Syntegon Technology has developed a portfolio for small and micro batch applications under the name Versynta. The modular small batch solution is an individually configurable machine with an integratable isolator for filling aseptic and highly potent liquid active ingredients.
Versynta FFP stands for flexible filling platform. "We offer pharmaceutical manufacturers, R&D laboratories and biotech startups a combination of standardisation and high modularity with short delivery times," said Klaus Ullherr, Senior Product Manager at Syntegon. The platform reportedly processes up to 3,600 containers per hour and comes with 100% in-process control.
The product can be converted to different container types such as vials, syringes, and cartridges, as well as different filling systems including single-use solutions. Instead of entire modules however, only format parts need to be replaced. In addition, the platform offers the possibility of vacuum-free high-potent vial processing. The Pharma Handling Unit, a four-axis robot developed by Syntegon, is designed to enable safe transport. It transfers the containers from one station to the next without glass-to-glass contact. The laminar flow-optimised design means the air flow can reach the containers and flow around them without obstruction, Syntegon says.
"Syntegon is primarily known for medium and high-performance lines. However, we can also look back on many years of experience and more than 60 successful customer references in the small batch sector," said Crailsheim Site Manager Dr. Alexander Giehl. "Versynta now bundles this experience. Our complete portfolio covers the entire pharmaceutical equipment spectrum from clinical trials to large-scale production with a uniform operating concept and proven filling technology – and enables our partners to make strategically scalable investments."
Versynta FFP is suitable for filling both aseptic and highly potent products with short cycle times. Pressure and zone concepts can be adapted.
The portfolio will be completed next year with Versynta microBatch, a solution for even smaller batches. "Maximum product yield and fast batch changes are even more important in micro batch applications. The biggest challenge was to design the production cell isolator without glove ports," Klaus Ullherr said. The aim is a flexible and automated production cell with the smallest possible dimensions and a complete batch-to-batch batch changeover of less than two hours.
