Eesti keel   Русский   English



Medical Device Sterilization

Bioburden reduction of consumer goods:

  • cosmetics
  • spices
  • herbs
  • toiletries
  • pharmaceutical raw materials
  • food packaging
  • dyes and colorants

Industrial products processing



Background radiation measured on the exterior wall of Scandinavian Clinics Estonia OÜ´s plant (μSv/h):

(Natural background radiation in Estonia may reach up to 0,3 μSv/h)



Survey area: 0,12 µSv/h;
Control area: 0,10 µSv/h;
Pool: 0,08 µSv/h


Industrial irradiation has been used during the last 50 years for a multitude of purposes. The main application is for industrial sterilisation of medical supplies and this method is worldwide the preferred method of irradiation. Other methods are gas (ethylene oxide) and steam (autoclaves).

Outside the medical field, irradiation may be used to increase shelf life of food by decontamination. Irradiation is also used for cross-linking of certain plastics, mainly polyethylene, thereby introducing resistance against heat, mechanical wear and biodegrading. Even the difficult waste problem of handling Teflon (PTFE) scrap, mainly from cable manufacturers, by converting it to a powder, reusable in the smear industry, is a field for irradiation.

Irradiation plants are sophisticated both in technique and from a quality assurance point of view. Quality and safety of the plant are in every country controlled by the National Radiation Protection Board or a similar agency.

If there is a choice most medical device manufacturers will usually prefer irradiation. 55% of the world production of medical disposables is today sterilised by irradiation.

The main argument for irradiation is that the beam penetrates the material, so there is no need for a design that allows for gas or steam penetration. Another factor is that irradiation does not create toxic residuals. A very important parameter is the freedom of choice regarding packing material. It means that plastics (polyethylene) can be used. This is not possible for EtO and steam. Irradiation is also a cold process compared to the alternatives, i.e. no thermal problems for the materials involved. If PTFE (teflon) is used, the choice must be EtO or steam, because this material will be converted to a powder in an ionizing field.