PAT Advances Freeze Dryer Control

Demand for aseptic packaging and preservation, as well as the rise in production of protein-based drugs, continues to boost global demand for lyophilization capacity. As a consequence, pharmaceutical manufacturers and their equipment suppliers are turning to an array of process analytical technologies (PAT) to help optimize their freeze-drying operations. "Genomic and designer drug development will continue to drive the market for vial/parenteral systems," says Chuck Dern, lead engineer with SP Industries (Warminster, Pa.). Meanwhile, in tray lyophilization, the need to preserve the form and functionality of therapeutics, including nanotech and bioprocessing products, is pushing growth, says Walt Pebley, director of business development for Oregon Freeze Dry (Albany, Ore.). Today, freeze-drying equipment is handling larger batches, and portions of loading and unloading have been automated, minimizing operator exposure and the potential for product contamination (Box). Until recently, though, monitoring the process generally meant inserting temperature probes into product vials, then using statistical methods to estimate average process parameters "an imperfect process that isn't well suited to freeze dryers with automated loading or unloading features.