[Image courtesy of Freudenberg Medical]
The service, branded CleanAssure, is pitched at biomanufacturers looking to push more of the cleaning and sterilization burden upstream to their component suppliers. Freudenberg Medical, a CDMO that produces silicone and thermoplastic elastomer (TPE) tubing along with overmolded single-use assemblies for vaccine production, cell cultivation, fluid transfer, and fill-finish, said the new line uses ultrapure water produced via multi-stage filtration along with controlled air under ISO 5 conditions.
“CleanAssure allows us to support our customers beyond component manufacturing,” Rudi Gall, Vice President Global Pharma at Freudenberg Medical, said in a statement. “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
A press release describes the service as fully integrated with Freudenberg’s “design and manufacture of high purity tubing, connectors, overmolded sanitary ends, manifolds, T- and Y-molds, complex assemblies, and other ancillary products.” The company also provides customers outsourced sterilization services.
The launch lands against a broader shift in biopharma manufacturing. Single-use systems (SUS) have largely displaced stainless steel in new-build capacity for cell therapy, monoclonal antibody, and vaccine production, in part because disposable, pre-sterilized flow paths eliminate clean-in-place and sterilize-in-place steps between batches. But as the industry leans harder on SUS, the validation responsibility has shifted rather than disappeared. Regulators expect manufacturers to demonstrate full material traceability for every component that contacts process fluids, and preassembled or multi-supplier configurations can increase the validation burden rather than reduce it.
Freudenberg will exhibit the new service at INTERPHEX booth 1673.
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