Linde gases has developed technology for improving control and efficiency of pharmaceutical freeze drying processes.

Linde’s proprietary VERISEQ® Nucleation controls formation of ice crystals using a sterile cryogenic ice fog resulting in enhanced lyophilisation (freeze drying) cycles and improved product quality.

Linde introduced the new technology in Frankfurt, Germany, last month at ACHEMA 2012, the World Exhibition Congress on Chemical Engineering, Environmental Protection and Biotechnology.

Art Shirley, head of Chemistry and Energy for Linde Gases, said, “VERISEQ® Nucleation will reinforce Linde’s profile in the pharmaceutical industry as a sophisticated solutions provider, and build awareness for our products as a family brand for Linde’s pharmaceutical solutions.”

Biologics like proteins, vaccines and other injectables must remain effective from manufacture to patient administration. These substances are expensive, fragile and can lose their efficacy during storage. Lyophilisation is a dehydration process for stabilising these valuable medical sub­stances that is conducted in highly controlled environments and in compliance with strict regulatory guidelines. The temperature at which a vial freezes (ice nucleation temperature) is critical in the process to optimise production times and improve the quality of the final product.

Prerona Chakravarty, Linde’s project manager for VERISEQ® Nucleation said, “Until now, there has been no commercially feasible way of achieving uniform ice nucleation, which could shorten operating cycles, improve yield and reduce overall uncertainty in scale-up.  Our technology provides end users with a new degree of control leading to more robust lyophilisation cycles.”

VERISEQ Nucleation uses a sterile freezing mist (ice fog) that rap­idly spreads throughout the lyophilising chamber and causes all vials to freeze at the same time and at the desired temperature. “Controlling the nucleation temperature produces the preferred ice structure within the product which reduces processing time and minimizes product damage,” Chakravarty said.

Linde has been collaborating with leading freeze drying equip­ment manufacturer IMA Life North America, to test and demonstrate this technology.

Joseph Brower, technology manager for IMA Life North America, said, “Test results demonstrate the feasibility of VERISEQ Nucleation for both small-scale development and large-scale aseptic manufacturing. Results also indicate that both reduced cycle times, and increased product homogeneity are possible. The advantage of VERISEQ Nucleation is that it can be retrofitted to existing freeze dryers as well as incorporated into new installations. Initial customer feedback from our demonstrations has been very positive.”