PCL has had the opportunity numerous times to work with clients at validating their sealer and pouch/trays so that they are capable of running on a production line. The process of validating a sealer and package involves many steps. The first step is to properly install the sealer (IQ). But before starting the operational qualification (OQ) and process qualification (PQ), there is one important step that needs to occur. This step is process characterization. The purpose of process characterization is to prove that critical product parameters and associated process parameters are capable of meeting certain requirements. Typical requirements involve the seal strength, seal width, and visual characteristics.
Process characterization is critical in determining the optimum settings for the sealer to run at for OQ and PQ validation. The first thing to do is read through the sealer operations manual and begin conducting “dry runs” to understand the behavior of the sealer. Next is to define the critical process parameters. Time, temperature, and pressure are typically the critical parameters for sealing. Once the critical parameters are determined, a range-finding exercise as outlined in ISO 16775 Annex Q is performed. This exercise involves a series of recipes beginning with low temperature and low dwell time, and working your way up to a high temperature and high dwell time. Seals are then tested for strength and visual characteristics with results placed on a line graph and assessed to determine optimum ranges. Once you have found your recommended high and low parameters, a confirmation run is performed at those settings. This confirmation run is to confirm that the recommended settings will output a successful seal. This completes the process characterization step. Next up is sealer validation, which is the first pillar in our ISO 11607 Guide.