Cryogenic Processing

Cryogenic processing is a specialized service designed to facilitate the particle size reduction of materials that are otherwise difficult to process at ambient temperatures due to their physico-chemical characteristics. This technology is particularly essential for plastic materials, substances with a high level of residual solvents, and compounds with low melting points. High-energy mechanical milling and micronization generate significant heat through friction and impact, which can lead to chemical degradation, melting, or the unwanted formation of crusts and adhesion on equipment walls.

Using liquid nitrogen to cool-down the service gas via an heat exchanger, we achieve cryogenic conditions that shift the material's state from ductile to brittle. This embrittlement allows for efficient comminution through impact breakage mechanisms that would be impossible at room temperature. The intense cooling effectively manages the thermodynamics of the milling process (i.e. especially on mechanical mills), where the accumulation of mechanical energy would otherwise be lost to heat generation. Instead, the energy is directed toward the creation of new surfaces and material relaxation through fracture.

Cryogenic processing is vital for preserving the solid-state integrity of thermolabile APIs. By operating at low temperatures, we prevent polymorphic transitions and minimize the risk of unwanted amorphization induced by thermal stress. This service is often integrated into our containment and isolator systems, providing a safe and controlled environment for the processing of highly potent or sensitive pharmaceutical ingredients. The result is a high-purity micronized product with a consistent PSD, achieved without compromising the biopharmaceutical performance or chemical stability of the drug substance.