spectra M1 Isolated Fill & Finish Unit

Isolated Fill & Finish for small cGMP batches The spectra M1 is an isolated fill & finish unit, dedicated to small cGMP batches. SKAN Group As a member of SKAN, we combined our 20-year expertise and SKAN's state-of-the-art isolator technology to bring you this integrated isolated Filling System. Combining state-of-the-art technologies SKAN's most advanced technology, the spectra isolator, is CFR 21 Part 11 compliant and includes features such as the integrated SKAN nanox catalyst and skanfog to help optimize processes and guarantee fast and safe cycle times. With the AT-Closed Vial® technology...

your small batch processing The spectra M1 is used for aseptic filling of injectable drugs. Perfect for small production, it presents the following characteristics: Up to 150 AT-Closed Vial® per hour 0,1 ml to 50 ml filling High filling accuracy Single-use materials for product contact parts Tool-less format change CFR 21 PART 11 compliant (spectra) Suitable for Grade C/D production environment Integrated automated skanfog decontamination system Integrated SKAN nanox catalyst for H2O2 particules breakdown AT-Port™ for liquid transfer through the isolator wall

The spectra M1 is an easy-to-use manual filling equipment integrated within an isolator. In just three steps, you can fill the AT-Closed Vial®. 1. Filling —> The ready-to-fill AT-Closed Vial® is manually placed on its supporting base. —> Piercing of the stopper is accurately achieved by simple action on the lever. Filling is performed using a peristaltic pump. —> The vial is manually transferred into the laser safety cabinet. The laser control unit is activated via the embedded remote. —> The puncture trace is re-sealed by a 1 second laser shot on the stopper surface. —» Performed by simple snap-fit...

the best of both worlds The spectra M1 is composed of the best Aseptic Technologies Filling Station for small batches and SKAN’s most advanced isolator technology. It ensures safe and aseptic fill & finish operations. With its integrated elements and optional features, the spectra helps speed up your process operations and therefore overall efficiency. Combined with the M1 Filling Station and the AT-Closed Vial®, the spectra M1 ensures the safety and sterility of your operations. Our quality engagements Validation Master Plan A full Validation Master Plan with all tests related to the AT-Closed...

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