Performance qualification
(electron beam) |
Qualification is the proof that during the process the dose absorbed by the product allows it to obtain
the expected results.
It is performed in accordance with Good Manufacturing Practice (GMP) and with current standards
relating to radio sterilisation (EN 552, ISO 13485, ISO 9001).
Qualification enables to check the distribution of the dose absorbed inside the packaging for a given
configuration of the product (description of the packaging and position of the treatment containers
around the source).
This operation determines the acceptance criteria for the routine treatment.
Performance qualification is carried out by the customer after any modification of the beam geometry
or any change in the conveying system that can involve changes in the distribution of the dose absorbed.
Performance qualification is carried out by the Quality Department of Chaumesnil.
It must be carried out for any changes in the treatment or product parameters since the first industrial treatment.
The ISO 11137 and GMP recommend that this performance qualification has be performed three times.
