Orléans Tech R&D Center

Center Activities

 

  • Integrated into Famar Orleans, Famar’s center of excellence for Liquids and Semi solids on one hand, effervescent and powder in sachets on the other hand.

  • Formulation and process development for Rx, OTC and cosmetics

         - semi-solids /liquids dosage forms

         - and solids (sachets, effervescents)

  • Analytical methods development and validation

  • Pilot scale activities

  • GMP clinical batch manufacturing and labeling (except randomization)

         - Batch release analysis and shipments to CRO’s

         - In Use stability testing and ICH stability studies

         - Tech transfer to and from selected manufacturing site (Customer/FAMAR)

         - Manufacturing process validation at industrial scale

  • Packaging compatibility testing

  • Trouble shooting – risk analysis (manufacturing and QC support)

 

Liquids and semi-solids (emulsion, ointment, toothpaste)

  • 1 formulation Lab (non GMP)
  • 1 GMP pilot line for liquids in manufacturing

  • 1 GMP flexible pilot area (250 m2)

  • Mixing capacities

  • Mixers Turbotests, Ultraturax, Silverson

  • Equipments Rayneri 5l, 60l and 120l, Becomix 30l

         - 100l jacked mixer

         - Liquid manufacturing line 1000l (premix: 400l)

         - Melting Rayneri 50l, colloidal mills

  • Filling capacities

         - Sprays, bottles (PET, glass), alu or aluminoplastic tubes

  • IPC controls

  • Particle size distribution (microscopy, laser)

  • Rheology behavior (Brookfield®, Carimed®), pH, etc.

Solids (sachets, moisture sensitive tablets)

  •  GMP pilot area
  • Mixing capacities: CMA Blenders : 15l to 600l

  • Compaction Alexanderwerk (20-30 kg/hour)

  • Sachet filling machine Mediseal LA160 (double line /25 sachets/min.)

  • Tabletting machine Fette P1000 + alu/alu wrapping

  • IPC controls: tablet mass, hardness, thickness, etc. 

Analytical development

   

Physicochemical capabilities

  • Liquid chromatography HPLC

           - Gradient/isocratic

           - Several detection

                UV/Visible

                Fluorimeter

                Refractometer

                Diode Array

                Ionic chromatography

                Conductimetry

  • GC: FID, head space

  • IR: Near IR - ATR

  • Polarimeter, UV, Dr Lange

         - Atomic absorption (AAS)

         - TLC

         - Potentiometry

         - Particle size distribution

         - Microscopy Malvern® with automatic counting system

         - Laser Malvern ®

         - Viscosity

         - Brookfield ®

         - Carimed ® (rheology)

  • ICH stability conditions

            25°C/60%RH, 30°C/65%RH, 40°C/75%RH

            25°C/40%RH, 30°C/35%RH, 40°C/25%RH

            30°C/75%RH (climatic zone: IVb )

            5°C, -15°C

  • Photostability testing: suntest

  • Accelerated degradation: 50°C to 80°C

  • Cycling studies

     

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