AT-Closed Vial® and Container Closure Integrity during Cryogenic Storage
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spectra M1
Description
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. The filled vials in AT-CryoBox™ can be continuously brought outside of the isolator through a mousehole and an exit laminar airflow on the right.
Standard decontamination cycle for a maximal load, validated cleaning procedures and the full Validation Master Plan for the AT-Closed Vial® technology are provided.
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