At CPHI Barcelona 2023, Syntegon will showcase new developments for the filling and processing of small and micro batches. Equipment designed specifically for small batch sizes is in high demand not only for research and development, but also for the commercial production of liquid and solid pharmaceuticals. Visitors to booth 3S50 will see two innovations from Syntegon: Versynta microBatch and the TPR 200 Plus. In addition, the cloud-based software solution Synexio will be connected to Versynta microBatch.
Market launch: Versynta microBatch live on show
Following the first digital presentation of the new Versynta microBatch at Achema 2022, the official market launch will follow at CPHI Barcelona: “Pharmaceutical and biotech companies require increasingly flexible equipment for new, highly effective drugs, including new developments in cell and gene therapy, for ever smaller patient groups,” says Klaus Ullherr, Senior Product Manager at Syntegon. “Maximum product yield and fast changeovers are paramount, especially for very small batches. We will demonstrate how the Versynta microBatch meets these requirements live at our booth.”
The fully automated production cell, which already won the German Packaging Award in 2022, fills between 120 and 500 syringes, cartridges, and vials made of glass or plastic per hour with virtually no product loss and with 100 percent in-process control. Five integrated inline inspection systems ensure continuous process monitoring and provide particular safety by inspecting tubs, stoppers, and caps. Requirements of the new Annex 1 were also taken into account during development. For example, the gloveless isolator with integrated air management significantly reduces the risk of contamination. Optional network cameras facilitate continuous remote production monitoring in the isolator.
Synexio: demonstration and sneak preview
The cloud-based software solution Synexio is also on show at CPHI. It enables the collection, evaluation, and visualization of machine and production data. “In addition to the visualization of KPIs and machine availability and the identification of concrete improvement potential, visitors will get a first glimpse of the third Synexio package called ‘Empower’. It includes component monitoring, which we will demonstrate using specific use cases,” says Elisa Hein, Product Manager Expert Services at Syntegon. Synexio is part of Syntegon’s Service Agreements, which form the basis for effective equipment and maintenance management at fixed prices. “For new machines, we initially recommend level 4 from the seven available levels,” Hein explains. This includes all preventive maintenance work as well as training.
The new way of continuous direct compression
The trend towards small batches also accounts for the production of solid oral dosage forms. The Xelum platform offers continuous solutions, from fluid bed granulation to direct compression. In both cases, the same feeder-blender module can be used. In the configuration shown at the booth, the module doses and mixes individual packages, so-called X-keys. They ensure easy traceability and precise dosing, even and especially for active ingredients of less than 1%. Losses caused by starting and stopping are eliminated. The packages are continuously fed into the TPR 200 Plus tablet press, which enables efficient and user-friendly downstream processing. It features a light containment concept with dust-tight machine protection up to OEB 3. With the APD feeder, including automatically adjustable powder infeed in the filling shoe and the APD software, manufacturers can determine the optimum parameters for the formulation feed into the die.
SVP process systems: maximum flexibility
Versatility is a key characteristic of Syntegon’s portfolio for liquid pharmaceuticals. This includes the Pharmatec SVP process systems for the formulation of small- volume liquid pharmaceuticals in batch sizes from 13 to 3,000 liters, which will be displayed as 3D model at CPHI Barcelona. Thanks to their standardized modular design, the process systems can be adapted to a wide range of production needs. With the latest addition to its portfolio – the highly modular, fully automated SVP Essential – Syntegon offers pharmaceutical manufacturers a cost-effective alternative with maximum flexibility and short delivery times.