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Milling

DYNO®-MILL PHARMA

DYNO®-MILL PHARMA

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.


DYNO®-MILL PHARMA wet milling equipment:

  • is available in sizes ranging from initial R&D to full scale production
  • allows to process soft milling as well as high energy milling
  • enables particle size distributions from 10 micrometers down to and below 100 nanometers

Features

DYNO®-MILL PHARMA

For the various milling tasks, you need a supplier offering a broad range of products and experience. The combination of these abilities ensures reliable project support and on-time delivery.

Depending on the individual product selection, the DYNO®-MILL PHARMA equipment support offers:

  • WAB qualification concept (FDS, DQ, IQ and OQ)
  • Factory Acceptance Test (FAT)
  • Site Acceptance Test (SAT)
  • Semi-automatic or fully automatic control units
  • 21 CFR part 11 compliant WAB SCADA-System
  • Cleaning-in-Place (CIP)
  • Sterilization-in-Place (SIP)
  • Nanomilling
  • Execution in 316 L or ceramic materials
  • Suitability for temperature sensitive products
  • Suitability for low dust environments
  • Low energy consumption
  • Compact machine sizes
  • Low noise levels
  • Mobile skid units available
  • Fast production changes
  • and more …
     

Applications

DYNO®-MILL PHARMA

Pharmaceutical Industry

Downloads

DYNO®-MILL PHARMA