Sterilization

The main application for our plant is sterilization of medical supplies. The term "sterilization" is defined by international bodies and is highly regulated. The definition is that a sterilized product may not have more than one surviving micro organism per one million articles, e.g. syringes. This is an extremely hard demand and an excellently working Quality Assurance management is needed. Note that it is mathematically impossible to test that a product has achieved this high degree of cleanliness. To make a test that gives significance, one will need at least two million tests, which certainly is impossible. Instead the bioburden is tested at a very small dose and the result at the normal sterilization dose is then calculated. However, it illustrates the importance of Quality Assurance.

Normally the customer has own routines for bioburden checking. Nevertheless, if the customes prefers we are happy to organize such testing in co-operation with a certified laboratory in Tallinn.