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Most people assume that once a medical device is manufactured and sterilized, it is ready to go. But there is one more layer of protection that has to be proven before anything ships: the package itself has to be validated.
At InSitu Technologies, package validation is a formal, multi-step process that follows ISO 11607, the international standard that governs sterile medical device packaging. The goal is straightforward: prove that the package keeps the device sterile from the moment it is sealed all the way to the moment a clinician opens it in the operating room, whether that is six months or two years down the road.
Here is a look at what that process actually involves.
Seal Strength Testing
The first thing we look at is whether the seals holding the package together are mechanically strong enough. Seal strength testing measures the force required to peel apart a sealed edge. We pull samples from the package at multiple points around the seal and run them through a tensile tester that records exactly how much force is needed to separate them.
This is done at multiple stages: before aging, after accelerated aging, and after distribution simulation testing. The reason you run it more than once is that a seal that passes on day one still has to perform after sitting in a warehouse through temperature swings and being stacked on a pallet. The numbers have to hold up across all conditions not just the best-case scenario.
Bubble Leak Testing
In a bubble leak test, the package is submerged underwater while being internally pressurized, and the inspector watches for a steady stream of bubbles or any ingress into the package after the test. Any bubbles indicate a gross breach in the sterile barrier, which means the package failed.
It sounds simple, and in some ways it is. But it requires a trained eye, careful technique, and consistent pressure levels to produce reliable results. This test is good at catching large defects and is typically one of the first integrity checks performed.
Dye Penetration Testing
Where bubble leak testing catches the obvious failures, dye penetration goes deeper. Dye penetration testing introduces a liquid dye into the package under pressure or vacuum to drive it through any seal channel defects, which are then identified visually. It is particularly sensitive to channel defects and pinholes that a bubble test might miss, and it works well for porous packaging materials like Tyvek®, which is common in sterile medical device pouches.
The package is opened, the dye is introduced along the seal channel, and the inspector examines the seal under light to see if any dye wicked through. If it did, there is a defect. If the seal held, the dye stays on one side.
How Many Times Do You Have to Run All of This?
This is the part that surprises people. Package validation is not a one-and-done test. ISO 11607 Part 2 requires validation through IQ, OQ, and PQ phases, followed by integrity checks after real-world challenges including distribution simulation and aging.
Before Aging
Accelerated Aging
Real-Time Aging
Distribution Simulation
In practice, that means running seal strength, bubble, and dye tests before aging, after accelerated aging, after real-time aging, and after distribution simulation. Each represents a different point in the device’s life cycle. You are essentially proving the package works at every stage—not just when it is fresh off the sealer.
For a Class III cardiovascular device like those InSitu makes, this level of documentation is not optional. The FDA treats the package as part of the device, so the validation evidence has to be just as rigorous as the device testing itself.
Why We Take This Seriously
A coronary covered stent goes into a patient’s artery. The sterile field matters enormously. If a package fails silently whether from a tiny channel defect or a seal that weakened over time the consequences for the patient could be severe.
That is why our team runs every one of these tests, documents every result, and keeps all of it on file for audits, regulatory submissions, and ongoing quality monitoring. It is not glamorous work. But it is exactly the kind of work that separates a device you can trust from one you cannot.
