January 19, 2018

Mini Guide To Sealer Validation

The best first step to success in developing proper sealer validation parameters is reading the equipment manual.  In spite of almost universal aversion to instruction manuals, they really are the logical resource to understanding the machine’s capabilities, settings and recommendations from the manufacturer.  At the very least, a read-up makes it easier to ask the right questions.  With sealers, one of the first questions you’ll want to know the answer to is, “What are the critical seal parameters?” To find out, you must first create some samples and complete “dry runs” at different settings.  Record how the samples perform:

  • 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.