When to Involve Your Package Testing Lab: The Right Answer Might Surprise You

Most medical device companies engage a package testing lab when the design is frozen and the timeline says it is time to validate. By then, the decisions that determine whether validation goes smoothly — material, format, seal geometry, sterilization modality, shelf-life claim — are already locked. The right time to involve a lab is earlier than most teams think, and the reason is cost and schedule, not formality.

The late-engagement trap

When a lab first sees a package at validation, it can only test what exists. If the design has a problem — a seal path prone to channels, a device geometry that abrades the barrier, a material that ages poorly, a configuration count with no bracketing rationale — the lab finds out by failing the test. Now the team is in a design-test-redesign loop: change the package, re-sterilize, re-age, re-run the battery. Each loop is weeks of chamber time and another set of consumed samples. The validation that looked like an 8-to-12-week project becomes two or three of those back to back.

Engage during packaging design

The highest-leverage moment to involve a lab is while the packaging is still being designed. A lab reviewing the design against the ISO 11607 battery can flag the issues above before they are cast in tooling: it can steer the material and format toward well-characterized, testable choices, simplify the seal, confirm the sterilization sequence, and shape a worst-case bracketing strategy so you validate brackets instead of every variant. This is engineering review, not testing, and it is inexpensive relative to a failed validation round.

Engage when the shelf-life claim is set

The shelf-life claim drives the longest part of the timeline. Bringing the lab in when the claim is being decided lets you match the claim to actual commercial need and plan the accelerated and real-time aging tracks from the start — including starting the real-time study early, since it runs for the full claimed life regardless of when you begin. A real-time study that should have started a year ago cannot be recovered later.

Engage before sterilization is finalized

Because test articles must be sterilized with the production modality before aging and distribution, the sterilization decision and the package validation are linked. Aligning them early — ideally with sterilization and testing under one roof, as at the Boulder BioMed campus — removes the logistics and chain-of-custody gaps that otherwise appear between a contract sterilizer and a separate test lab.

The surprising answer

The right time to involve your package testing lab is before you have a final package — during design, when the claim is set, and before sterilization is locked. Engaging that early feels premature, but it is the cheapest insurance available against a multi-round validation. Boulder Package Testing works with engineering and quality teams during design specifically to keep validation to a single, clean round.