Packaging / Heat Sealer Validation - IOQ (Installation/Operational Qualification)

Our company has acquired a heat sealer for packaging.

I am aware of packaging validation test like tensile strength, dye penetration, and burst. I believe testing for 2 of the 3 requirements is sufficient.

My questions are:

Is an IOQ required for the heat sealer or can performing a validation study on the packaging be suficient with a calibrated heat sealer?

What are the reason for validating the heat sealer (if i intend to test the integrity of the packages)?

If IOQ is required for the heat sealer, would the packaging test (tensile, dye, and burst) be the test for the operational qualification?

Am not sure if this is relevant for you but should add further knowledge (there is a sample for heat sealer in the annex): Quality Management Systems - Process Validation Guidance from GHTF

IQ is a systematic way of ensuring the system is properly installed. It's feasible that you could install it incorrectly, it works for a while (your packaging tests) and then begins to fail. So I would not consider just package testing sufficient to indicate correct installation.

Similarly, OQ will confirm that it meets all your requirements. This would include temperature ranges, materials used, etc. I would think that your packaging tests could at least partially satisfy the expectations of an OQ but not fully.

Finally, I'm curious why you didn't mention PQ? How do you know the system will perform consistently for your expected use (shift time, etc.)?

My preference is to perform a single study that meets requirements for heat sealer process validation (per ISO 11607-2:2006) and packaging validation (per ISO 11607-1:2006). Both types of studies are required to conform with these standards. A single combined study is more economical than performing 2 separate studies.

The combined study includes IQ, OQ (high and low runs), and 3 PQ runs, with all test articles (dummy packages) exposed to the routine sterilization process (2 times perhaps), climatic conditioning and distribution simulation (per ASTM D4169 for example), and accelerated and real time aging (per ASTM F1980).

From my perpective IQ is primarily entering the heat sealer into your calibration/maintenance program and testing alarm limits or any other special features.

Make sure you calibrate heat sealer time/temperature/pressure to bracket the settings (including tolerances) specified in your work intruction. Also, I recommend selecting OQ high/low setting to account for measuring inaccuracy in addition to the work instruction tolerances. For example, if temp spec in work instruction is 250+/-5 and calibration accuracy is +/-2, I would use 243 for OQ lower limit and 257 for OQ upper limit.

The typical inspections/tests performed are visual (non-destructive) seal inspection, seal peel strength (ASTM F88), and at least one whole-package integrity test (like bubble test per ASTM F2096, for example). Dye penetration testing per ASTM F1929 is really intended as a seal integrity/leak test. I don't believe it qualifies as a whole-package test since the focus is on the seals and not the package substrates (i.e., webs for peel pouches, tray/lid for lidded trays).

Hope this helps.

Thanks, Sam. I appreciate your post.

Completely agree with Sam there - IQ OQ & PQ is moke likely required, especially if there's no existing validated equipment that is equivalent.

And to re-iterate Sam's very detailed response, validation in not about testing end results of the process in normal operation, it's about testing the limits of the process and then ensuring it is consistent in normal operation.

(The limits of the process can be different permutations of all the process variables - potentially including raw materials, process parameters and environmental conditions)

Sam Lazzara said:

The combined study includes IQ, OQ (high and low runs), and 3 PQ runs

Click to expand...

Just wanted to raise a possible issue - I've always used 3 runs as a standard for PQ, as have many people before me, however we have had questions raised in the past by our customers (OEMs) about the statistical rationale for 3 PQ runs. Why 3? To be honest we've always squirmed round the answer before without tying it down properly.

Hope this helps & doesn't confuse the issue too much.

The heat sealer's only adjustible variable is temperature. the client is set at sealing 175C, there is no real justification.
IQ-perform necessary verifcations

OQ- seal at 3 diff temps ie 165 175 and 185. Use Peel Test as a FIO to determine nominal temp setting.

then write and perform a separate PQ

PQ perform 3 sets of seals at the nom setting decided at OQ. Test to Visual, Peel and BURST Test.

THere is no sterilization involved in the process.

Here's an interesting tidbit:

I just contacted a testing facility for package testing.

I was told if the product is not being sterilized or distributed sterile

then packaging testing is not "REQUIRED"....

Please Confirm...

If the device is not terminally sterilized (aka provided non-sterile), then there is no sterile barrier, and ISO 11607-1, -2 standards do not apply.

For my response above, I assumed the product was a terminally sterilized medical device. Bad assumption on my part I guess, but my answer still stands for medical device sterile barrier seals.

So this is a non-sterile medical device? Will it be sterilized before use at the hospital?

Assuming that the seal is intended to be a sterile barrier, would you be required to perform a CpK (variable) study or could you use an attribute study to prove compliance during PQ?