Achema 2022: Syntegon showcases innovative solutions for processing liquid pharmaceuticals

Die neue, modulare Small Batch-Lösung Versynta FFP ist eine individuell konfigurierbare Maschine mitsamt integrierbarem Isolator für die Abfüllung aseptischer und hochpotenter flüssiger Wirkstoffe. / The new modular small batch solution Versynta FFP is an individually configurable machine offering full isolator integration for filling aseptic and highly potent liquid active ingredients.

Die modulare und innovative Plattform für RTU- und Bulk-Behältnisse umfasst vorentwickelte und vorgetestete Module, die eine Ausbringung von bis zu 3.600 Behältnissen pro Stunde ermöglichen. Zudem bietet Versynta FFP eine 100%-ige In-Prozess-Kontrolle. / The modular and innovative platform for RTU and bulk containers includes pre-developed and pre-tested modules that enable outputs of up to 3,600 containers per hour. In addition, the Versynta FFP offers 100 percent in-process control.

Die Versynta microBatch Arbeitszelle ohne Handschuheingriffe steht für höchste Robotik-Kompetenz auf kleinstem Raum. Die hochflexible und vollautomatische Plattform unterstützt bei der Verarbeitung von aseptischen und hochpotenten Kleinstchargen. / The Versynta microBatch production cell without glove ports delivers the highest level of robotics expertise with the smallest possible footprint. The highly flexible and fully automated platform supports the processing of aseptic and highly potent micro batches.

Die Integration des Filterscan-Systems in die Versynta FFP Small Batch gewährleistet höchste Produktsicherheit und größere Datenintegrität. / The integration of the Filterscan system with the Versynta FFP Small Batch ensures optimal product safety and data integrity.

Syntegon bietet ein umfassendes Portfolio an digitalen Lösungen. Durch die Überwachung von Maschinenzuständen, Prozessschritten oder Anlagenstörungen eröffnen sich neue Möglichkeiten für individuelle Unterstützung. / Syntegon offers a comprehensive portfolio of digital solutions. By monitoring machine conditions, process steps or plant malfunctions, they provide the basis for individualized support.

– Versynta FFP Small Batch: flexible platform for high product safety during small batch filling
– Worldwide first: new robotic and automatic filter scanning system for isolators
– Inspection solutions for liquid pharmaceuticals to ensure quality throughout the entire production process

At this year’s Achema in Frankfurt, 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.”

Comprehensive pharmaceuticals expertise and service portfolio

In addition to the systems on display, Syntegon’s portfolio includes further solutions for producing and ensuring the quality of liquid pharmaceuticals. Its products range from stand-alone machines to complete solutions, both for laboratory-size and high-performance applications, as well as freeze dryers including a new and patented loading and unloading system and flexible fill-finish machines. Its platforms include inline inspection systems for monitoring individual process steps during filling, and solutions for visual inspection using artificial intelligence. In addition, Syntegon offers bioprocessing systems for active ingredient production, and assembly machines for autoinjectors and pens.

A comprehensive consulting and service offering spanning the entire machine lifecycle rounds out the portfolio. Whether spare parts service or remote maintenance, modernization or preventive maintenance, Syntegon covers a wide range of new and customized services, including new digital solutions for holistic machine data collection, processing and analysis.