Our Single Use Systems are produced by trained personnel in a valid ISO Class 7 facilities. Employee hygiene, gowning and continuous monitoring of clean room environment are an essential part of these processes.

Our quality management system emphasizes Quality by Design (QbD) along with end product testing, and comply with the ISO-9001:2015 and ISO-13485:2016.

All our processes are subjected to a robust risk management procedures, validated and continuously monitored after product realization to ensure that the products meet their predetermined specifications and applicable regulatory requirements.