The quality system ensures that all applicable standards are strictly followed. These are ISO 9001/2000 (basic Q/A rules), ISO 13485 (special Q/A rules for the medical industry, EN 552 (rules for irradiation), EN 556 (definition of the term sterility) and ISO 11137 (rules for a/o validation of products). In case of medicinal products, the rules in the Pharmacopoeia are also applied.The system will also be compatible with the FDA 21 CFR Part 820 QS Reg. GMP

 

Validations

A manufacturer may CE-mark his product and label it STERILE if he uses a validated sterilization process.

Firstly one must understand that it is impossible to prove that a product is sterile. It may sound strange. The explanation is that the so-called SAL (Sterility Assurance Level) shall be at least 10-6, which means that it in a batch of 1 million pieces is allowed to have only one single surviving micro organism. To statistically prove such a performance one must make at least 2 million tests, which of course is absurd. The tests are therefore made using 10-1 or 10-2 SAL-levels. Results on these levels are then re-calculated for 10-6.  There are internationally accepted methods, described in  ISO11137, for these validations.

The manufacturer is responsible for the quality of the product, including sterility. The contract sterilizer, we, assists in finding out the minimum dose required (Dmin) and the maximum tolerable dose ( Dmax). Dmin is related to the bioburden and the bioburden resistance. Dmax is set not to jeopardize the material properties in the product. In this validation process we will perform a so called dose mapping with the aims of finding where in the product package the minimum dose is to be found. Using dosimeters in a 3-dimensional grid makes this dose mapping. The process is then a base for routine production dosimetry.

The irradiation plant itself and the basic processes is annually calibrated against an international standard.

Doses