SUPERCRITICAL FLUIDS GMP UNIT

Development and Production Workshops

Development workshop

  • High pressure pumps : 5 Kg/h and 50 Kg /h
  • Reactors : 2 and 5 Liters
  • Cyclonic separators
  • Specific High Potent Drug Area

 

 

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Production workshop

(for clinical cGMP batches and commercial cGMP batches)

  • High pressure pumps : 20 Kg /h to 500 Kg /h
  • Reactors : 10 and 50 Liters
  • Cyclonic separators : 10 and 20 Liters
  • Mixer Dryer under vacuum

 

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Highlights

  • 2004: creation of Supercritical Fluids unit
  • 2005: recognized as a Pharmaceutical establishment by French Health Authorities
  • From 2004 to 2006: Development of patented processes for innovative pre-formulation: Formulcoat®, Formuldisp®, Formulplex®
  • 2008: CPhI Silver Innovation Award for the Formulplex technology  
  • 2009: Pierre Potier Prize Innovation in Chemistry in favour of Sustainable Development
  • 2012: Adventrx and PFM Supercritical Fluids announce manufacturing agreement for ANX 188 Drug Substance
  • 2014: Beginning of collaboration for cleaning of Medical Device for external partners

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High Standards of Quality

  • cGMP UNIT
  • Pharmaceutical establishment ICHQ7A, EMA certified.
  • Clean room ISO 7
  • Specific air / CO2 / waste treatment Personnel highly trained

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