- Is there full adhesive transfer?
- What does the seal look like?
- Is it too difficult to open?
- Does it peel apart too easily?
Going through this exercise helps you get to know the machine and how it performs when sealing with the selected packaging materials.
Next, you’ll begin process characterization using the information you learned. To do this, follow the ISO 16775 Annex Q, Guidance on Establishing Process Parameters.
The ISO 16775 Annex Q guide will walk you through a range-finding exercise. This involves evaluating a series of recipes beginning with low energy (usually low temp/low dwell) up through high energy (high temp/high dwell).
After this is complete, you will then gather seal strength data following ASTM F88 and chart your results for visual graphs. From these results, you can determine the low and high parameters, or “process window.”
The last step is to perform a confirmation run, to build confidence in the recommended settings. You have have properly identified the process parameters of your new sealer equipment and are on the way to full operational qualification!
Reaching the operational qualification is more complex and is not generally considered a DIY, or easy in-house process, unless you have your own engineering team. Our Sealer Validation MicroProgram can minimize the lead time with our validated methods. If you are bringing new equipment in house, we can talk you through what to expect. Feel free to live chat or CONTACT US.
Discover more articles
PRESS RELEASE: PCL Hires Jenn Goff as the VP of Sales, Marketing, and InnovationRead More
PRESS RELEASE: PCL Welcomes New CFO, Bernadette LegarettaRead More
The Tried-and-True ASTM F88 Standard Gets a RevisionRead More
4 Tips for Launching Your First Medical DeviceRead More
Packaging Compliance Labs Completes Partnership with SV Health Investors to Accelerate Continued GrowthRead More
PCL Team Recaps Favorite Sessions from the[PACK]out 2023Read More