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

 
New controlled cleaning and sterilization service supports biopharma customers with ready-to-use 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.

“CleanAssure allows us to support our customers beyond component manufacturing,” said Rudi Gall, Vice President Global Pharma at Freudenberg Medical. “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.”

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.

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.

Visit our Biopharma webpage to learn more.