Freudenberg Medical launches ISO Class 5 cleanroom for assemblies

The CDMO’s service provides pre-cleaned and sterilized single-use assemblies to reduce contamination risk and streamline validation in bioprocessing operations.

April 21, 2026

Cleanroom CleanAssure from Freudenberg Medical

Freudenberg Medical, a global contract design and manufacturing organization (CDMO) for medical device and biopharma applications, announced the launch of CleanAssure, an ISO Class 5 controlled cleanroom for production of sterile single-use assemblies.

The new cleanroom reportedly enables delivery of washed, dried, and gamma-sterilized assemblies used in bioprocessing, including applications in vaccine production, cell culture, fluid transfer, and fill-finish operations. The company said the controlled environment is designed to support contamination-sensitive manufacturing processes by ensuring high levels of cleanliness and consistency.

According to the CDMO, the cleaning process uses ultrapure water generated through multi-stage filtration, along with controlled air conditions, to meet pharmaceutical-grade requirements. The service integrates cleaning and sterilization into the manufacturing workflow, allowing customers to receive ready-to-use components.

Freudenberg said the offering is intended to reduce contamination risk, eliminate the need for in-house cleaning validation, and minimize production downtime. By removing cleaning as a separate step, the approach supports more streamlined operations and improved supply reliability for single-use systems.

The service is integrated with the company’s existing capabilities in high-purity tubing, overmolded assemblies, and fluid management components, enabling end-to-end support for single-use manufacturing systems, the company said.

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