May 11, 2022
The isolator is designed to guarantee an aseptic environment where a small filling line is used for the filling and stoppering of vials.
- Introduce vials and tools in the airlock
- Run a decontamination cycle for both the airlock and the working chamber to ensure sterility during operations
- Move the vials and tools to the working chamber where they are opened
- The integrated filling line fills and closes the vials
- Remove the vials from the isolator through a rapid transfer port
What are the issues?
- How to guarantee aseptic conditions inside the isolator and the filling machine?
- How to ensure the sterility is maintained throughout the process?
- How to make the filling line completely accessible for both operations and maintenance?
Benefits of FPS Solution:
- VHP decontamination system and hydrogen peroxide sensors are integrated in this isolator to ensure sterility
- Integrated air sampler and particle counter monitor the sterility level inside the isolator
- Working chamber designed to integrate the filling line
- Isolator design and glove stretchers ensure that all surfaces are reached by the VHP
- Material transfer system to keep the isolator aseptic when material and waste are removed
Description of FPS custom solution:
The rigid wall isolator is composed of an inlet airlock, where the tools and vials are introduced and decontaminated as well as a main working chamber where the filling line is integrated.
A decontamination system uses vaporized hydrogen peroxide to guarantee the sterility of the chambers and the ventilation system maintains a positive pressure regime to prevent any external contamination from entering the isolator.
The vials are filled in the main working chamber by an integrated small filling line. At the end of the operations, the vials are removed through a rapid transfer port installed on the side wall of the working chamber.
Custom solution highlights:
- Vaporized hydrogen peroxide sensors and an air sampler and particle counter installed in the chambers help to guarantee an aseptic (Grade A) environment
- A positive pressure regime guarantees that no external contamination can enter the isolator. The pressure inside the working chamber is higher than the airlock and both are higher than the external environment
- Rails and hooks are provided inside the working chamber to hang/support tools and material
- The control system is capable of recording audit trails and storing the data on a network
- A semi-automatic glove tester is used to check the glove integrity and identify possible leaks