative sampling. The research team will work to provide a commercial sampler and support services to avoid delays in the introduction of new products and help pharmaceutical companies grow to obtain new revenues in less time.