Crystal -Model pure M1 -Aseptic Filling System
The pure M1 is an advanced aseptic filling system designed specifically for small cGMP batches in the biopharmaceutical industry. Developed in collaboration with SKAN and end-users, it integrates the AT-Closed Vial technology with an innovative isolator design from SKAN pure Solutions. This system allows for aseptic filling without cumbersome installations, as it requires no connection to HVAC systems. Its ergonomic, space-saving configuration includes a manual filling equipment within an isolator, a rapid material airlock, and an exit laminar airflow. It utilizes H2O2 for fast decontamination cycles, ensuring validated cleaning procedures and enhanced safety. This plug-and-play equipment is equipped with a semi-automated filling process that employs a peristaltic pump for precision and an integrated weighting cell for easy calibration. The pure M1 facilitates streamlined production and can serve as an introduction to isolator technology on manufacturing sites, providing an effective solution for filling requirements in controlled environments.
The pure M1 contains the semi-automated AT-Closed Vial® filling process within the pure 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.
The use of an isolator for biopharma manufacturing keeps on trending, since it implies lower installation requirements and strong reduction of contamination, by creating a controlled environment and decontamination of the material, operating chambers and equipment.
Result of collaboration between Aseptic Technologies, SKAN and our users, the pure M1 is the first isolated fill & finish unit, dedicated to small cGMP batches.
The pure M1 combines the AT-Closed Vial® technology and the isolator shell by SKAN pure Solutions. It consists in an isolator with integrated manual filling equipment, rapid material airlock and an exit laminar airflow.
The overall design was performed in tight cooperation with end-users, resulting in deep understanding of the processes involved and providing an ergonomic solution.
- Ergonomic and space saving design
- Pre-engineered process
- No connection to the HVAC system
- Filling from 0,1 ml to 50 ml
- Aseptic connection to bulk product
- Single-use material only
- Fast decontaminations cycles
- Innovative H2O2 decontamination
- Batch status tracking and recording
- Continuous finished product exit
- Validated cleaning
- Isolator beginner friendly