The manufacturing operations currently carried out at the site comprise the production of non-sterile products / solid dosage forms - capsules and tablets. The site is also authorized by the Portuguese Health Authority to produce semi-solids, liquids for internal use, suppositories and investigational medicinal products.

The main operations that lead to the production of solid dosage forms with the required quality include:

  • Dispensing/Weighing:The direct connection between the dispensing rooms and its different scales with SAP-ERP system allows the operators to safely dispense the right approved batch and also the exact amount of each raw material and active substance. Also the yield of different stages of manufacturing is calculated and evaluated with the same SAP interface support.

After being weighed, raw materials may follow two routes: direct mixture or (wet/dry) granulation.

Mixture / Granulation: Bluepharma has 2 blending rooms, equipped with BOHLE mixers, which allow the homogenization of powders or granules held inside BOHLE containers, in an effective and smooth rotational movement (~6rpm), enhanced by the counter-current principle (possible by the baffles placed inside the container). The choice of the container and of the blending time depends on the quantity and volume of powder, determined when each product is validated. Containers with a volume from 100 to 2000L volume may be mixed, ensuring that the active substance and excipients are evenly distributed in the end, thus assuring a great flexibility of batch sizes. Bohle containers also allow each product batch to be safely transported and stored.

  • Bohle PM 1000 - with a blending capacity from 100L up to 1200L
  • Bohle PM 2000 - with a blending capacity from 800L up to 2000L

Bluepharma additionally has capacity for:

  • Dry granulation, using an Alexanderwerk WP 50 compactor.
  • Wet granulation, via two wet granulation lines, with na approximate capacity of 250 L, consisting of a LODIGE MGT 250 +ALEXANDERWERK R300 +GLATT WSG 60 - high shear mixing + fluid bed drying or fluid bed granulation) and 600L (new suite GLATT VG600 + WSCombo 450 - high shear mixing + fluid bed drying; fluid bed granulation; Wurster process).

These processes originate granules that present homogeneity and adequate properties for its subsequent tabletting or capsule filling. These processes are fed by gravity action from an upper level floor and driven by state-of-the-art controlled equipments.. The in-process-controls (IPC) performed at every stage ensure that the manufacturing process is always under control and all necessary parameters are rigorously met, thus guarantying the final quality of the product, whether it is tablets, coated tablets or capsules.