CDMO partner Freudenberg Medical recently launched CleanAssure, an ISO Class 5 controlled cleanroom for sterile single-use assemblies.
The cleaning and sterilisation service supports biopharmaceutical manufacturers, which increasingly rely on single-use systems but face difficulties with cleaning validation, contamination risk, and production downtime.
“By integrating controlled cleaning and sterilisation into our single-use assembly services, we help reduce contamination risk, streamline validation activities, and support a reliable supply for our customers,” said Global Pharma VP Rudi Gall. “We can now support customers with their entire component value chain and allow them to focus on their core manufacturing capability.”
The controlled cleanroom enables customers to receive ready-to-use washed, dried and gamma sterilised single use assemblies. Freudenberg’s cleaning process uses ultrapure water and air. The water is produced using a multi-stage filtration process resulting in high-purity water specifically suited to pharmaceutical applications.
CleanAssure is suited for high purity, contamination-sensitive applications where control, traceability, and assured cleanliness are critical.
