Linde Gases unveils new cryogenic technology for lyophilisation

The new cryogenic technology leverages sterile cryogenic ice fog to control the formation of ice crystals during the lyophilisation or freeze drying process and enhance lyophilisation cycles and improve product quality.

Linde Gases Division chemistry and energy head Art Shirley said until now, there has been no commercially feasible way of achieving uniform ice nucleation, which has resulted in prolonged operating cycles, reduced yield and overall uncertainty in scale-up.

"Linde’s VERISEQ Nucleation technology will provide end users a new degree of control leading to more robust lyophilisation cycles," Shirley added.

A sterile freezing mist, a type of ice fog, spreads rapidly throughout the lyophilising chamber and causes all vials to freeze at the same time and at the desired temperature, which produces the preferred ice structure within the product thereby reducing the processing time and minimising the product damage.

IMA Life North America technology manager Joseph Brower 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," Brower added.

"The advantage of VERISEQ Nucleation is that it can be retrofitted to existing freeze dryers as well as incorporated into new installations, and initial customer feedback from demonstrations has been very positive."

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