
The demand for ready-to-use syringes, vials and cartridges (also known as RTUs or ready-to-use units) for the aseptic filling of sterile pharmaceutical products has increased significantly in recent years and is forecast to continue to grow at an average annual rate of 8.74% over the next 10 years. It is vital that these sterile packaged units are aseptically imported into Class A cleanroom conditions where filling then takes place. In order to fulfil the regulatory requirements and to be able to use a continuous process at a sufficiently high speed, ebeam technology is the ideal solution. During the transfer process, the ebeam achieves a significant germ reduction of around 12 log levels, so that the process can certainly be described as surface sterilisation. The combination of ebeam tunnel and downstream filling line isolator results in an overall aseptic concept that fully complies with the requirements of Annex 1 of the EC GMP guidelines and with which the highest possible Sterility Assurance Level (SAL) can currently be achieved.

