Irradiation services

We offer our customers the opportunity to sterilise their products by having them treated in our systems.

A selection of products for which we offer sterilisation:

  • Medical devices
  • Raw materials
  • Packaging materials

Our plants are designed for very specific product groups and thus have equipment that enables optimum handling. This ranges from special single part and pallet transport systems to winding systems for cables and pipes that can be used in a variety of ways.

Sterilisation is the elimination of all living microorganisms on materials and objects. All micro-organisms contained in or adhering to the material, including their resistant dormant bodies (such as spores) are killed off. Sterilisation using ionizing radiation has been known for over 30 years. However, since systems with a high level of energy (10 MeV) and an associated deep level of penetration have reached the market, sterilisation is increasingly carried out using electron beam (beta rays). Electron beam sterilisation is an approved method for medical devices and described in the standard ISO 11137.

The benefits of sterilisation through irradiation

Sterilisation by radiation has undisputed advantages over other methods, such as the appliance of heat or chemicals (gassing):

  • It is a cold process, so that it also suitable for heat-sensitive products.
  • The process has a high level of intrinsic safety
  • Fast throughput rates
  • The irradiated products can be released with ease and are immediately available for use without further testing (no quarantine)
  • Treatment in complete boxes (beta)
  • Even sealed packages can be treated
  • Simple documentation and validation of the process
  • Widely accepted and recommended method
  • Electron beam sterilization has the specific advantage of being energy efficient an not requiring any radioactive source

Standards

Sterilisation through irradiation is a standardised process. Important standards in this case are, for example:

  • ISO 13485 Quality Management for Medical Devices 
  • ISO 11137-1 Sterilisation of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 11137-1:2006) 
  • ISO 11137-2 Sterilisation of health care products – Radiation – Part 2: Establishing the sterilisation dose 
  • ISO 11137-3 Sterilisation of health care products – Radiation – Part 3: Guidance on dosimetric aspects

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Sterilisation

with 10 MeV electron beams

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