Cleanroom certification and validation are two terms that get confused a lot.
They’re related, yet refer to different things.
In this article, we’ll explain what each one means, how they differ, and where qualification fits in.
What Is Cleanroom Certification?
To put it shortly, certification is a test.
More specifically, it’s a formal and periodic test that confirms your cleanroom meets its assigned ISO classification.
Typically, a third-party testing firm comes in with special instruments to measure things like particle counts, airflow, pressure differentials, temperature, and humidity.
They then compare those results against the requirements of your ISO class.
If everything passes, you get a certificate. And if you don’t pass, you get a report telling you what needs to be fixed.
You can imagine certification as a kind of snapshot that tells you, at the time of testing, whether the cleanroom met its classification. That’s pretty much it.
Also, it’s worth noting that certification is not a one-time thing. Cleanrooms are reclassified on a regular basis.
ISO 14644-2 calls for periodic classification testing annually, although the interval may be extended depending on factors like risk assessment and ongoing monitoring.
Any major changes you make to the cleanroom afterwards will also trigger retesting.
What Is Cleanroom Validation?
Validation, on the other hand, goes much further than certification.
Where certification asks whether a cleanroom has met its classification, validation asks whether the work being done in a cleanroom can be relied upon to produce safe and consistent results.
In other words, validation is documented proof that the entire process running inside the cleanroom, including the equipment, procedures, personnel, and environmental controls, consistently deliver the intended outcome.
So What’s the Actual Difference?
The simplest way to put it is that certification proves that the cleanroom works, while validation proves that the processes work.
You certify a cleanroom to show that it meets its ISO class, and you validate it to show that the work happening inside it is reliable and repeatable.
A cleanroom can be certified without being validated, and it might pass every particle count and pressure test. But that doesn’t mean the manufacturing process running inside it has been proven to deliver consistent results.
On the other hand, a validated process needs a certified cleanroom underneath it. If the room can’t hold its classification, then validation doesn’t mean much.
All in all they depend on each other, but they’re not quite the same thing.
What About “Qualification”?
If you’ve been reading about cleanrooms for any length of time, you have almost certainly come across the term “qualification.” Needless to say this can add to the general confusion about certification and validation.
Qualification sits in between the two, so it’s easy to see why people mix all three up.
Qualification is simply the documented process of proving that the cleanroom’s systems are installed correctly and perform within the right parameters.
It commonly includes a few stages: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
IQ confirms everything is installed correctly; OQ confirms it works under defined conditions; and PQ confirms it performs consistently during actual use.
The difference is one of scope.
Qualification focuses on whether the cleanroom’s systems are installed and working correctly; certification focuses on whether the room meets its ISO class; and validation focuses on whether the process running inside it produces consistent results.
The Bottom Line
Certification, qualification, and validation are all part of getting a cleanroom up and running. They overlap in places, but each one answers a different question. Understanding the differences early on makes the whole process easier to manage.
