Freudenberg Medical is moving deeper into the biopharma manufacturing value chain with the launch of CleanAssure for sterile single-use assemblies.
It is actually a new ISO Class 5 controlled cleanroom designed to deliver washed, dried, and gamma-sterilized single-use assemblies ready for immediate use.
The global medical device and biopharma contract design and manufacturing company said the new service is aimed at helping biopharmaceutical customers reduce contamination risks, simplify validation work, and improve supply reliability in high-demand production environments such as vaccine manufacturing, cell culture, and fill-finish operations.
Freudenberg Medical specializes in silicone and thermoplastic elastomer (TPE) tubing and complex overmolded single-use assemblies used in critical fluid transfer systems. With CleanAssure, the company is now bundling cleaning and sterilization into its manufacturing offering under tightly controlled conditions.
“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.”
The company said its cleaning process uses ultrapure water and air within ISO Class 5 conditions, supported by a multi-stage filtration system designed to meet pharmaceutical-grade purity requirements.
The launch comes as biopharma manufacturers increasingly rely on single-use systems but continue to face challenges around cleaning validation, contamination control, and production downtime.
Freudenberg said CleanAssure is designed to remove internal cleaning steps that are often resource-intensive and costly for customers.
According to the company, the service delivers three core advantages: reduced cross-contamination risk through controlled ISO Class 5 processing, elimination of customer cleaning validation burden through cGMP-validated cleaning and sterilization, and improved production efficiency by removing cleaning as a process step.
