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Integrated Syringe Filling Line for Pharmaceuticals in Clinical Trials
April 28, 2008
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Bosch Packaging Technology expands its portfolio of filling lines for pre-sterilized syringes with the FXS 2050. Bosch has developed this new line for processing liquid pharmaceuticals during the clinical trials phase. The FXS 2050 has the same process parameters used in mass production, but with reduced packaging and process variables.

"When pharmaceutical manufacturers progress from clinical trials to mass production they must understand how products will react to large-scale filling operations", says Klaus Ullherr, Product Manager for syringes at Bosch Packaging Technology. "The FXS 2050 meets this demand in the pharmaceutical sector. Using reduced parameters designed for a smaller system, the FXS 2050 simulates the conditions of mass production. The system enables producers to determine feasible parameters and optimized validation processes in order to minimize potential risks when scaling up to mass production."

The FXS 2050 is a fully automated line. The reduction of manual operations and interventions minimizes contamination risks. The line includes an automated bag opener (ABO) as well as an automatic tub opening system (ATO) for the gentle and low-particle opening of tubs as well as an automated filling volume control. Separate, servo-driven rotary piston pumps ensure accurate filling volumes. Sampling, or removal of individual syringes for sampling purposes, is also automated.

Integration of the FXS 2050 into a Restricted Access Barrier System (RABS) enables operation under cleanroom class A conditions. The FXS 2050's compact design and small footprint ensure mobility, especially crucial in early clinical trials, and also minimize total operating costs.

About Bosch Packaging Technology

Bosch Packaging Technology, headquartered in Waiblingen (Germany), is one of the leading suppliers for holistic systems for packaging and process technology. In 14 countries worldwide the company develops, produces and distributes modules and systems for the pharmaceutical, confectionery, and cosmetics industries, as well as other food and non-food industries. Learn more at www.boschpackaging.com.


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