Freudenberg Medical has launched CleanAssure, an ISO Class 5 controlled cleanroom service for sterile single-use assemblies used in biopharmaceutical manufacturing. The service adds controlled washing, drying, and gamma sterilisation to the company’s existing component and assembly offer, with the aim of supplying ready-to-use assemblies for contamination-sensitive applications.
Freudenberg Medical manufactures silicone and thermoplastic elastomer tubing, along with seamless overmoulded single-use assemblies used in vaccine production, cell cultivation, fluid transfer, and fill-finish operations. CleanAssure extends that work into controlled cleaning under ISO 5 conditions using ultrapure water and air, creating a more complete route from component manufacture to sterilised finished assembly.
The launch addresses a persistent operational issue in biopharma production. Single-use systems are widely used, but customer-managed cleaning can add time, cost, documentation burden, and another point of process risk. By delivering assemblies that have already been washed, dried, and sterilised under validated cGMP conditions, Freudenberg is aiming to reduce contamination exposure and remove one more step from the customer’s own process chain.
The service is positioned for high-purity applications where traceability, control, and cleanliness are tightly specified. Freudenberg says the cleanroom process helps reduce cross-contamination risk, ease cleaning validation burden, and minimise production downtime by removing in-house cleaning as a required step before use.
CleanAssure also moves the company further up the value chain. Freudenberg already supplies high-purity tubing, connectors, sanitary ends, manifolds, moulded components, and complex assemblies, and also offers outsourced sterilisation services. Adding controlled cleanroom processing consolidates more of that pathway inside a single supplier environment, which may appeal to customers seeking tighter supply control across critical process components.
Freudenberg Medical is presenting the new service at INTERPHEX New York, running from April 21 to 23, where it is showcasing the cleanroom capability alongside its wider biopharma manufacturing offer.
