1 Center for Nuclear Technologies, Technical University of Denmark2 Radiation Physics, Center for Nuclear Technologies, Technical University of Denmark3 Cilag J & J4 unknown
This Guide describes the validation and routine monitoring of microbiological decontamination of surfaces by low energy electron beams (100-200 keV). The Guide is mainly based on experience gained in connection with installation of electron beam systems for surface decontamination of pre-sterilized containers at several aseptic filling lines at pharmaceutical manufacturers. Its main emphasis is on the dosimetric measurements that should be carried out for the validation of the decontamination process and on establishing the appropriate effective dose. Other aspects such as use of measurement uncertainties and formation of radiation induced by-products are also addressed.