Views: 8 Author: Site Editor Publish Time: 2023-07-22 Origin: Site
Vacuum Freezer Dryer application in Development and production of bio-pharmaceuticals
Bio-pharmaceuticals are medical substances made from genetically modified organisms through biotechnology. They are particularly complex molecules and therefore sensitive to the temperature. Bio-pharmaceuticals are a key driver of growth in the pharmaceutical and bio-tech industries.
About 60% of these substances, such as substances and antibodies specific for the treatment of cancer, require extremely gentle drying via the lyophilization process in order to achieve an adequate shelf life.
In this context, the preparation of medicinal substances in vials is commonplace in the pharmaceutical industry, with the special feature of low concentration of the active pharmaceutical ingredient (API) per dose. In many cases, only a few milligrams of material are added to the matrix material. Freeze-drying small batches of these more unique active substances requires a freeze-dryer of small to medium size, typically using an area of 2 to 4 square meters. Due to the high value of these products, the requirements for system reliability and technical implementation are extremely stringent.
Aseptic production in the entire process chain requires fully automated loading and unloading in isolators as well as in steam-sterilized freeze-dryers.
· Vial filling with wash and stopper inserted
· Disinfection tunnel
· Filled with active ingredients
Freeze drying on 2 parallel lines with fully automatic loading and unloading
· Vial closure / flanging