For more than 30 years, we have been proposing and managing the development and manufacture of sterile dosage forms in glass vials (from 2R to 20R ISO formats) and in ampoules.
Our technology is based on aseptic filling following sterilising double filtering at 0.22µm, with a possible final autoclaving step (fill and finish).
Our expertise and our facilities enable us to handle a great variety of active ingredients, and in particular:
- Narcotics and psychotropic products
- Synthetic peptides
- Oily products
- WFI-grade water.
Our highly flexible equipment can produce batches ranging from 0.5 to 200 litres, which makes it possible to manufacture clinical and feasibility batches.
We can design and manufacture lyophilized vials ranging in size from 2R to 20R ISO formats.
To ensure that the freeze-drying cycle is robust and the product is stable, the proposed development will include:
- Physical-chemical properties of the formulation
- FDM-collapse temperature
- Development of the freeze-drying cycle on laboratory equipment
- Characterisation of the freeze-dried product and its morphology
- Scaling up to commercial viability.
Our workshop is flexible enough to produce lyophilized vials for clinical batches, placebos and for commercial production runs.