Particle Size Reduction of Active Pharmaceutical Ingredients (API ). The wet milling technology of WAB allows for effectively reducing the particle size of API and excipients. With the DYNO®-MILL PHARMA equipment, coarse particles are milled to establish the required particle size distribution. The DYNO®-MILL PHARMA equipment line is capable of mechanical Micronization and Nanosization at current Good Manufacturing Practice (cGMP) level protocols. Realised through semi-automatic or fully automatic control units, and the 21 CFR part 11 compliant WAB SCADA-System. In addition, selected DYNO®-MILL PHARMA units are available with Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) functionality. WAB supports its customers with great attention to detail from the initial definition of the User Requirement Specification (URS) throughout the IQ/OQ.
FUNCTIONALITY
The Pharmaceutical Manufacturer first prepares a pumpable suspension of the solid API in a liquid medium. This raw suspension usually has a very wide particle size distribution and contains a high percentage of coarse particles. The coarse particles are mainly formed by aggregated and agglomerated API material.
The main task of the DYNO®-MILL PHARMA equipment is to disperse the aggregates and agglomerates to the desired particle size distribution.
With the many stages and requirements in the API development process, a broad range of solutions is a helpful support.
WAB has decades of experience in the Pharmaceutical Industry and a proven spectrum of equipment to supports its global customer base.