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.
Multiple Buchi Autoclaves for hydrogenation and pressure reactions
Hot stage Microscope
Evaporative Light Scattering Detectors
In situ NIR monitoring probe
Headspace on-line FT-IR
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
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)
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.
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.