Aseptic SKAN - Spectra M1 Aseptic Filling Unit
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.
