Technical Information

The download available here describes the process followed by Ionisos Ibérica to validate the sterilization process of healthcare products. The validation process followed conform to and are in accordance with the applicable Stanadard ISO 11137:2006.

The validation process consists of the following stages:

• PROCESS DEFINITION: the determination of the sterilization dose and definition of the maximum acceptable dose

• PERFORMANCE QUALIFICATION: dose mapping exercise

At Ionisos Ibérica we aim to support our customers and we do this by ensuring that products are correctly validated to comply with medical device and pharmaceutical manufacture requirements and standards.

Validation process (PDF doc)