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pure² M1
Description
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 pure² M1 is the first isolated fill & finish unit, dedicated to small cGMP batches.
The pure² M1 combines the AT-Closed Vial® technology and the isolator shell by SKAN pure² 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.
Features
- 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 HMI and filler HMI
Functioning principle
The pure² 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.
In the main chamber, the AT-Closed Vial® are 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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