Freudenberg Medical, a Kaiserslautern, Germany-based contract design manufacturing partner, has launched CleanAssure, a new ISO Class 5 controlled cleanroom aimed at delivering clean and sterile single-use assemblies for biopharmaceutical customers. This initiative comes as the biopharmaceutical industry increasingly adopts single-use systems, which necessitate stringent cleanliness and sterility standards.
Freudenberg Medical specializes in manufacturing silicone and thermoplastic elastomer (TPE) tubing for critical applications such as vaccine production and fluid transfer. The introduction of CleanAssure allows the company to provide ready-to-use washed, dried, and gamma sterilized assemblies, significantly enhancing product quality and process consistency. Rudi Gall, VP of global pharma at Freudenberg Medical, emphasized that this service not only mitigates contamination risks but also streamlines validation activities, enabling clients to concentrate on their core manufacturing operations.
The controlled cleanroom environment is designed to address prevalent industry challenges, including cleaning validation and production downtime. By utilizing ultrapure water and air in compliance with ISO 5 conditions, Freudenberg Medical aims to alleviate customer burdens associated with cleaning processes, thereby ensuring a consistent supply of high-quality single-use assemblies. The company will showcase its new offerings at INTERPHEX New York, April 21–23, at Booth 1673, further underscoring its commitment to supporting the evolving needs of the biopharmaceutical sector.
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