Aseptic filling isolator for small cgmp batches
In biopharma manufacturing, ensuring a contamination-free environment is crucial, particularly when handling small GMP batches. Traditional cleanroom setups often struggle with high installation costs and complex maintenance, which can hamper process efficiency and product integrity.
Achieve aseptic filling with manual precision.
The pure M1 by Aseptic Technologies is an isolated fill and finish unit specifically designed for small cGMP batches. It incorporates the AT-Closed Vial® technology within an isolator shell from SKAN pure Solutions. This system includes an isolator with an integrated manual filling process, a rapid material airlock, and an exit laminar airflow. Developed in collaboration with end-users, the pure M1 provides an ergonomic and space-saving solution tailored to the specific needs of aseptic manufacturing. Capabilities include filling volumes from 0.1 ml to 50 ml and utilizing single-use materials only, ensuring a contamination-free process. The AT-Port™ system maintains bulk products outside the isolator, facilitating cooling and homogenization. The semi-automated filling process uses a peristaltic pump for high dosing accuracy, complemented by a built-in weighing cell for easy calibration. Real-time batch status is shown on a screen inside the isolator chamber, and filled vials can exit continuously through a mousehole and laminar airflow.
Benefits
- Reduces contamination risk with integrated isolator technology.
- Handles small batch sizes efficiently, from 0.1 ml to 50 ml.
- Employs single-use materials to avoid cross-contamination.
- Provides real-time batch status monitoring for better control.
- Facilitates process integration with ergonomic design.