The initial validation of a sealing machine is an essential component of quality assurance in the reprocessing of medical devices. The requirements for process validation are specified in the DIN EN ISO 11607-2 standard and serve to demonstrate a reproducible and safe sealing process.
As part of the validation process, we inspect all relevant process steps of your sealing machine as well as the quality of the resulting seal seams.
Scope of Initial Validation
Installation Qualification (IQ)
- Inspection of the installation in accordance with the manufacturer’s specifications
- User instruction and training, including documentation
- Review of maintenance and calibration schedules
Operational Qualification (OQ)
- Execution of the heat-sealing process in accordance with the manufacturer’s technical data
- Test seals using the recommended limit values
- Sterilization of the prepared samples
- Verification of quality characteristics using:
- Visual inspection with Seal-Check
- Seal integrity test
- Peel test
- Seal strength testing by an external testing laboratory
Performance Qualification (PQ)
- Determination of the most critical packaging configuration
- Documentation of sterilization batches
- Testing of 3 samples of the same material in different sterilization batches (also possible within a single batch upon agreement)
Seal strength testing in the testing laboratory
Seal strength testing is conducted by an external testing laboratory as part of the validation process. For this purpose, the sealed and sterilized samples are sent to the laboratory and subsequently evaluated. The turnaround time is typically about 10–14 days. Once the laboratory results are available, you will also receive a validation report.
