Biological pharmaceutical products, including vaccines, monoclonal antibodies, and other protein-based drugs, are highly sensitive and are often produced in small batch sizes. This necessitates specific considerations when choosing the filling technology. Rychiger Pharmatech combines the proven Z-Lab filling technology and the isolator technology from Block Technologies for the small batch production of biopharmaceuticals. The system, called Z-Cell, is an an Annex 1 and GMP compliant agile solution for aseptically filling vials. With a focus on rapid changeover, the solution is equipped with the following:
- Peristaltic pump technology
- Integrated load cell
- Environmental monitoring from particle measuring systems
- Specially selected single-use components and filling needles from Aseptconn
- PLC and servo motor control
- cGMP-compliant documentation
The Z-Cell solution with integrated containment allows for optimum utilisation 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 found in the fully automatic Rychiger Pharmatech vial, syringe, and cartridge filling solutions, facilitating a simplified scale-up as production volumes grow.
The Z-Cell solution ensures gentle handling of sensitive biologic products, whether produced on a laboratory or pilot production scale. It can achieve filling accuracy better than ±1 % from micro-volumes up to 50 ml. The solution
can produce 400 vials per hour, and asset utilisation 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 customised around the user’s containment control strategy. Various options include VHP, RTP, mouse holes, decontamination hatch, glove testing, FMEA, etc.
The Rychiger documentation team provides ready-to-use qualification protocols that can validate that the equipment will offer a high degree of quality assurance for the products manufactured. dh
Rychiger Pharmatech
Hall 3,0, Booth B25
