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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


All packages contain air which when irradiated will be ionized creating ozone. A dose of 25 kGy will give a concentration of 100 PPM inside a normal package. The half-life of ozone is short, about 1 hour. The rate of ozone will therefore decrease to 1 PPM in 7 hours. Ozone is by itself a sterilizing agent.

Irradiation is basically a cold process. The increase in temperature is in gamma less than 5oC but can in beta be considerably higher especially if there are metals involved. Before routine production, the temperature parameter should therefore be checked.

Most chemical reactions work better in moisture. The radicals, produced in an irradiation process, are also chemicals. They can in moisture move more freely and the sterilizing effect will increase. On the other hand the microbes will also enjoy life better and subsequently multiply themselves. These two factors work against each other. Uncontrolled growth of microbes must be considered worse. Wet products, like eye rinsing water, should therefore be sterilized within a few hours from filling or be kept at low temperature (+4oC) until it is possible to perform the sterilization.

Certain pharmaceuticals will be unacceptably hurt by irradiation. In such cases it may be possible to irradiate under extremely low temperatures, down to -196oC (liquid nitrogen). Low temperature is however not the whole trick. A slow freezing rate is more important. But correctly made, it is possible to sterilize drugs such as insulin. Deep freeze temperatures can be maintained in the slow gamma process. Low temperature is a specialty of the speedy beta treatment.