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Aseptic SKAN - Spectra M1 Aseptic Filling Unit
The Spectra M1 is an advanced isolated fill & finish unit specifically designed for small cGMP batches, integrating technologies from Aseptic Technologies and SKAN. It features SKAN's most advanced isolator technology, incorporating elements like the SKAN nanox catalyst and skanfog for optimized processes, ensuring rapid and secure cycle times. This unit employs the AT-Closed Vial technology in conjunction with the M1 Filling Station to enhance small-batch production efficiency. Its design ensures compliance with cGMP standards and offers a closed filling process from 0.1 ml to 50 ml. The bulk product is aseptically connected via the AT-Port System, which allows for external cooling and homogenization. Inside the chamber, vials are automatically filled and sealed with accuracy ensured by an integrated peristaltic pump and weighting cell. Continuous batch status tracking is displayed on a built-in screen. The system supports efficient decontamination cycles and includes a full Validation Master Plan.Combining state-of-the-art technologies from Aseptic Technologies and SKAN, the spectra M1 is an isolated fill & finish unit, dedicated to small cGMP batches.
SKAN's most advanced technology, the spectra isolator has elements such as the integrated SKAN nanox® catalyst and the skanfog® that help optimize processes and guarantee fast and safe cycle times.
Together with the AT-Closed Vial® technology and the M1 Filling Station, the spectra is designed to improve your small-batch production efficiency.
- cGMP compliant
- CCI ensured by design and validation of AT-Closed Vial®
- Filling from 0,1 ml to 50 ml
- Closed filling process
- Aseptic connection to bulk with AT-Port™
- No connection to HVAC
- CFR21 part 11 for spectra isolator
- Fast decontamination cycle with skanfog®
- Batch status tracking and recording
The spectra M1 contains the semi-automated AT-Closed Vial® filling process within the spectra isolator by SKAN.
The ready-to-use material (AT-Closed Vial® in AT-CryoBox™, AT-Cap™ in rigid support bases, fluid path AT-Filling Kit™) is introduced through a rapid decontamination airlock, the bulk product is passed directly to the main chamber through aseptic liquid connector, the AT-Port™ System, to keep the bulk outside of the isolator, where it can be cooled and homogenized.