The wet milling technology of WAB allows for effectively reducing the particle size of active pharmaceutical ingredients (API) and excipients.
The wet milling technology of WAB allows for effectively reducing the particle size of active pharmaceutical ingredients (API) and excipients.
DYNO®-MILL PHARMA mills coarse particles to establish the required particle size distribution. The equipment line is capable of mechanical micronisation and nanosisation at current good manufacturing practice (cGMP) level protocols.
Realised through semi-automatic or fully automatic control units, WAB SCADA-System meets US Food and Drug Administration (FDA) 21 code of federal regulations (CFR) part 11 requirements. In addition, selected DYNO®-MILL PHARMA units are available with clean-in-place (CIP) and sterilisation-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 installation qualification (IQ) / operational qualification (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, which 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.
Key features of the DYNO®-MILL PHARMA wet milling equipment:
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