Facilities & Equipment

Laboratories

The process (6) development, safety assessment (1) and analytical (2) development labs have a modern infrastructure and are continuously upgraded to the latest trends in occupational exposure. To keep up with industry trends the process development labs have specific instruments that allow to proactively treating specific issues as well as gathering the maximum of data from experiments on lab and pilot plant scales. 

            Lasentec Apparatus
            Multiple Buchi Autoclaves for hydrogenation and pressure reactions
            Hot stage Microscope
            Stereo Microscope
            Evaporative Light Scattering Detectors
            In situ NIR monitoring probe
            Headspace on-line FT-IR
            High Containment labs (for compound with OEL down to 0.1µg/m³/8h shift)
            Corrosion test set-ups 
            Parallel synthesis units (eg for preparation of validation: determination of normal
               operation and proven acceptable ranges NOR/PAR)
            Preparative HPLC (for impurity isolation and development of preparative
               separation processes) 
 
 A dedicated team evaluates the safety of each process prior to scale up to the pilot plant. Heat of reaction, build-up of energetic intermediates, gas-formation, thermal stability of reaction mixtures, evaporation residues, wet and dry cakes are evaluated.
 

Standard in house tests include:

            Micro-reaction Calorimetry (available on several sites)
            DSC (available at several departments)
            RC-1 Calorimetry 
            Accelerated Rate Calorimetry
            Carius tube testing
            BAM Fallhammer (Shock sensitivity)
 
Other tests may be performed externally after agreement of the customer.
 
The analytical development team provides a series of specific services to internal and external customers:
 
            Development and/or review of analytical methods for in process control,
                raw materials, intermediates and target product. 
            Reference characterisation 
            Impurity isolation and identification (using GC-MS and LC-MS)
            Analysis of lab samples, including certification.
            In process control analysis on batches ran at pilot scale and analytical release 
               of pilot plant product 
 
 
            Validation or cross-validation exercises as required
            Stability studies according to ICH Q7A guidelines 
            Advise on monitoring of toxic byproducts
            Analytical support to troubleshooting of regular manufacturing 
 
Our analytical labs have good contacts with several universities allowing application of additional analytical techniques after agreement of the customer (eg. High Resolution Mass Spectrometry)
 
Standard documentation for custom manufacturing includes:
 
             Process development reports
             Analytical development report
             Safety assessment report
             Environmental assessment report / report on best available technology
             Raw material user testing report 
             Copies of pilot plant batch records

All R&D reports are redacted in English.