ASTM F88 Seal Strength of pouches - amount samples per pouch (discussion)

[LarsZ]

For years we have been testing our pouches using Seal Strength testing according to ASTM F88 and we always used multiple samples per pouch during packaging validation testing:
- the left seal, right seal, top seal which we all made by the manufacturer of the pouch (so 3 samples in total)
- the bottom seal which we made after placing our product in the seal (another 1 sample)

However, our testing partner now suggest that during packaging validation testing only
- one samples of the manufacturer seal (arbitrarily taken from the left seal, right seal or top seal)
- one sample of the bottom seal
My reaction was to disagree but looking into ASTM F88, ISO 11607-1 & ISO 11607-2 I could not find a requirement on this.

What is your experience with this? Did I miss the requirement somewhere? Or is it just a 'best practice'?

 

[Jean_B]

Perhaps
EN 868-5:2018 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods.

D.1:
"The seal strength of the pouch and reels before and after sterilization is determined by cutting at least one strip at 90° through each of the seals and pulling apart on a tensile testing machine meeting the requirements of ASTM F88/F88M.
NOTE For example, for preformed sterile barrier systems of type “chevron pouch” this would be four samples."

 

[planB]

In case you have a rationale and/or data at hand confirming the pre-sealed areas being all equivalent in terms of performance and stability, the suggestion of your testing partner could make sense. Alternatively, there is no reason why you could not continue with your current practice.

HTH,

 

[indubioush]

Why are you testing the supplier's seal as part of your process validation?

One company I worked for did only one sample per pouch. The other did three samples (left, center, right).

 

[chris1price]

I would test the manufacturers seals as part of incoming inspection of the batch of pouches. For process validation and in-process controls, only test the seal you have made. .

 

[LarsZ]

Perhaps
EN 868-5:2018 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods.

D.1:
"The seal strength of the pouch and reels before and after sterilization is determined by cutting at least one strip at 90° through each of the seals and pulling apart on a tensile testing machine meeting the requirements of ASTM F88/F88M.
NOTE For example, for preformed sterile barrier systems of type “chevron pouch” this would be four samples."

This is exactly the information is was searching for! I forgot to check this standard (although we do use it). Thank you for the quick and spot-on reply

 

[LarsZ]

Thank you all for your valuable input. Our rationale for performing these test are as follows:
- During validation of the forming of the pouch our supplier test the pouch & seals on compliance with ISO 11607-1 & ISO 11607-2
- During validation of our pouch sealing process we place products in pouches and seal the pouches and test our seal using Dye penetration testing and seal strength testing
- Now we know that our pouch and pouch sealing process is OK we perform accelerated aging and simulated transport upon which the product and its pouch is tested. During these test we again verify all the seals of the pouches; so the manufacturer seal as well as our seal to verify that the pouch can handle its intended shelf-life and transport.

Once these test are finished and production starts:
- we monitor the manufacturer seal during incoming goods inspections
- we monitor our sealing process using daily seal-checks and performed seal strength test during our periodic PQ validation

Thoughts and comments are always welcome ;-)

 

[Disadolly]

Hi
I realized that I missed the update of this standard and is busy with the technical file update. I am looking for a gap analysis of ASTM F88/F88M 2015 version vs 2021 update urgently. Does someone perhaps have this available to share with me please?

 

[planB]

[...] gap analysis of ASTM F88/F88M 2015 version vs 2021 update [...]

ASTM offers a redline version containing all changes.

HTH,