Facilities

Flexible development and GMP manufacturing under one roof

Since founding StaniPharm in 2010, we have invested in a wide array of analytical and manufacturing equipment that allows us to develop solutions to complex design challenges and scale-up to GMP manufacturing to meet our client’s needs.

A hallmark of our state-of-the-art facility is its flexible design as there is no “one size fits all” when it comes to developing and manufacturing innovative health products.

Processing equipment

  • 8 supercritical fluid units from lab to manufacturing scale
  • Preparative supercritical fluid chromatography
  • Tangential Flow Filtration
  • MicrofluidicsTM microfluidizer
  • Chemical synthesis reactors
  • Liquid-liquid extraction, mixing, cristallisation, filtration, drying

 

Manufacturing is performed in ISO Class 7 clean rooms which include ISO Class 5 areas for critical operations.

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Analytical instruments

  • 3 HPLC (UV, DAD, ELSD, RI)
  • 2 GC (FID, headspace)
  • UV-Visible and FTIR spectrophotometers
  • in-vitro dissolution testing (USP 1 & 2)
  • Zetasizer Nano ZS dynamic light scattering/zeta potential
  • Mastersizer laser diffraction / wet dispersion
  • DSC


Other characterization techniques are available through our long-term partnership with expert CROs : XRPD, surface area, LC/MS, microbiology testing, storage for ICH stability studies…