AT-Closed Vial® and Container Closure Integrity during Cryogenic Storage
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pure 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 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.
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 beginner friendly
Functioning principle
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.
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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