Liquid filling machine spectra M1

for vialsasepticwith isolator

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. Features 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 Functioning principle 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. In the main chamber, the AT-Closed Vial® is semi-automatically filled, laser re-sealed and capped with a snap fit. The dosing system, a peristaltic pump, provides high accuracy and is easily calibrated thanks to an integrated weighting cell. Overall batch status is demonstrated live on the built-in screen in the back of the isolator chamber.