Milling

Regis is a custom small molecule API manufacturer with an excellent quality record that offers many complementary support services including analytical development, solid state chemistry, and impurity identification, characterization, fate & purge studies, particle size reduction and wet (slurry) milling services.

Regis Technologies Scientist Evaluating Analytical Data In Expediting CGMP Scale Up Discovery To Market

Equipment:

  • Quadro Ytron HV0 Wet Mill & Emulsifier (includes Hastelloy C “wetted parts”)
  • Malvern 3000 Particle Size Analyzer

Why Wet Milling?

  • Wet Milling can readily achieve particle sizes similar to jet milling (10-20 microns)
  • Advantages of Wet Milling vs. Jet Milling
    • Does not require special containment for SafeBridge 3+ compound handling (materials are slurried in a liquid)
    • Ideal choice for sensitive materials, as liquid dissipates heat from the mill
      • Little chance for form change during micronization, which can happen with jet milling
    • Little or no yield loss (material loss from Jet Milling can typically be 10-20%)
    • No need for separate lab and production units
      • Same unit handles lab and production runs
      • Straightforward correlation between lab and production particle sizes
    • Wet Milling is a minor operation that is added to the final processing step where the slurry (API/solvent) is run through the wet mill followed by the final filtration and drying. The operation is built into the master batch record, has little/no yield loss, and no separate containment is required outside of normal operations.
Regis Technologies Scientist Evaluating Analytical Data In Expediting CGMP Scale Up Discovery To Market

Equipment:

    Quadro Ytron HV0 Wet Mill & Emulsifier (includes Hastelloy C “wetted parts”)

  • Malvern 3000 Particle Size Analyzer

Image Of Regis Technologies Chemist Working On CGMP Development In Cryogenic Reactor

Why Wet Milling?

  • Wet Milling can readily achieve particle sizes similar to jet milling (10-20 microns)
  • Advantages of Wet Milling vs. Jet Milling
    • Does not require special containment for SafeBridge 3+ compound handling (materials are slurried in a liquid)
    • Ideal choice for sensitive materials, as liquid dissipates heat from the mill
      • Little chance for form change during micronization, which can happen with jet milling
    • Little or no yield loss (material loss from Jet Milling can typically be 10-20%)
    • No need for separate lab and production units
      • Same unit handles lab and production runs
      • Straightforward correlation between lab and production particle sizes
    • Wet Milling is a minor operation that is added to the final processing step where the slurry (API/solvent) is run through the wet mill followed by the final filtration and drying. The operation is built into the master batch record, has little/no yield loss, and no separate containment is required outside of normal operations.

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