AQL for Sterile Product - Laminate Tubes

[kelman13]

We package our hemostatic powder in laminate tubes. We then send those tubes off to be sterilized.

We test the tube seals by submerging them in water and pulling vacuum. Bubbling from the tubes indicated leaks. What is the ACL for our tubes?

We have been told by our FDA consultant that because the products are sterile that the AQL is 0.0000. Zero defects.

-------- more info:
lot of 150k produced sterilize
QC indicated leaks
We then did a dry vac procedure and removed any tubes that were crushed after removing from vacuum = leaker. (validated prior to testing)
~47 boxes
Then QC retested and found 1 tube that had a small leak.
QA used the ANSI table on a per box basis, and then applied that heightened level of testing across the entire batch.
We had 1 leaking tube out of ~3700 tested. (<0.03 AQL)

Based on the guidance from our FDA consultant we are rejecting the lot.

Risk: If this lot was not sterilized (all 150k) & distributed there was be ZERO infections resulting from the normal use of the product. Nothing grows in the product.

If there was chance of causing serious injury as a result of the 0.03AQL I would be concerned, but there isn't.

On top of that in an MDD article online there is this line: The agency determined an AQL of 0.25% for invasive devices and an AQL of 0.65% for noninvasive devices.

How can our product be held to a higher AQC standard than invasive devices in the industry? (article is from 2004)

Thx for insight

 

[chris1price]

As with many issues, this comes down to risk. Are you certain that "If this lot was not sterilized (all 150k) & distributed there was be ZERO infections resulting from the normal use of the product. Nothing grows in the product." If this is the case, why are you sterilising it?

 

[shimonv]

We have been told by our FDA consultant that because the products are sterile that the AQL is 0.0000. Zero defects.

Hi kelman13,
It seems your consultant thinks that un-sterillized product is a critical defect, and you think otherwise... ?
I agree with chris1price that this comes down risk management. Someone must have thought it necessary to mitigate a certain hazard.
Another issue you are facing has to do with the labelling. You cannot release a product labeled as sterile where in fact it has defects in its packaging.


-Shimon

 

[kelman13]

So how can surgical glove be released with an AQL of 1.5? Based on holes in the gloves.

To me a hole in a surgical glove is a critical failure. How can't the FDA justify a 1.5 AQL for such a product.

Do you have a link to an FDA/ISO doc that state something to this effect.

"You cannot release a product labeled as sterile where in fact it has defects in its packaging."

 

[shimonv]

Look, to the best of my knowledge FDA does not dictate AQL levels per product category. They couldn't because of the variability between products, manufacturing processes, risk management, lot sizes etc.

They did spell out AQL of 1.5 for Surgeons' Gloves in 21 CFR 800. It would be fare to assume that if surgeons were not washing their hands before putting gloves the AQL would have been much lower.

Anyways, your consultant told you that your AQL should be zero for defective packaging. Somehow he sees it as a super critical issue because AQL=0 is a very tight parameters; extreme actually.

You must determine your AQL level based on risk assessment together with your consultant. It's not a black or white issues..

-Shimon

 

[Ronen E]

Just making a note that the AQL method was initially intended for commercial acceptance (incoming) testing purposes. It's not purely statistical and has economical factors in it. Unfortunately nowadays it is all too often taken out of its original context and applied as scripture.

I would argue that if performance risk is the driving force a robust statistical analysis should determine the sampling, the analysis method and the accept/reject criteria. Of course, if the application is such that there's a wide agreement or extremely convincing evidence that sterilization is not required, all this debate becomes meaningless.