Aseptic filling solution for small cgmp batches
In environments where small cGMP batch production is essential, maintaining sterility and speed during the fill and finish process poses significant challenges. Ensuring that components remain free from contamination while achieving rapid cycle times is critical for success.
Optimize your aseptic filling process
The spectra M1, offered by Aseptic Technologies in collaboration with SKAN, is an advanced isolated fill & finish unit specifically designed for small cGMP batch production. This system features the highly regarded SKAN nanox® catalyst and skanfog® technology, which work together to ensure fast and safe decontamination cycles. Utilizing the AT-Closed Vial® technology and the M1 Filling Station, the spectra M1 significantly boosts production efficiency by maintaining a closed filling process, which avoids contamination. The filling process accommodates volumes ranging from 0.1 ml to 50 ml and employs a peristaltic pump with an integrated weighing cell for high accuracy. The user can monitor batch status in real-time via the built-in screen, and the overall operation is compliant with CFR21 part 11 standards. Ideal for applications in cell and gene therapy, next-generation biologics, and compounding.
Benefits
- High accuracy with peristaltic pump and integrated weighing cell
- Fast decontamination cycle with advanced skanfog® technology
- Ensured sterility through closed filling process
- Live batch status monitoring on built-in screen
- Compliance with CFR21 part 11 standards