The packagematerials used and the packaging machine must effectively protect your products for shelf life..
This process is valied using the standard of conditions for packaging ts EN ISO 11607-2-Medical devices – finally sterilised – part 2: Formatting, sealing and consolidation processes.
Samples taken in different parameters from the devices are analyzed in our laboratories and all results are reported.
The following steps are followed for packaging validation work;
- Preparation of validation protocol,
- Determination of critical process parameters and taking samples accordingly,
- Determination of optimal conditions as a result of critical process parameter operation,
- Process controls with optimal conditions determined (pre-sterilization, after sterilization, after consecutive double sterilization),
- The preparation of the packaging validation report tells you along with the results of the whole process.