Hi


Im writing a protocol for testing sterile peel pouches. In the past I have always used a lower limit for the peel force of 1 pound/inch width. However I can't find a reference that quotes this figure or another limit. I thought it was in ASTM F88-06, but can't find it. Does anyone know of a standard that gives such a limit?

Chris

Hi

Im writing a protocol for testing sterile peel pouches. In the past I have always used a lower limit for the peel force of 1 pound/inch width. However I can't find a reference that quotes this figure or another limit. I thought it was in ASTM F88-06, but can't find it. Does anyone know of a standard that gives such a limit?

Chris

I found this article in devicelink - Correlating Peel and Burst Tests for Sterile Medical Device Packages (http://www.devicelink.com/mddi/archive/03/01/002.html)

In the FDA website, there is a mention about Tensile Strength (Peel Test) - refer section 17 - Examination of Containers for Integrity (http://www.cfsan.fda.gov/~ebam/bam-22c.html)

It depends on how you are testing. In F-88-06 there is a description of the various test methods and then if you look on Table 4 (r and R Summary - Inch-Pound Units) it lists the 'Grand Average' of the various test methods. For example 'Supported 90°' has a Grand Average of 0.957 lbf/in which is probably where your value comes from. You might want to look at the table for the appropriate method (most likely unsupported) and take the value from there.

First post :)

Welcome to the cove, gholland :bigwave:

Its great to have you here :)

ISO11607 and EN868 have 1.5N/15mm seal

ISO11607 and EN868 have 1.5N/15mm seal

I've got ISO11607 (2006) and I'm not able to find that value. Can you give me a specific reference?

I'm actually looking for any vetted quantitative standard for package burst strength, but the best I can come up with is to calculate an implied burst pressure from the 1 lb/inch "rule of thumb" for a peel test, assuming that the FDA will buy it.

Any advice would be appreciated.
-J.

Try F-2054-00 - Standard Test Method for Burst Testing of Glexible Package Seals Using Internal Air Pressurization Within Restraining Plates

If you want to do unconstrained, try F1140-00 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications.


Both are available through ASTM.

Thanks very much. I have F1140, and it does list a couple of sample values from repeatability analysis (for an undefined package), but nowhere does it give a "good enough" value. I'm looking for a value above which it's reasonable to assume that the package is robust. All I'm finding are examples of actual test values. The only "rule of thumb" or minimum acceptable value I can find for any package testing is the 1 lb/in width value.

Thanks.
-J.