Freudenberg Medical Launches CleanAssure™, an ISO Class 5 Controlled Cleanroom for Sterile Single-use Assemblies

Freudenberg Medical, a global contract design and manufacturing partner to the medical device and biopharma industry, announced the launch of CleanAssure™, a new ISO Class 5 controlled cleanroom designed to deliver clean and sterile single-use assemblies for biopharmaceutical customers.

Freudenberg Medical manufactures silicone and thermoplastic elastomer (TPE) tubing for bioprocessing and critical fluid transfer. The company specializes in seamless, overmolded single-use assemblies used in vaccine production, cell cultivation, fluid transfer, and fill-finish operations. The controlled cleanroom enables customers to receive ready-to-use washed, dried, and gamma sterilized single-use assemblies with the highest product quality, sterility, and process consistency.

Freudenberg's cleaning process uses ultrapure water and air, operating within tightly controlled ISO 5 conditions. The water is produced using a multi-stage filtration process resulting in high-purity water specifically suitable for pharmaceutical applications.

“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. We can now support customers with their entire component value chain and allow them to focus on their core manufacturing capability.” (Rudi Gall: Vice President, Global Pharma)

Addressing Key Biopharma Industry Challenges

Biopharmaceutical manufacturers increasingly rely on single-use systems but face ongoing challenges related to cleaning validation, contamination risk, and production downtime. Customer-managed cleaning processes are often time intensive, costly, and require additional resources while directly impacting supply reliability.

Freudenberg Medical’s controlled cleaning environment addresses these challenges by:

– Reducing cross-contamination risk through tightly controlled ISO Class 5 processing.
– Alleviating customer cleaning validation burden by delivering assemblies washed and sterilized under cGMP, validated conditions.
– Minimizing production downtime by removing cleaning as a process step.
– Supporting a consistent, reliable supply of high-quality single-use assemblies.

CleanAssure™ is suited for high purity, contamination-sensitive applications where control, traceability, and assured cleanliness are critical.

Freudenberg’s ISO Class 5 cleaning service is fully integrated with the company’s existing expertise in the design and manufacture of high purity tubing, connectors, overmolded sanitary ends, manifolds, T- and Y-molds, complex assemblies, and other ancillary products. Freudenberg also offers customers outsourced sterilization services.