New Bosch vial filling system promises clinical trial efficiency
system, a scaled-down version of full-sized filling units that is
geared specifically to use in the early stages of clinical trials.
While the FLT1020 is not the first clinical-scale vial filler to be offered by Bosch, it is the first to be designed along the same lines as a full-sized machine, with the same basic features, noted Tony Miller, advertising and marketing co-ordinator for the Bosch Packaging Technology subsidiary Bosch Pharmaceutical USA. While the US company is flagging up the availability of the FLT1020 system, the new unit is being launched worldwide on a platform of improving clinical trial efficiency. "Pharmaceutical firms moving from clinical trials to the production phase need to be able to predict how a drug will handle on the filling line," pointed out Jeff Jackson, product manager for Bosch Packaging. With the scaled-down FLT1020, manufacturers can replicate the conditions of pharmaceutical mass production, he said, adding: "A smaller system enables firms to anticipate potential variables, streamline validation procedures, and thus minimise the risks associated with scale-up." The FLT1020 offers a flexible vial processing range (diameter 16mm-52mm, height 25mm-95mm, neck finish 13mm-20mm) and variable tray-size options (8-15' width, 12-18' length). The maximum throughput is 30 vials per minute (VPM). The new unit's linear table-top design "allows for a smaller footprint and mobility during the beginning clinical phase of drug development", Bosch noted, adding that a compact, mobile system "significantly reduces total cost of ownership". The FLT1020 is also the only small-scale vial-filling system to include integrated capping and a linear 'v-cleat' transport, eliminating the need for vial size parts and improving machine access while reducing overall width, Bosch pointed out. The system is compatible with a variety of dosing systems used on high-speed production filling lines, including rolling diaphragm pumps, piston pumps, peristaltic pumps and Millipore's Acerta liquid dispensing system. Optional accessories include compatibility with feeding systems, isolators, and tray-on and tray-off stations. Another feature is a touch-screen control panel with intuitive programming and controls. "In the dynamic, ever-changing pharmaceutical market, the uncertain first stages of the clinical trial phase are critical to the ultimate success of a drug," commented Paul Tinucci, principle applications engineer for Bosch Packaging. "This system provides a new level of increased flexibility that enables manufacturers to lessen the risk associated with the early stages of drug development." While the FLT1020 is not strictly confined to early-stage clinical trials, the 30 VPM throughput would be a limiting factor with higher-volume production, Miller observed. Pricing of the new unit would depend on individual set-ups, he said.