API Sterilization with Curia

Curia develops aseptic processes for active pharmaceutical ingredients (APIs) when terminal sterilization would compromise molecular stability or the impurity profile. Its approach combines sterile filtration of a dissolved API with controlled crystallization, isolation and packaging. The fact sheet explains how sterility assurance and the API’s physical properties are addressed across this workflow.

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The aseptic API manufacturing workflow

• Dissolution and sterile filtration. Filter selection considers the API, solvent and processing conditions. The resource describes a double 0.22 µm filtration system and post-filtration integrity testing.
• Crystallization and isolation. Crystallization conditions are used to control crystal form and particle size. Subsequent solid-liquid separation and drying remove solvent while managing sensitivity to temperature and moisture.
• Physical treatment and packaging. Milling or micronization can adjust particle size when needed. Closed systems and isolators support contamination control, with packaging adapted to the customer’s requirements.

Read the full fact sheet for the four-stage process, scale ranges, containment scope and in-house testing capabilities. It provides a useful basis for discussing a sterile API process and the physical attributes needed for downstream formulation.

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