Product/Service

Pharmaceutical Homogenizer Applications

Source: GEA Niro Soavi

Homogenization (known in the pharmaceutical industry as micronization) is the process of reducing the particle sizes of pharmaceutical products, under very high pressures, sheer, turbulence, acceleration and impact, to make them more stable and clinically effective. 

Homogenization (known in the pharmaceutical industry as micronization) is the process of reducing the particle sizes of pharmaceutical products, under very high pressures, sheer, turbulence, acceleration and impact, to make them more stable and clinically effective. The bioavailability of the product increases and the tolerance of some otherwise borderline drugs can improve.

The emulsion, suspension or solution is pumped into the high-pressure homogenizer after which it is forced through a special homogenization valve at extremely high pressures (up to 1,500 bar / 21,750 PSI). The particles enter the homogenizer with 500 µm maximum sizes, after the treatment the large particles are dispersed and reduced, the particle size typically range from 0.4 to 1 micron depending on the specific application.

High-pressure homogenization in the pharmaceutical industry has proven its ability to make more stable product, with better active ingredient dispersion, than has been achieved with conventional stirrers, rotor-stator devices or colloid mills. It achieves this by reducing the particle size and uniformity under conditions of extreme pressure and stress. The result is a more clinically effective product with greater stability and shelf life.

A typical Niro Soavi homogenizer for pharmaceutical applications features the following

  • Very high pressure (VHP) design
  • High wear resistant parts and homogenizing valves
  • cGMP Pharma design
  • All wetted parts are electro-polished, final surface roughness Ra<0,5µm
  • FDA approved gaskets
  • Certification Manual for Pharma validation cGMP
  • Special aseptic execution with closed loop aseptic circuit
  • Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) -able
  • Sanitary pocketless design is free draining
  • Designed to be fully compliant with 21 CFR (Code of Federal Regulations) PART 11

Typical Cosmetic, Biotech and Pharma Applications

  • Antibiotics
  • Ointments
  • Beauty creams
  • Perfumes
  • Cosmetics
  • Proteins
  • Liposome suspensions
  • Soaps (liquid/bar)
  • Lotion
  • Syrups
  • Enzymes
  • Bacteria
  • API (Active Pharmaceutical Ingredients)
  • Medicinal syrups
  • Toothpaste
  • Moisture creams
  • Vitamins
  • Nail varnishes
  • Shampoo
  • Cream
  • New-age health products
  • Viruses