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Sterile ice fog improves control of freeze-drying

By Scott Jenkins |

Linde Gases (Murray Hill, N.J.; www.linde-gases.com) has developed a novel cryogenic technology that promotes uniformity in the formation of ice crystals during freeze-drying (lyophilization) processes for proteins, vaccines and other injectable pharmaceutical products. Lyophilization involves freezing a solution of the product, then reducing the surrounding pressure to allow the water to sublimate. Because of the high purity of the water and clean production environments used in pharmaceutical products, there is a lack of nucleation points for water to begin freezing, explains Prerona Chakravarty, Manager of Linde’s project, known as VeriSeq Nucleation. The solutions become supercooled, which makes controlling the formation of ice crystals difficult, she adds. This lack of control lengthens operating cycles and reduces product yields. The Linde technology uses a proprietary mixing technique to blend liquid nitrogen with ultrapure water to create a mist of fine, sterile ice crystals. The “ice fog rapidly spreads throughout the lyophilizing chamber and causes all vials to freeze at the same time and at the desired temperature. Controlling the temperature at which a vial freezes — the ice nucleation temperature —…
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