The first isolated fill & finish unit for small batches
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.
Designed in tight cooperation with users, Crystal® Pure M1 offers ergonomic and detail-oriented small batches processing.
Advantages
> Full cGMP compliance
> Fast decontamination cycle: less than 30 min
> Possiblity of plug-and-play installation and no connection to HVAC system
> Timesaving: validation package (including cleaning) provided with the equipment
Innovative decontamination
Innovative decontamination process SKANFOG®, used in Crystal® Pure M1, is based on the micro-nebulization of hydrogen peroxide (H2O2). Use of the catalytic converter, breaking the H2O2, allows a possibility of air exhaust directly in the room, decreasing installation requirements.
