Raise Your IQ: Characterizing Packaging Equipment Input Variation During Initial Validations Reinforces the Future Process

In medical device packaging, the nylon pouch heat sealing process has the potential to be affected by multiple sources of variability. Millstone’s study reveals that controlling temperature fluctuation is key to maintaining consistent peak peel strength results thus establishing confident processes. Reducing variability by stabilizing sealing temperature can be achieved by using dual bar heat sealers which yields highly consistent peel strength which leads to high process capability. Millstone’s study emphasizes the importance of performing in-depth studies on equipment during the IQ phase to rule out process variability due to the equipment up front – saving time and cost of potential re-validation in the future.