In biopharmaceutical manufacturing, product quality starts with the right environment. We operate in controlled cleanroom environments that meet the high standards of the life sciences industry. This ensures consistent, reliable, and well-controlled production of custom single-use assemblies. Where applicable, the cGMP methodology is applied to further enhance quality and compliance.
Our facilities include two ISO 14644-1 Class 7 (in operation) certified cleanrooms and one ISO Class 8/9 (at rest) cleanroom.
The Class 7 cleanrooms are specifically designed for reliable, high-quality single-use assembly across a wide range of batch sizes. From small, specialized quantities to larger production runs, we can quickly adapt designs and support customers who manufacture under cGMP conditions.
In addition, the ISO Class 8/9 cleanroom is intended for integrating industrial components that cannot be processed in our standard cleanrooms. By keeping this environment separate, we can handle a broader variety of projects while still upholding the high quality standards of our Class 7 cleanrooms.
We’re proud to support our partners with cleanroom production at the highest standards. If you're interested in a tour or more information, please contact your UltraPure International partner. They’ll be happy to coordinate a visit together with us.
ISO Class 7 Cleanrooms – Flexible custom production
With a combined area of 140 m², our two ISO Class 7 cleanrooms are equipped to support a wide range of custom single-use assemblies The setup is ideal for both small batch production and larger volumes and ideal for customers that manufacture under cGMP conditions.
ISO Class 8/9 Cleanroom – For assemblies with industrial components
The third cleanroom is designed to process assemblies that include industrial components not compatible with our standard cleanrooms. This space provides the possibility to handle technically complex or hybrid assemblies, while maintaining the high quality standards in our ISO Class 7 cleanrooms.
The way our cleanrooms are set up reflects what makes UltraPure International stand out: the ability to produce custom single-use assemblies in both low and high volumes, with a strong focus on quality and flexibility.
Whether your project requires quick design modifications, small batch runs, or the integration of non-standard parts, we support it in a controlled, cGMP-aligned environment. With clearly defined procedures and purpose-built cleanroom spaces, we reduce risk, enhance consistency, and help your product move forward with confidence.
