Sterile Forms
Manufacture of sterile liquid and lyophilized vials - Fill & Finish process
Fill & Finish Aseptic filling
We are developing and manufacturing sterile products in glass vials (from 2R to 20R ISO formats) and in ampoules.
Our technology is based on aseptic filling following sterilising double filtration 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 produce batches ranging from 0.5 to 200 litres, which makes it possible to manufacture clinical and feasibility batches.
Lyophilized
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:
- Formulation
- Physical-chemical properties of the formulation
- FDM (Freeze Dry Microscopy) 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 or commercial batches and placebos.
More from Lundbeck CDM services
With flexible and highly effective manufacturing facilities, our teams of specialists offer support and guidance in the development and industrialization of your medicines.
Our production systems meet current safety, environmental and quality standards, with recognized procedural knowledge in the development and manufacturing of tablets and micro-tablets.
Our Quality and HSE Management Systems guarantee our customers high standards of quality, safety and performance.