Aseptic Fill Finish Solutions
High mix - low volume, Aseptic Fill Finish applications
Biological Pharmaceutical products, including vaccines, monoclonal antibodies, and other protein-based drugs are highly sensitive and this leads to specific considerations when specifying the filling technology utilized. In addition, Biologics often require a different production methodology that is driven by the need to handle batch sizes in the hundreds rather than thousands. Asset utilization is the key consideration in applications with small batches where agility becomes more important than production speed. These unique requirements necessitate careful consideration and a tailored approach to the specific aseptic filling process to ensure the highest standards in terms of flexibility and patient safety.
GMP compliant system
The combination of the proven Z-Lab filling technology from Rychiger and isolator technology from Block Technologies provides an Annex 1 compliant agile solution for aseptically filling vials. With a focus on rapid changeover, the Z-Cell solution is equipped with:
- Peristaltic pump technology
- Integrated load cell
- Environmental monitoring from Particle Measuring Systems
- Specially selected single use components and filling needles from Aseptcon
- PLC and servo motor control
Product integrity & protection
The Z-Cell solution assures gentle handling of sensitive biologic products whether produced on a laboratory or pilot production scale. Filling accuracy better than ±1% is achievable from micro volumes up to 50ml. The solution can produce 400 vials per hour and asset utilization is assured via smart design and recipe driven cGMP compliant control that can be connected to a supervisory system via OPC UA.
Product protection is guaranteed thanks to the EU GMP Class A (ISO Class 5) production chamber. The Isolator technology is scalable and customized around the user’s containment control strategy. The various options available include VHP, RTP, Mouse holes, de-contamination hatch, Glove testing, FMEA, etc.
From lab to automated production
The Z-Cell solution with integrated containment allows for optimum utilization when producing injectable products with high levels of order size complexity such as advanced therapy medicinal products (ATMPs) including cell and gene therapies (CGT).
The technologies used utilize the same components and controls that are found in the fully automatic Rychiger vial, syringe, and cartridge filling solutions. This facilitates a simplified scale up as production volumes grow.
Contact James to schedule a meeting at the Achema!