Maximum security and reproducibility.
Any processes where the end result is not 100% checkable must be validated to prove their reproducible quality. This affects the cleaning, packaging and sterilisation processes: in order to prove functionality and sterility, the package will have to be opened irreversibly, with the resulting loss of sterility and saleability. The duty of proof that all the regulatory/standards requirements have been fulfilled lies with the distributor of the medical product. We therefore collaborate with the distributor to produce a validation plan that is appropriate for the actual risk situation. The following is an overview of the most common validation checks:
- Validation of the cleaning process (particles, chemical residues, contamination, etc.)
- Validation of the packaging process (sealing, sealing seam strength, burst test, etc.)
- Validation of the sterilisation process (proof of the efficiency of the sterilisation process for a variety of load and dosage ranges)
- Bio-compatibility (proof that the medical product and packaging do not cause any reciprocal or unwanted reactions with respect to the patient’s organism)
- Stability studies (proof that the service life of a medical product lasts for the entire storage period of that medical product = “shelf life”)
- Validation of the transportation process (simulation of any effects caused by transportation, impact, climate, etc.)
Validation is time intensive (particularly stability studies!) and may take several months. This may extend the “time to market” and must be taken into account at the earliest stage.