Packaging Addition - Non-sterile barrier to protect the whole package

[deuce64]

Bit of an odd one here. Our Class II (USA) product is currently provided in a single sterile barrier that we have proven in shelf life/distribution out to 3 years. This product contains latex and as such, has seen some degradation issues over the years....though real time studies have proven 3 year shelf life. To further protect this device and lessen complaints we're considering the addition of a foil pouch like condoms use as a non-sterile barrier to protect the whole package. While we plan on performing ship/shake and baseline tests per iso11607, would anyone consider that the benefit of adding this pouch now, with limited shelf life data, would outweigh the risks of NOT adding it. i.e. don't wait for acc. aging data, but implement now to make a speedy improvement. Would love some thoughts. thanks
Note: foil added after eto degassing period (post sterilization)

 

[Ronen E]

Bit of an odd one here. Our Class II (USA) product is currently provided in a single sterile barrier that we have proven in shelf life/distribution out to 3 years. This product contains latex and as such, has seen some degradation issues over the years....though real time studies have proven 3 year shelf life. To further protect this device and lessen complaints we're considering the addition of a foil pouch like condoms use as a non-sterile barrier to protect the whole package. While we plan on performing ship/shake and baseline tests per iso11607, would anyone consider that the benefit of adding this pouch now, with limited shelf life data, would outweigh the risks of NOT adding it. i.e. don't wait for acc. aging data, but implement now to make a speedy improvement. Would love some thoughts. thanks

You'd have to repeat your sterilization validation to prove this outer package doesn't interfere.

 

[deuce64]

Sorry, point of clarification: foil pouch will be added after eto degassing period.

 

[somashekar]

To further protect this device and lessen complaints ......

What are the complaints like and what has been the root cause and how did you deduce that such a sterile barrier will indeed lessen the complaint...
You could be still overdoing the packaging in your new way with no real benefit.

 

[deuce64]

We have done testing to prove that the foil pouch has protective benefits. Truthfully, as with any latex package, true benefits are only realized in the long haul with realtime aging as accelerated aging is fraut with false negatives. Nonetheless, trying to accertain whther people would be comfortable with the added package that has yet to undergo full term acc aging

 

[v9991]

While it is welcome to upgrade the product (package); its little different set of expectation(diligence) for regulated industries;

1) How do you intend to prove that there are no side effects because of additional barrier. (because of additional barrier to moisture, latex could not retain some of desired characteristics; viz., brittle/fragile or smell etc., ) ; essentially how do you avoid from triggering new/different set of complaints.

2) Do you intend to update the labeling details, so as to indicate the set circumstances which customer to avoid(or take care of special precautions

accelerated and real time testing are all to address all such questions;

and current concept, is to assess the relevance of all such above questions through risk-assessment and take necessary call. (remember the emphasis on all such questions and assessment of impact & reasons and ur preparedness to address them; idea is to have list down all relevant-posibilities and take action or be prepared for each one of them.)

 

[pkost]

I would be extremely concerned that users may view the foil pouch as a sterile barrier. The products that I work with are commonly double pouched with the everything being sterile. The outer pouch is opened and the inner pouch dropped into the sterile field. In your case this would contaminate the sterile area.

My experience would suggest that you would also be unable to label the fact that the outer pouch is non sterile adequately.....People tend to assume from appearances, and avoid reading the label on something "so obvious"

[edit] to clarify this is biased towards the devices we manufacture, your product may be something completely different where something like what I describe is not an issue

 

[deuce64]

Continued thanks to those who are offering input.

I do see pkost's point about double sterile vs. single sterile confusion.Our product was initially sold in a single barrier, and the proposed pouch andIFU are pretty explicit. Additionally, our sales force intends to inservice thechange...if nothing else, its a reason to reach out to the customer. As you mayor may not know, latex is acted on by many environmental factors: Ozone, heat,humidity, oxygen. As such, our years of working with these products has provento us that accelerated aging cannot reliably replicate the affects of real timeaging - producing false negatives. This leads back to my original query to thisforum: ...if we put aside the factors related to actually proving that thepouch will work, and for the sake of this discussion say that 'it does work',i'm still wondering if those reading would look at the non-sterile package andsay, "ok, i know this is better for my product, but i don't have all theaging data on the pouch to say that it will withstand the test of time.However, even if the pouch were to fail at some point before shelf life ends,(and no longer be a environmental barrier), the product is no worse-off than itwas without it....and likely better than it was ...therefore, i will implement at risk until such aging data (on the pouch)becomes available." thanks again for thoughts.

 

[MIREGMGR]

The sterility issues (technical and communications) have been covered, and I agree with the comments.

In addition, per 11607 and good industry practice you should have done a distribution-cycle validation for your original sterile barrier packaging system (SBPS). Adding a second packaging material in contact with the SBPS raises obvious questions about vibration rubthrough of your SBPS during your distribution validation. If your project were happening here, we definitely would regard it as mandatory to revalidate the SBPS.

Given that requirement, for a product such as yours that is to be protected from UV, ozone and other factors, we would take the different approach of starting over with a hybrid-foil-materials SBPS.

(...) the product is no worse-off than itwas without it....and likely better than it was ...therefore, i will implement at risk (...)

I don't understand how such an approach would be regulatorily justified.

 

[deuce64]

MIREGMGR - good points re: 11607. Indeed, we are doing/have done that testing at baseline and have shown no detrimental effects. We also have done the performance testing to show the added benefit in a side-by-side ozone exposure test. As you are aware, there is an aging component of 11607-01 which essentially looks at the seal integrity out at the accelerated (and realtime) age interval. Since we are trying to impart fixes to an increased complaint trend - one that is not visible for months after corrective actions are put into affect - we are approaching the deficiency to the 11607 aging component by justifying that the risks of NOT implementing (i.e. higher user inconvenience rates) is outweighed by the potential benefits that would be acheived through having this pouch. Worst case is that the pouch doesn't provide a benefit, and we have just added labor and materials that are not useful. So that is the angle we're taking on 'regulatorily justifying' the change. To this I ask your's and other's thoughts.