Flynn C.R.,Gerresheimer |
Kraus D.,Gerresheimer |
McMaster M.,Gerresheimer |
McNerney D.,Gerresheimer |
Glass International | Year: 2011
The article explains the details of a survey that is currently underway by Gerresheimer to identify the causes of delamination and develop appropriate countermeasures. Delamination is currently a much- discussed issue, as new, highly efficient, but aggressive drug products set increased demands for their primary containers. By using a fully integrated process of producing tubes and converting them to ampoules, vials, cartridges and pre-filled syringes, Gerresheimer is creating a survey to find the sources of delamination and to develop appropriate countermeasures. For the storage of parenterals, borosilicate type I glass is the material of choice. It is inert, chemically stable and non-porous. Additionally, it is resistant to the temperature extremes seen in many drug manufacturing processes, such as lyophilisation and sterilization. Pharmaceutical manufacturing processes have many steps as well, such as washing, depyrogenation, terminal sterilization and product storage under different conditions for different periods of time.