Our Single Use Systems are made by skilled staff in certified ISO Class 7 cleanrooms. Strict employee cleanliness, protective clothing, and ongoing cleanroom condition checks are crucial in our production.

Our quality management focuses on Quality by Design (QbD), coupled with final product testing, and adheres to ISO-9001:2015 and ISO-13485:2016 standards.

We rigorously evaluate risks, validate, and consistently oversee all processes after product completion, ensuring they meet predefined specifications and relevant regulatory standards.