Crystal® PURE M1The first isolated aseptic filling unit ■ Dedicated to small batches ■ Designed for novel therapies ■ Combines novel isolator technology and AT-Closed Vial® filling

The first plug-and-play isolated aseptic filling unit Result of over 10 years of Aseptic Technologies’ experience in setting-up the cGMP aseptic filling process for novel therapies and deep knowledge of user’s requirements, Crystal® Pure M1 is a complete fill & finish solution, neatly combining the AT-Closed Vial® Technology and a new generation of isolator by SKAN. Crystal® Pure M1 ensures full cGMP compliance, smooth validation and overall cost of goods reduction for small and extra-small batches. Main features Ergonomic arrangement and integration of each element of the unit was performed...

Small batch operation A manual filling station operating with AT-Closed Vial® is integrated in the main chamber of the Crystal® M1 Pure. Overall operation, as for every AT-Closed Vial® Technology filling line, consists of filling the vials through the stopper by piercing it with a special needle, restoring the closure integrity with a laser shot and capping with a snap-fit capsule. All the necessary elements are ergonomically embedded in the working area of isolator: - a filling unit and its stainless-steel peristaltic pump with an integrated weighting cell, allowing effortless dose calibration;...

No connection to the HVAC system needed The exhaust air can be rejected directly to the room, thanks to the use of a SKAN NANOX® catalyst breaking the H2O2 AT-Port™ System The bulk product is kept outside the isolator, saving space. The aseptic connection ensures minimal dead volume. Space saving design The compact design allows the bringing-in through standard doorways and elevators. Manual filling line Operating with AT-Closed Vial®, remaining closed throughout the process, minimizing contamination risks and guaranteeing no product exposure to the residual H O . Continuous material entry Rapid...

Batch status tracking and recording The batch status is tracked and visualized by operator thanks to a LED screen in the back of the main chamber Innovative decontamination technology Fast, reproducible and validated decontamination cycle and material transfer with micro-nebulization of H2O2 (SKANFOG® Cloud™ technology) Continuous product exit Filled vials are moved out of the main chamber through a mouse-hole to the exit LAF, to be exited from the isolator for further processing, continuously. Easy cleaning The exterior materials are durable and resistant. The internal part and its equipment...

Innovative Decontamination Micro-nebulization method SKANFOG® decontamination process is a decontamination technology based on the micronebulization of hydrogen peroxide (H2O2). Nebulized H2O2 in moderate concentrations can be used without concern regarding toxicity, corrosion and persistence. Total kill is achieved faster By micro-nebulizing H2O2 directly in the chamber The aeration (down to 0.5 ppm) is faster Unlike with Vaporized Hydrogen Peroxide (VHP), the filter is not saturated with H2O2 < 30 min Total decontamination cycle duration with Crystal® Pure M1 Fast decontamination The decontamination...

Dimensions Weight Utilities H2O2 type Materials Operation pressure Air velocity down flow Exhaust (double filtered) Filter type to airlock H2O2 catalyst Bulk connection Filling volume Filling accuracy Product Path Control system Interfaced Noise level Light Aseptic filling of liquid parenterals, including - Autologous and allogeneic cell therapy; - Gene therapy; - Intermediate Products for Cell and Gene Therapy (viral vectors, plasmid DNA, working and master cell banks…); - Immunotherapies; - Compounding pharmacy; - Individualized or small batch production. L 3300 x W 982 x H 2272 mm ca. 650...

Aseptic Technologies, member of SKAN Group, is engaged in long-term mutually beneficial partnerships with first class companies that provide us with their respective resources, expertise and products ^•asepticTECHNOLOGIES Parc Scientifique CREALYS Rue Camille Hubert, 7-9 B-5032 Gembloux-Les Isnes Belgium Member of SKAN Group