At this year’s Achema in Frankfurt from 22 to 26 August, Syntegon will present new solutions for the filling of liquid pharmaceuticals, promoting the Versynta FFP (Flexible Filling Platform). With the new, modular FFP, the company offers an individually configurable machine for aseptic small batch filling, including high potent and BSL (Bio-Safety Level) pharmaceuticals. As the first filling platform of its kind worldwide, the Versynta FFP also features an integrated system for automated HEPA filter scans for RABS and isolators. Manufacturers can thus not only achieve significantly faster, reproducible results in real time, but also increase the reliability of their filter integrity tests.
Versynta portfolio – complete solutions for filling small and micro batches
Syntegon’s Versynta FFP Small Batch provides additional production flexibility. Especially in connection with highly specialized biotech drugs for small patient groups, easily adaptable filling machines can offer a decisive advantage. The Versynta FFP takes this trend into account: thanks to pre-developed and tested modules, the filling solution can be individually configured and output rates of up to 3,600 vials, syringes or cartridges per hour with simultaneous 100 percent in-process control can be achieved. The Versynta FFP also includes several pharmaceutical handling units: each consists of a four-axis robot that transfers containers from one station to the next without glass-to-glass contact, reducing product loss. Thanks to the small number of format parts, the Versynta FPP also supports quick and easy changeovers.
The Versynta microBatch completes the Versynta portfolio with a versatile solution for micro batch filling in isolators. At the booth, Syntegon will digitally showcase the highly flexible and fully automated production cell, which enables complete batch-to-batch changeovers in less than two hours. The gloveless isolator of the Versynta microBatch significantly reduces the risk of contamination and features integrated air management. “Our Versynta portfolio combines 40 years of isolator know-how and 70 years of expertise in pharmaceutical fill-finish processes,” explains Klaus Ullherr, senior product manager at Syntegon. “Our production isolators feature the fastest cycle times on the market. Pharmaceuticals manufacturers, development labs and biotech start-ups alike can benefit from this achievement. Our solutions support them in ensuring efficient processes at low output rates and with frequent batch changes,” Ullherr adds.
Worldwide first: automated HEPA filter integrity testing in isolators
Syntegon’s isolator expertise is at the heart of another innovation that the company will present for the first time at the Achema – an iRSF system for automated HEPA filter integrity testing in isolators on a Versynta FFP. Syntegon jointly developed the testing solution with InfraSolution, a specialist for technical plant equipment, software applications and robotics. It not only saves time compared to common manual methods, but also ensures safer processes and optimal data integrity.
During filter testing, a special robotic arm scans the entire geometry of the isolator surface. Thanks to integrated software, the device can detect any leaks via heat mapping in real time, visualize and document the measured values. “With our new system, we are fundamentally optimizing filter integrity tests,” says Dr Thomas Kosian, senior expert for barrier systems at Syntegon. “Especially when processing micro batches of highly potent and expensive drugs, it is crucial to ensure the highest product safety levels. Integrating the filterscan system into the Versynta FFP Small Batch as the world’s first pilot project was therefore an obvious choice – and delivers pharmaceuticals of the highest quality.”
Learn more about Syntegon’s technologies and services and meet the experts from August 22 to 26 at the Achema 2022 in Frankfurt at Stand C71 in Hall 3.1.