RISE Surface, Process and Formulation – RISE SPF – is part of Research Institutes of Sweden, a multidisciplinary national research institute.

RISE SPF is focusing on research and development within the areas of surface design, chemical processes and formulation science. The staff has extensive experience from the pharmaceutical industry in development of chemical and formulation processes from early stages to commercial manufacture.

RISE SPF has a close collaboration with NiTech Solutions in performing feasibility studies on continuous crystallisations and continuous chemical synthesis. The services include:

Laboratory trials, using a NiTech® evaluator and a NiTech® DN15 unit;

Proof of concept for continuous trials; Proof of process for continuous processes; Crystallisations by cooling, reaction or antisolvent

addition and fast chemical reactions are examples of suitable operations for investigation;

Access to full analytical support during the development in terms of chemical analyses, particle size measurements and solid state characterisations. This makes it possible to get very fast analytical answers to support the trials;

In-line measurements as: FTIR, Raman and Lasentec® FBRM. NiTech® DN15 continuous crystalliser

The team for continuous studies

Recently a successful investigation of a reaction crystallisation process was performed for a pharmaceutical company. It started with a proof of concept study in the NiTech® evaluator and continued with continuous trials in the DN15 unit. The results were promising and the next step is to scale up and run the process on a larger scale. The project was carried out in cooperation with NiTech Solutions, Alconbury Weston Ltd and the pharmaceutical company in question.

Light microscope picture of crystals

Laboratory batch reactor and pilot plant reactor

RISE SPF also performs extended and more thorough investigations of chemical- and crystallisation processes, such as: polymorph-, salt- and co-crystal screening, and development of chemical synthesis and crystallisation methods in general as well as formulation methods. On site, we also have a pilot plant (reactors up to 100 L) for manufacturing of GMP and technical-quality material as well as formulated products.

Examples of available analytical tools:

• XRPD – X-ray powder diffraction• DSC– differential scanning calorimetry• TGA – thermal gravimetric analysis• SEM – electron microscope• Malvern-size analysis• DVS – dynamic vapour sorption• TAM-microcalorimetry• Polarized light microscopy with hot stage • BET – gas sorption (specific surface area and

porosity) • Structure informatics and single crystal

determination (SXRD)• Chemical analysis by all standard techniques e.g

GC, HPLC, UPLC, GCMC, LCMS, KF, Ion Chromatography (IC) and NMR etc.

XRPD diffractogram