From chemicals to pharmaceuticals
Zach System
Manufacturing
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
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.