Dalle sostanze chimiche ai prodotti farmaceutici

From chemicals to pharmaceuticals

Zach System

Manufacturing

Avrillé

Zach Avrillé site

Zach Avrillé site has a long tradition in process development & API/ pharmaceutical intermediates manufacturing.

  • 170 employees (18 in R & D)
  • Long-term experience with the main regulatory authorities (FDA, local authorities, PMDA, K-FDA)
  • Complete regulatory support (DMF, IMPD)
  • 215MT of APIs and GMP intermediates manufactured each year
  • Approximately 6000 samples analyzed each year in CQ
  • 70% of the activity is concentrated in the Custom Manufacturing sector
  • 5-10 new projects / products developed each year
  • Manipulation of HPAPI with OEL> 1 μg / m3 (OEB 4) on an industrial scale
  • Continuous investments (new laboratory confined for the handling of HPAPI, filter dryer in Hastelloy, Pin Mill)
  • Project Management Approach

Our numbers

Avrillé/ Francia
Avrillé
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Spray Dryer

Spray Dryer
API

Our finishing equipments are located in clean rooms (ISO8) fed with purified / low pyrogen water

Isolation & Drying

  • Mixing and Reaction Calvet Calorimeter C 80
  • Two Mettler RC-1 Reaction Calorimeters, one with cryogenic unit
  • Integrated Thermal Analysis (TA) system consisting of (a) Modulated DSC (Tzero technology), Q100-MFC, and (b) Dynamic High-Resolution TGA
  • React-I 4000 system for the online measurement of reaction kinetics
  • Lasentec probe for crystallization optimization and control
  • TGA controlled IR-NIR-RAMAN spectrometry platform 

Particle size reduction

  • Pin mill under nitrogen
  • Compliance with all relevant cGMP and ISO standards, allowing the preparation of samples for pre-clinical and early-phase clinical studies
  • Hammer mill under nitrogen
  • Jet mill (200 & 300)

Class of products

  • Classical APIs made in multipurpose equipments 
  • High potent APIs having an OEL> 1 µg/m3 (OEB 4) including corticosteroids at industrial scale
  • High Purity Low Endotoxins EXCIPIENTS
     

The assurance of cutting-edge plants

Zach System's customer commitment offers the assurance of cost-effective solutions able to provide full support during every phase of small-scale production, from pilot to industrial synthesis.