Ebeam surface sterilization of ready-to-use units
Technik
Abstract
The demand for ready-to-use syringes, vials and cartridges (also known as RTU 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 [1]. It is of crucial importance that these sterile packaged units are aseptically introduced into cleanroom class A 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, meaning that the process can definitely be described as surface sterilization. The combination of ebeam tunnel and downstream filling line isolator provides 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.
Correspondence:
Timo Krebsbach
SKAN AG, Kreuzstr. 5, 4123 Allschwil
timo.krebsbach@skan.ch
 | Dr. Timo Krebsbach looks back on 22 years of professional experience in various positions in the pharmaceutical industry: Head of Microbiological Quality Control, Head of Marketing & Sales, Managing Director of a GMP contract laboratory. Since Jan 2024, he has been working as a Strategic Product Manager at SKAN, where he is responsible for decontamination systems. In addition to his own publications, he is the editor of the 3 books “Reinraum in der pharmazeutischen Industrie”, “Reinigung und Desinfektion im |
