Some APIs are thermosensitive, brittle at low temperatures, or prone to degradation during standard milling. For these cases, Munit offers cryogenic milling services under nitrogen atmosphere, maintaining product integrity throughout the micronization process.
What Is Cryogenic Milling?
Cryogenic milling involves cooling the product using liquid nitrogen or other inert gases during micronization. This reduces thermal stress, improves milling efficiency, and prevents melting, sticking, or decomposition of sensitive APIs.
Munit’s Cryogenic Jet Milling System
Our proprietary spiral jet mills are configured for cryogenic operation, with full integration inside isolator systems or cleanrooms. Process parameters such as temperature, pressure, and flow rates are monitored in real time for GMP compliance.
Benefits for Pharmaceutical Applications
Cryogenic milling is especially beneficial for APIs with low melting points, polymorphism risk, or high potency requirements. It enables finer control over particle size and reduces agglomeration or static charge during processing.
Documentation and Quality Assurance
Each cryogenic process includes validated cleaning, batch record documentation, and full analytical support. All services comply with EU GMP and ISO 9001 standards, ensuring traceability and repeatability.
Protect thermosensitive APIs with cryogenic milling.
Talk to Munit about cold-process micronization.