Validation - Qualification
We create safe, efficient processes for industry
Sterilization and packaging processes need to be validated in accordance with applicable standards and regulations. We are at your disposal to implement the most effective solution.
Validation provides our customers with the assurance that the process developed is both efficient and reproducible, guaranteeing them consistent quality.
We perform a validation to prove and document the efficiency and reproducibility of the process, ensuring its compliance with the requirements of all applicable standards, as well as with our customers’ criteria.
We support you with comprehensive and advice on :
Packaging process validation
We carry out validation using specific materials, to ensure a reproducible method for obtaining sterility barrier systems meeting predefined acceptance criteria according to NF EN ISO 11607.
Sterilization process validation
We validate a given family of medical devices according to the requirements of NF EN ISO 11135 for ethylene oxide sterilization and NF EN ISO 17665 for moist heat sterilization.
Every time we establish a partnership with a new customer, our team of experts is committed to leading and perfecting the validation process.
By working closely with our customers and drawing on our shared knowledge and experience, we strive to develop the most optimal and secure process possible.
