Contract manufacturer Freudenberg Medical has announced the launch of CleanAssure, a new ISO Class 5 controlled cleanroom designed to deliver clean and sterile single-use assemblies for biopharmaceutical customers.
The company said in a statement that the new, controlled cleanroom will enable customers to receive ready-to-use, washed, dried and gamma-sterilised 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 sterilisation 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 utilises ultrapure water and air while operating under tightly controlled ISO 5 conditions.
The ultrapure water is produced by a multi-stage filtration process specifically designed to meet high-purity standards for pharmaceutical applications.
Why this matters
Biopharmaceutical manufacturers are increasingly adopting single-use systems but face challenges with cleaning validation, contamination risk and production downtime.
Customer-managed cleaning processes can be time-consuming and costly, affecting supply reliability.
Freudenberg Medical is offering a controlled cleaning environment that will reduce cross-contamination risk, ease cleaning validation and minimise production downtime by eliminating cleaning as a process step.
The firm said that CleanAssure would be ideal for high-purity, contamination-sensitive applications where control and cleanliness are crucial.
Freudenberg will be exhibiting at INTERPHEX New York, April 21-23, Booth 1673.