- Freudenberg Medical has launched CleanAssure, an ISO Class 5 controlled cleanroom for clean and sterile single-use assemblies.
- The new service integrates cleaning and sterilization to support biopharma manufacturing and reduce contamination risks.
Freudenberg Medical has launched CleanAssure, a new ISO Class 5 controlled cleanroom designed to deliver clean and sterile single-use assemblies for biopharmaceutical customers. The facility supports the production of washed, dried, and gamma sterilized assemblies used across applications such as vaccine production, cell cultivation, fluid transfer, and fill-finish operations.
The company manufactures silicone and thermoplastic elastomer tubing for bioprocessing and critical fluid transfer. With CleanAssure, Freudenberg integrates controlled cleaning and sterilization into its offering, enabling customers to receive ready-to-use assemblies produced under tightly controlled ISO Class 5 conditions using ultrapure water and air.
“CleanAssure allows us to support our customers beyond component manufacturing. By integrating controlled cleaning and sterilization into our single-use assembly services, we help reduce contamination risk, streamline validation activities, and support a reliable supply for our customers.”
Rudi Gall, Vice President, Global Pharma at Freudenberg Medical
The launch addresses ongoing challenges in biopharma manufacturing, including cleaning validation, contamination risk, and production downtime. By delivering assemblies under validated cGMP conditions, the company aims to reduce customer burden associated with cleaning processes and support consistent supply.
CleanAssure is integrated with Freudenberg Medical’s broader capabilities in the design and manufacture of high-purity tubing, connectors, manifolds, and complex assemblies. The company also offers outsourced sterilization services, extending its role across the component value chain relevant to contract manufacturing in biopharma.
