MDI quality management system emphasizes on quality by design along with end product testing. Robust processes are developed for product manufacturing and are continuously monitored to ensure that the products meet their predetermined specifications and lot to lot reproducibility is ensured.
MDI Single Use Systems are produced by trained personnel in validated ISO class 7 facilities using validated production processes.Employee hygiene, gowning and continuous monitoring of clean room environment are an essential part of these processes.
Each lot has well compiled batch manufacturing records thatensure complete traceability of raw materials, machines, in-process controls, personnel and quality control test data.
These are tested and validated as per international standards and guidelines such as CFR, ASTM, ISO and USP and supported by well designed, state of the art physical, chemical and microbiology laboratories.