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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


There are three steps:

The first step is material testing. All types of materials have to be tested including glue and packaging material. A normal testing scheme is 0, 25, 50, 75 and 100 kGy. The zero-dose sample shall join the other samples during the whole trip to avoid unexpected influence caused by the transport cycle, e.g. changes due to temperature variations. Note that it is not enough to test on 25 kGy only, because the absorbed dose in the goods may vary from 25 kGy up to perhaps 50 kGy. Also, it is important for the supplier of irradiation to know what to do if he, for technical reasons, must run part of the goods twice. These parts will then get a double dose. Most medical articles can stand that, but there are exceptions.

The next step is to make a qualification. This procedure shall be carried out when the product is almost ready for production. The packing material may be the only thing remaining. In the qualification a dose mapping of the goods in the preferred packing pattern will be made. This gives information about where the minimum dose is to be expected. In many cases it will however be revealed that the goods are not optimally packed, and the alternatives are therefore discussed and a final decision can be made.

The last step is the validation. Validation takes place when the product is ready for the market. Here the place of the earlier found minimum dose will be certified. Dose mapping is again used. For statistical reasons the procedure is repeated several times. The end product is a validation document that is a part of the commercial contract. This document is also an important legal document, which you need for registration in all countries.

After running of each batch or lot a Certificate of Conformity is issued. This document is the legal means to release the product for the market.