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Versynta microBatch
Cell and gene therapies enable the treatment of previously debilitating diseases. While their batch sizes are small, their production is cost and time intensive.
The gloveless Versynta microBatch working cell is the realization of robotic competence on the smallest scale. Following the trend towards even smaller batches, the highly flexible and fully automated setup allows the processing of aseptic and high-potency micro batches.
Fast batch-to-batch changeovers, minimized product loss and a fully integrated
machine and isolator are the keys to ensure quality and output.
Product safety means keeping human intervention to a minimum. This is especially true for high value medicines like biopharmaceuticals produced in very small batches. For utmost protection, the Versynta microBatch includes an integrated gloveless isolator. The fully robotic working cell meets the strictest quality requirements at the smallest scale.
The secure fill-finish of micro batches requires reduced operator intervention. Besides the integrated gloveless isolator, the Versynta microBatch relies on leading robotics technology to ensure reproducible processes with no manual interventions. Robots like the Syntegon Pharma Handling Unit cover key process steps such as filling and closing in a truly automated way.
The dimensions of the machine are small and can easily be integrated into existing production environments. The integrated air treatment system minimizes the need for interfaces to the building or technical ceiling installations. The new development sets new standards, particulary in terms of automation. The gloveless isolator with integrated air handling significantly reduces the risk of contamination since it eliminates manual intervention.
While batch sizes tend to decrease, the variety of packaging styles remains at an all-time high. Syringes, vials, and cartridges are the most commonly used RTU containers for liquid pharmaceuticals and can all be processed on the Versynta microBatch. The system has been designed to fill and close a wide variety of glass or plastic containers. We focus on loss-free filling to enhance the quality of our customers’ micro batch filling operations.
Fast batch-to-batch changeovers, minimized product loss, a fully automated filling and 100 percent in-process control ensure continuously high quality and output.
The microBatch set-up meets the highest sterility requirements as specified by Annex 1.
Syringes, vials and cartridges can be processed at our Versynta microBatch. Also rubber stoppers, aluminum seals and press-fit caps can be handled.
Glove ports are used to position the bag and remove waste. So the bag can be opened without any contact with the tub. This system is easily integrated into existing production line concepts.
The waste bag is placed and connected under the machine using a rapid transfer port and a heating frame is integrated into the system to minimize particle generation.
Containers, while being weighed and filled, remain in nest. Additionally, the output can be increased with statistical IPC.
Disposable racks are introduced through a rapid transfer port. Furthermore, the system offers fully automated settle plate handling.
An innovative sorting system eliminates the need for bowls. This system utilizes a camera system for picking of stoppers and caps.
The system offers a fully integrated air handling. This is achieved through a room-in/room-out concept, which simplifies room integration.
"Our Versynta portfolio follows a clear market trend: smaller batches for new innovative medicine. Versynta microBatch meets the highest sterility requirements as specified by Annex 1 and can process nearly all RTU containers.”
Klaus Ullherr, Senior Product Manager at Syntegon
“With Versynta, our system portfolio for small batches meets the innovative Versynta FFP and the Versynta microBatch development project. The name Versynta is based on the English term 'versatile'. ‘Synt’ stands for Syntegon and is rounded off with a pleasant sounding ‘a’.”
Daniela Götz – Marketing Manager at Syntegon
Experience state-of-the-art technology in the fully automated processing of syringes, vials and cartridges and learn how our microBatch solution can revolutionise your production processes.
Interest in seeing the Versynta microBatch in action?
Performance meets precision in Syntegon’s cartridge filling and capping portfolio. Our solutions for all output ranges help you process cartridges at optimum conditions.
Syringes are the go-to packaging for highly potent parenteral drugs. We offer you a large variety of fully automated syringe filling lines that cater to maximum product safety and process flexibility.
Pharmaceutical manufacturers have been trusting Syntegon for more than 60 years to process their vials reliably, safely, and efficiently. Our customers process some of the most valuable and urgently needed pharmaceutical liquids, for example the new Covid-19 vaccines, oncology preparations or other biopharmaceutical drugs on our lines.
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Small Batch expertise with over 60 references, almost 15 years in the small batch field
Award winning design: Equipment doesn’t need to be marketed to be in the limelight: in October 2021, Syntegon received the Parenteral Drug Association’s Innovation Award for its Versynta microBatch development project. The award honours the novel approach, which is expected to set a new industry standard for small-scale filling processes. Read the press release to find a more.
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