Article | April 27, 2013

A Guide To Homogenization In The Pharma, Biotech, And Cosmetic Industries

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, rotorstator 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

 

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