Freudenberg Medical launches ISO Class 5 cleanroom, 'CleanAssure'

The cleanroom operates under stringent ISO Class 5 conditions, using ultrapure water and air systems

Freudenberg Medical has unveiled CleanAssure, a new ISO Class 5 controlled cleanroom designed to deliver washed, dried, and gamma-sterilized single-use assemblies for biopharmaceutical applications, strengthening its end-to-end manufacturing capabilities.

The facility supports high-purity, contamination-sensitive processes across vaccine production, cell culture, fluid transfer, and fill-finish operations. The company manufactures silicone and thermoplastic elastomer (TPE) tubing, along with seamless, overmolded assemblies widely used in bioprocessing.

“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 ensure a reliable supply.”

The cleanroom operates under stringent ISO Class 5 conditions, using ultrapure water and air systems. The water undergoes a multi-stage filtration process to meet pharmaceutical-grade purity standards, ensuring optimal cleanliness and sterility.