Lining Up New Vial Capacity
Baxter's new vial line, Line 8, can improve yield and reduce the risk of contamination.
Baxter’s Bloomington, IN, facility expansion includes a new vial line, Line 8. The line can help Baxter “improve yield and reduce the risk of contamination, as well as provide the distinctive technologies needed to produce many of the new biologics and special small-molecule formulations,” the company reports. The custom-designed line helped Baxter secure the 2006 Pharmaceutical Facility of the Year Award by the International Society of Pharmaceutical Engineers.
“Line 8 complements our current vial capabilities by adding unique, new capabilities and batch sizes for biologics,” say Bob Lutes, director of engineering. Lutes’ team has been leading line installation and validation. Liquid-filling capabilities will be available for commercial product in the third quarter of 2007, and lyophilization capabilities are scheduled for availability in 2008. Line 8 is the first Bloomington vial line with 100%, in-line fill-volume analysis. Such fill-volume monitoring may enable yield improvements by eliminating destructive testing methods. The line also follows FDA’s recommendations in “Guidance for Industry Sterile Drug Products Produced by Aseptic Processing” for the use of automated quality assurance detection systems. For lyophilized vials, Line 8 employs automated robotic loading and unloading of all lyophilization chambers. For all vials, Line 8 features on-line vision inspection to measure stopper seating prior to crimping. Such 100% inspection can detect improperly seated stoppers that could increase the risk of contamination between the vial and seal in transit to the capping room. Line 8 also provides complete cold-chain management by maintaining filling and loading systems and processes at controlled cold temperatures.
Finally, Line 8 includes insoluble formulation technology that can prepare commercial batches using Baxter’s NanoEdge dispersion technology.