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New Active Pharmaceutical Ingredients Analytical Scale-up Laboratory

The laboratory offers a possibility of the development and manufacture of small amounts of commercial products in glass reactors (up to 6 kg) and enamelled reactors (up to 30 kg). A multipurpose equipment package permits the modelling of reactions in a temperature range from -20 to +200ºC and under a pressure of up to 5 bar. An autoclave allows reductions to be carried even in strong acid conditions.

A lyophilization section allows lyophilizing up to 2x50L of solution.

Automated methods of equipment washing ensure clean equipment and an automated function prevents the possibility of contamination during the passage of different products.

 A modern scrubber system enables the removal of gases and harmful substances, formed during the processes, making the laboratory an environmentally-friendly facility.

New technical equipment and trained staff ensure the manufacture of products according to the requirements of GMP (Good Manufacturing Practice).

Analytical services are performed within GLP framework.

Fact sheet

Presentation (pdf, 1.8 Mb)

Virtual tour



Analytical Scale-up Laboratory Equipment
1. Unit two enamelled reactors – 160 L
2. Unit two enamelled reactors – 50 L
3. Unit stainless steel reactors – 50 L and 160 L
4. Unit two glass reactors – 25 L
5. Unit lyophilizing device up to 50 L
6. Hydrogenation Unit 20 L stainless steel reactor p > 40 bar, temperature range from (–15) to 130 0C, 20L enamelled reactor p > 25 bar, temperature range from (–20) to 130 0C
7. Sedimentation Unit enamelled reactors – 160 L and 400 L
9. Clean room three enamelled reactors – 50 L and 2x160 L, two glass reactors – 25 L, stainless steel centrifuge, cone-shaped dryer and clean premises (C5 class)
Services
  • Transferring technologies from laboratory volumes (retorts) into manufacturing volumes (reactors)

  • analytical study and characterization of substances prior to the start of production cycle

  • manufacture of small amounts of commercial products in glass reactors (up to 6kg) and enamelled reactors (up to 30kg)

  • manufacturing in accordance with the requirements of cGMP Practice
Additional services
  • development and optimisation of synthesis in laboratory

  • development of the documentation of Active Pharmaceutical Agents (ASMF) in CTD format for Active Pharmaceutical Agents

  • cooperation with the Institute of Organic Synthesis, University of Latvia and Riga Technical University for the purpose of solving problematic issues

  • full analytical equipment of the process (including validation methods) is performed by means of:

    • HPLC (including UV, MS, LSD, refractometrical detection);
    • NMR;
    • DSC,
    • PXRD;
    • IR;
    • UV;
    • Elemental (CHN);
    • atom absorption spectroscopy;
    • including validation of methods in GMP or GLP certified laboratories.

  • Stability testing of active substances.