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The official market launch of the new Versynta microBatch from Syntegon at CPHI Barcelona was a crowd puller. The gloveless production cell surprised visitors with both its numerous technological innovations and with the first sale to development partner Vetter, a CDMO.
An award-winning cooperation
“There was already a lively exchange between the experts on both sides during the development phase,” says Vetter Managing Director Thomas Otto.
The development partnership was honored with the PDA Drug Delivery Award in the category "Partnership Innovation" in 2021, followed by the German Packaging Award in 2022.
“Versynta microBatch enables us to achieve the desired flexibility, regulatory compliance, and high level of automation that we, as one of the leading service providers the fill and finish sector, want to offer our customers,” Otto says.
Maximum product yields
“With the new Versynta microBatch, we offer biotech and pharmaceutical companies an ideal solution for new, highly effective drugs for small patient groups. It ensures maximum product yields even with frequent batch changeovers,” says Klaus Ullherr, Senior Project Manager at Syntegon.
The fully automated, gloveless production cell fills between 120 and 500 syringes, cartridges, and vials made of glass or plastic per hour with virtually no product loss.
Prepared for Annex 1
The 100% in-process control provides high quality, while five integrated inline inspection systems ensure continuous process monitoring and particular safety by inspecting tubs, stoppers, and caps. Requirements of the new Annex 1 also were taken into account during development. For example, the gloveless isolator with integrated air management significantly reduces the risk of contamination. Optional network cameras facilitate continuous remote production monitoring in the isolator.
