The new unit will comprise three manufacturing clean rooms, and microbiological and chemical laboratories.
Vetter said that the facility features a fully automated production line that automates processes including labeling, plunger rod insertion, packing in boxes, and the transport between stations. The line allows packaging twice the number of injection systems in half the time required before.
According to Thomas Otto, managing director of Vetter, the 24,000sq ft facility, which is an expansion of Vetter Development Service, will commence operations by the beginning of the fourth quarter 2010. The company said that one clean room would consist a filling line for semi-automated, small-scale filling of vials, syringes, and cartridges.
Filling operations in a second clean room will focus on pre-sterilizied syringes. A third clean room will feature the MHI 2020 automated vial filler from Bosch Packaging Technology. The unit can be used for filling liquid vials from 10 to 10,000 pieces per batch and for lyophilized vials from 500 to 5,000 pieces per batch.
Vetter, to assemble and pack prefilled injection systems in the final stage, has expanded its service offering in parenteral packaging with launch of a Vetter Secondary Packaging facility in Ravensburg, in 2009.
Mr Otto said: “We will initially focus on early-stage products from preclinical through phase IIb, after which we will scale up and transfer products to our facilities for phase III filling and market production. To help ensure a seamless transition to commercial manufacture, we’re replicating commercial processes at our early-stage (Skokie) site.
“It’s a compact machine with minimum tubing lengths, which increases API yield. And it includes a check-weight system. That’s important, because if the amount of drug in a vial is inaccurate, that may affect the outcome of a clinical study, especially in small, early-stage trials.”