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SERVICES WE OFFER:

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)

 

RADIATION MONITORING RESULTS:

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

CERTIFICATES AND LICENCES

We have acquired a cerificate for ISO 13485 (special Q/A rules for the medical industry that include basic Q/A rules of ISO 9001/2000) with reference to ISO 11137 (rules for validation of products). ISO 11137 also includes standards EN 552 (rules for irradiation) and EN 556 (definition of the term sterility). The system will also be compatible with the FDA 21 CFR Part 820 QS Reg. GMP. The certification company is Bureau Veritas Denmark.

The installation qualification (ISO 11137) has been conducted by Dr. Arne Miller as the head of the High Dose Reference Laboratory in Risö, Denmark.

 

Download ISO 13485 Certificate