There has been a noticeable shift in the pharmaceutical industry: more and more high-priced biotech drugs for small patient populations require highly flexible filling solutions that achieve precise product yields at low output.
Accordingly, Syntegon Technology has developed a new portfolio: the company now bundles systems for small and micro batch applications under the name Versynta. The new, modular small batch Versynta FFP is an individually configurable machine with an integratable isolator for filling aseptic and highly potent liquid active ingredients.
Integrated flexibility, reduced format parts and safe transport
Versynta FFP stands for Flexible Filling Platform, and it is designed to offer pharmaceutical manufacturers, R&D laboratories, and biotech startups a combination of standardization and high modularity with short delivery times.
The platform is based on pre-developed and tested modules that can be flexibly combined. Versynta FFP processes up to 3,600 containers/hr and comes with 100% in-process control.
Versynta FFP can be easily 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, only format parts need to be replaced, which have also been kept to a minimum. 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, allows for safe and gentle transport. It transfers the containers from one station to the next without glass-to-glass contact. The laminar flow-optimized design ensures that the air flow can reach the containers and flow around them without obstruction (“first air supply”).
First customer application of Versynta FFP
Primarily known for medium and high-performance lines, Syntegon’s complete portfolio covers the entire pharmaceutical equipment spectrum from clinical trials to large-scale production.
Customers receive a lean and complete solution for the entire filling process from a single source, including an integrated isolator and ventilation technology. Versynta FFP is suitable for filling both aseptic and highly potent products with short cycle times. Pressure and zone concepts can be flexibly adapted. International pharmaceutical company Ferring Pharmaceuticals is working on the first installation of Versynta FFP with Syntegon.
The Versynta portfolio is completed with Versynta microBatch, a system for even smaller batches, which will be launched next year and is already being tested with a customer. Targets include maximum product yield and fast batch changes. The company reports that a major challenge was to design the production cell isolator without glove ports. The result is a flexible and fully automated production cell with compact dimensions, and a complete batch-to-batch batch changeover of less than two hours.
Experience Versynta live
Customers and interested parties can experience the benefits of the new Versynta platform live on two occasions: on June 15 and 16 at Achema Pulse, and at Syntegon’s virtual event from June 22 to 24, 2021.