Introduction to SIP case application of sterile active pharmaceutical ingredient mill

The crushing of sterile active pharmaceutical ingredients (APIs) must simultaneously meet the dual objectives of particle size control and sterility assurance. Specific requirements include: first, tightness, where the entire equipment must be designed to be sealed, isolating the material flow process from the outside environment, reducing personnel contact and environmental contaminant intrusion, and meeting the control requirements of the new version of GMP for a dynamic Class A environment; second, dead space-free design, where the crushing chamber, screen mesh, connecting parts, and other parts in contact with the material must be smoothly polished to avoid pits and gaps that could lead to material residue and microbial growth, commonly using 316L stainless steel to ensure material compatibility; third, precise particle size control, where particle size adjustment ranging from 8μm to 100 mesh is achieved according to formulation requirements, while ensuring uniform particle size distribution to avoid crystal transformation caused by excessive crushing; fourth, cleanability and sterilizability, where the equipment must support integrated operations of clean-in-place (CIP) and sterilize-in-place (SIP), with clamp-type design for component connections to facilitate rapid disassembly, assembly, and maintenance.