12.18.23
Syntegon announced the first sale of its new Versynta microBatch to development partner Vetter. The Annex 1-compliant production cell with gloveless isolator and integrated air treatment is designed to offer new technological advances in aseptic filling. Syntegon launched the new Versynta microBatch at CPHI Barcelona this past October.
According to the company, the 100% in-process control provides high quality, while five integrated inline inspection systems ensure continuous process monitoring and safety by inspecting tubs, stoppers, and caps. Requirements of the new Annex 1 were considered during development. For example, the gloveless isolator with integrated air management is designed to significantly reduce the risk of contamination. Also, optional network cameras facilitate continuous remote production monitoring in the isolator.
“There was already a lively exchange between the experts on both sides during the development phase,” said 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.
“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,” said 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.
According to the company, the 100% in-process control provides high quality, while five integrated inline inspection systems ensure continuous process monitoring and safety by inspecting tubs, stoppers, and caps. Requirements of the new Annex 1 were considered during development. For example, the gloveless isolator with integrated air management is designed to significantly reduce the risk of contamination. Also, optional network cameras facilitate continuous remote production monitoring in the isolator.
“There was already a lively exchange between the experts on both sides during the development phase,” said 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.
“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,” said 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.