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What is your Sterile Medical Device Pouch Peel Strength Spec?

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Some Related Topic Tags
astm f88 - seal strength of flexible barrier materials, astm f88 - test method for seal strength, peel force, peel testing, sterile packaging
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  Post Number #1  
Old 15th September 2018, 08:45 AM
d.conroy

 
 
Total Posts: 10
Question What is your Sterile Medical Device Pouch Peel Strength Spec?

I've started in a new company and they use a pouch peel strengths test spec of spec of 50N/15mm (50gf) or 70N/25mm (70gf). (Tested to ASTM F88).
Sterile medical devices, that use all kinds of sheet materials: Tyvek, coated paper, clear film and heavy PE.

All my experience is with the spec of 1.2N/15mm as stated in EN 868-5

I'm wondering is this acceptable of what do other companies use?

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  Post Number #2  
Old 17th September 2018, 04:20 AM
shimonv

 
 
Total Posts: 308
Re: What is your Sterile Medical Device Pouch Peel Strength Spec?

I've seen other companies use 1.2N/15mm. It is the minimum seal strength according to EN 868-5.

ASTM F88/F88M-15 is FDA recognized standard. If you are selling in the US you should consider its content.

-Shimon
  Post Number #3  
Old 18th September 2018, 04:04 AM
d.conroy

 
 
Total Posts: 10
Re: What is your Sterile Medical Device Pouch Peel Strength Spec?

Thanks shimonv,
Anyone else know their specification?
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