CUMULUS Cryogenic Lyophilization and VERISEQ Nucleation
Improved Freeze-Drying of Valuable Biologicals and Active Pharmaceutical Products (APIs)
Controlled Nucleation
The challenge for successful lyophilization lies in controlling the nucleation temperature (the temperature at which a biological vial freezes). This is the most effective way of producing a homogenous structure within the product.
Lack of control can adversely affect the product’s uniformity due to suboptimal freeze-drying cycles. With our proprietary VERISEQ® Nucleation technology, liquid nitrogen creates a sterile ice fog that is distributed inside the freeze dryer to simultaneously and uniformly nucleate all of the vials. The uniformity provided by our nucleation technology results in a wide range of benefits, including accelerated cycle times, enhanced process control, process repeatability, improved product quality, and shorter reconstitution times. This technology is applicable to laboratory, pilot and production-scale freeze dryers with the added bonus of eliminating the need for pressure rating.
Cryogenic Lyophilization
Traditional mechanical cooling systems can be replaced with cryogenic cooling solutions, targeting both the shelves and condenser coils. Based on our patented CUMULUS® design, our cryogenic lyophilization technology allows pharmaceutical producers to reach significantly lower operating temperatures than those previously possible with industry-standard silicone oil heat transfer fluids.
It also enables operators to ramp down temperatures at unprecedented rates. In addition to providing a reliable source of cooling, our solution eliminates the maintenance effort associated with compressors. And it integrates seamlessly into existing freeze dryers with its compact footprint.
A Strong Partnership
VERISEQ Nucleation and CUMULUS LF technologies were developed by Linde. Our partner IMA Life exclusively distributes both application technologies.