From the equipment point of view, there are ways to improve the process and reduce the variability and noises that can cause your process to drift or be out of control; even when sealing process parameters are not changed.
You may think that your process inputs are well controlled and monitored, but depending on how they were designed to work, they can cause the sealing process to change or drift over time without even knowing it, until a failure occurs.
You want the first sealing cycle to be the same as the 1,000 one. Process repeatability and reproducibility is critical; not only from the validation perspective, but also to make sure the process will remain stable and under the validation status over time.
At Mavajan Packaging Solutions, we work together with our clients to develop a well robust equipment design process to help mitigate, improve and overcome these design issues.