The pharmaceutical industry is one of the most highly regulated markets in the world, focused on ensuring product purity, process integrity, and patient safety at every stage of drug development and manufacturing. From intravenous solutions and dialysis fluids to transdermal products and sterile injectables, pharmaceutical companies and contract manufacturers depend on fluid transfer solutions that maintain the highest standards of cleanliness, consistency, and regulatory compliance.
Hoses and tubing assemblies in pharmaceutical manufacturing must meet rigorous standards to protect against contamination and ensure product quality. Materials are required to meet USP requirements, be plasticizer-free, and in some cases be manufactured under strict cleanroom conditions. Compliance with sterility requirements such as ISO 11137 and adherence to FDA regulations are essential. Additional performance requirements include consistent wall thickness, chemical resistance, flexibility, and the ability to withstand high-purity applications without imparting taste, odor, or leachables. Traceability of raw materials and robust quality systems are also mandatory to meet the demands of pharmaceutical regulators and manufacturers alike.
Ace Sanitary provides a complete line of single-use and multi-use hose solutions engineered to meet the demanding requirements of the pharmaceutical industry. Our single-use assemblies are manufactured and assembled in our Cincinnati, Ohio facility within ISO Class 7 cleanrooms, ensuring sterility and compliance with no minimum order requirements. This flexibility allows us to support projects of all sizes while meeting strict industry standards.
Our in-house vertical extrusion of platinum-cured silicone tubing is a unique innovation that delivers unmatched purity, uniform wall thickness, and exceptional customization. The Flex-Rite™ A-Series specialty tubing extends our portfolio with high-purity options made from TPE, TPR, PVC, LDPE, PTFE, and platinum-cured silicone. Each product is USP compliant, plasticizer-free, and engineered for critical applications including intravenous solutions, dialysis with purified water, biopharmaceutical transfer, and transdermal manufacturing.
Beyond single-use products, Ace Sanitary manufactures multi-use silicone and PTFE hoses that provide long-term durability and resistance to aggressive cleaning regimens. Our proprietary Flex-Rite™ silicone hoses are extruded and platinum-cured in cleanroom environments using pharmaceutical-grade materials with complete traceability, ensuring seamless performance and reliability.
Ace Sanitary is more than a hose supplier—we are a trusted partner to the pharmaceutical industry. Our expertise in cleanroom manufacturing, material science, and regulatory compliance ensures that every product we deliver supports process integrity and patient safety. We operate with speed, offering rapid delivery on standard products, no minimum order quantities, and responsive lead times to keep production on track. And we emphasize simplicity, providing straightforward solutions, flexible customization, and a customer-first approach that reduces complexity in an already demanding industry.
From single-use tubing assemblies to multi-use silicone and PTFE hoses, Ace Sanitary provides a complete range of solutions that meet the purity, compliance, and performance requirements of modern pharmaceutical manufacturing.
To find out more about Ace Sanitary’s Vertical Extruded, Platinum Cured Silicone Tubing, click here.
