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USS Background
We have over 140 years of professional experience in FDA regulatory agencies and academia, pharmaceutical and medical packaging processes, thermal, liquid and gas sterilization methods, and plasma and electron beam (EB) irradiation sterilization techniques. Our low voltage sterilization concept was introduced over two decades ago to a key global European aseptic food packaging company, which now has over 500 EB units running in the field. In the medical and pharmaceutical industries, higher SAL values are required and EB voltage and dose levels are custom tailored for each product.
Business Model
Our business model is "a specific process for each product". It is based from years of experience in innovating and networking with leaders in the industry (over 300) from key medical and pharmaceutical companies. Once we define a process from customer specifications, we procure the parts from key suppliers of EB (from 10 kV to 5 MV) sources, robotics, conveyors, vacuum systems, plastics, materials, facilities, etc. and integrate the equipment to an in-line manufacturing process or an off-line in house or contract facility operation.
Customer Committment
Our commitment to our customers is to determine the optimum sterilization process for each specific product, and build, consult, or operate the equipment, process, or facility at the most cost effective means possible.
Universal Sterilization Sciences, LLC
Universal Sterilization Sciences, LLC (USS) was launched in 2016 to address the Sterility Assurance Level (SAL), regulatory issues, and technological advancements in the manufacturing of medical devices, Pre-Filled Syringes and new complex combination products in the medical and pharmaceutical industries.
Our goal is to derive the optimum sterilization process for each specific device based on product specifications for sterility, packaging, and throughput. Using gas sterilization as a baseline, we use our system integration and novel technology skills to develop the next generation of aseptic processing techniques. This will happen through novel processes,products, microbiology and new dosimetry, reprocessing, and unique terminal sterilization methods.
Our business model is tailored for each customer and each product.
