Gamma & Electron Beam

Course Outline This engaging and interactive course is designed for individuals with an interest in the irradiation process who are looking to gain a good understanding of the subject. It covers the practical aspects of the process and the detailed regulatory requirements necessary to achieve compliance to the three Medical Device Directives and EN ISO 11137 series. The course will explain the different microbiological sterilisation validation methodologies that can be used to establish the minimum dose, method 1, method 2 and VDmax for medical devices and describe what you have to do when things go wrong. In addition to the microbiological sterilisation validation, the process validation or dose mapping will be discussed and we will explain the determination of the minimum and maximum dose delivered during dose mapping validations. The ongoing manufacturers’ obligations for ensuring that their facility is in microbiological control is an important part of the continued monitoring for sterility effectiveness, and will be discussed in detail along with helpful advice for determining dose audit families. Irradiating products using gamma or electron beam impacts on all aspects of medical device design, manufacture and packaging. We will look at polymer and material selection, implications for packaging and any potential long term impacts post treatment.

Topics covered

  • Background to single-use medical devices
  • Detailed explanation of the irradiation process
  • Microbiology of irradiation sterilisation
  • Insights into EN ISO 11137 series
  • Process validation – how the process is validated
  • Product validation – how the product is validated
  • The regulatory framework within which the process operates
  • Possible issues with the use of irradiation
  • Impacts of the process on the device

Course outcomes
At the end of the course, delegates will gain an insight into:

  • Medical device sterilisation
  • The irradiation process – gamma and electron beam
  • Impacts of the process on the device
  • Microbiological validation – dose establishing and auditing
  • Process validation – dose mapping
  • Various regulatory requirements for the process
  • Release criteria for the process
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