Continuous filling machine Crystal® PURE M1

for liquidsfor vialsfor the pharmaceutical industry

The use of an isolator for biopharma manufacturing keeps on trending, since it implies lower installation requirements and strong reduction of contamination, by creating a controlled environment and decontamination of the material, operating chambers and equipment. Result of collaboration between Aseptic Technologies, SKAN and our users, the pure M1 is the first isolated fill & finish unit, dedicated to small cGMP batches. The pure M1 combines the AT-Closed Vial® technology and the isolator shell by SKAN pure Solutions. It consists in an isolator with integrated manual filling equipment, rapid material airlock and an exit laminar airflow. The overall design was performed in tight cooperation with end-users, resulting in deep understanding of the processes involved and providing an ergonomic solution. Features Ergonomic and space saving design Pre-engineered process No connection to the HVAC system Filling from 0,1 ml to 50 ml Aseptic connection to bulk product Single-use material only Fast decontaminations cycles Innovative H2O2 decontamination Batch status tracking and recording Continuous finished product exit Validated cleaning Isolator beginner friendly Perfect for The pure M1 is a plug and play equipment addressing the needs of aseptic filling of small and extra-small batches of in GMP environment. It is designed to facilitate the introduction of the isolator technologies on the manufacturing site or to bring the fill and finish activities in-house. Functioning principle The pure M1 contains the semi-automated AT-Closed Vial® filling process within the pure isolator by SKAN.