Lyophilisation / Freeze-drying
The installation of a freeze-drying unit is a further expansion of the technological capabilities of the Graz plant. Freeze-drying or lyophilisation is especially important for medicines that are not sufficiently stable when dissolved in water. It means they can be stored in a dry form. They are then redissolved in water shortly before being given to the patient.
Our freeze-drying capability ranges from laboratory-size batches to large-scale production and covers the container formats from 2 mL (2R vials) up to 30 mL.
Prefilled syringes complete the range of container types and sizes that are handled in the Graz plant. The ready-to-use containers make it easier to apply injectables, minimizing the risks of contamination and mix-ups. Our filling line is designed to handle glass and plastic syringes from 0.5 to 50 mL, providing maximum flexibility for the requirements of different products.
The complete range of primary containers includes:
Vials, glass 2–50 mL
Bottles, glass 50–1000 mL
Pre-filled syringes, glass 0.5–20 mL
Pre-filled syringes, plastic 0.5–50 mL
Ampoules, glass 1–20 mL
Bags, flexible non-PVC, single and multi-chamber 50–3000 mL
Aseptic manufacturing processes must guarantee product sterility and safety without terminal end sterilization. This puts the highest of quality demands on the manufacturing plant, processes and personnel. To ensure sterile filling environments, we use closed RABS systems sterilized with hydrogen peroxide. The sterility of the process is backed up by continuous microbial monitoring and regular media fills.
Products which can withstand the required heat limits are terminally sterilized in water spray autoclaves. Highly configurable autoclaving programs, including rotating and static operation, enable us to adapt the process specifically to the individual products and container forms. This provides maximum product sensitivity and sterility assurance.
The plant in Graz developed the first production processes for emulsions in the 1980s. Since then, it has become one of the major manufacturers for IV drug and nutritional emulsion products. Fat emulsions require a multi-step preparation in separate phases: The phases are filtered before being mixed and are then homogenized in several runs to achieve the required oil droplet size distribution.