Freudenberg Medical Launches CleanAssure Cleanroom for Sterile Single-Use Assemblies

Freudenberg Medical is launching CleanAssure, its new International Organization for Standardization (ISO) Class 5 controlled cleanroom. Freudenberg, a global CDMO, says the cleanroom’s design delivers sterile, single-use assemblies for its biopharmaceutical customers.

Advantages of the CleanAssure Cleanroom

The company says CleanAssure suits high-purity and contamination-sensitive applications—owing to the criticality of control, traceability, and assured cleanliness. The cleaning service integrates with Freudenberg’s existing expertise in design and manufacture of tubing, connectors, and various other ancillary products.

According to Freudenberg, single-use systems present challenges such as cleaning validation, contamination risk, and production downtime. When managed by the customer, cleaning processes can be time-intensive, costly, and use extraneous resources while jeopardizing supply reliability.

The controlled cleaning environment of CleanAssure, by contrast, reduces contamination risk via tightly controlled ISO Class 5 processing. Freudenberg deploys ultrapure water and air in the cleaning process, with the water produced by multi-stage filtration.

Freudenberg’s Goals for Customers

Altogether, this alleviates customers’ burden of cleaning validation by washing and sterilizing assemblies under current good manufacturing practice (cGMP) conditions.

Additionally, with cleaning removed as a process step, production downtime is minimized. These steps support a consistent and reliable supply of high-quality single-use assemblies, according to Freudenberg.

“CleanAssure allows us to support our customers beyond component manufacturing,” said Rudi Gall, Freudenberg Vice President, Global Pharma. “We can now support customers with their entire component value chain and allow them to focus on core manufacturing capability.”

Freudenberg Medical specializes in seamless and overmolded single-use assemblies used in vaccine production, cell cultivation, fluid transfer, and fill-finish. The company is a manufacturer of silicone and thermoplastic elastomer tubing for bioprocessing and critical fluid transfer.