Vetter's New Commercial Line Validated for cGMP Filling

Published on: April 12, 2013

Prefilled-syringe line features automation and novel disinfection techniques.

A new filling line at Vetter's Ravensburg Vetter South facility is fully validated and ready for cGMP filling after successful media-fill completion, with a customer project underway, the company announced in a press release. The line's capacity ranges from mid- to large-volume batch sizes, with a maximum filling speed of 800 presterilized syringes per minute. The line currently fills 1-mL, standard-format syringes, and additional formats will be added in the future.

The line was designed to exceed cGMP requirements. It uses Restricted Access Barrier Systems (RABS) and fully automated transfer of sterile, packed tubs throughout the filling process to minimize human contact. Novel disinfection techniques include a spray disinfection tunnel for bagged tubs that was codeveloped by Vetter and the equipment manufacturer.

The line also includes an end-to-end track-and-trace system that features automated disposal of rejects and sample removal following the filling process. Fully automated, in-line control of syringe closures uses a three-dimensional scanner prior to filling to minimize API loss and reduce risk of contamination. An in-line, automatic weighing system monitors filling quantities.