ASTM F2054 specification for burst testing on sealed foil & laminate pouch

P

PaulT

I am trying to set a specifciation for burst testing (ASTM F2054-07) on a sealed foil and laminate pouch. I want to assure that it will not fail during expidited shipping in an air plane. I know that the pressure differential from sea level for 40000 ft is 12 psig. Any help on this would be greatly appreciated. :confused:

Thanks
 

harry

Trusted Information Resource
There's an article: ***DEAD LINK REMOVED*** Correlating Peel and Burst Tests for Sterile Medical Device Packages in this thread: Sterile Pouch Peel Force of 1 pound/inch width which contain some information that should be useful for you.

Testing Procedures. The pouches were conditioned at ASTM standard test conditions for 48 hours prior to testing. The following procedures were then performed.

A restrained burst test using an open package fixture was performed according to ASTM F1140-96 and ASTM F2054-00.10,11 Parameters under study were the flow index (1, 5, and 9) and plate separation (0.5 and 1.0 in.). The sample size used for each flow-index/plate-separation combination was 10 (n = 10). Therefore, a total of 60 pouches of each material combination were burst tested (3 flow values x 2 plate separations x 10 samples per flow-index/plate-separation combination). Power calculations were used to determine the sensitivity of the experiments when using a sample size of 10.9
 
Last edited by a moderator:
P

PaulT

Thank Harry for the additional information about 1.0 in-lbs for the ASTM F-88 peel test. I have used that number for the last 7 years and never knew the lineage. (min pdg std for J&J and MDT)
 

MSterling

Starting to get Involved
Thank Harry for the additional information about 1.0 in-lbs for the ASTM F-88 peel test. I have used that number for the last 7 years and never knew the lineage. (min pdg std for J&J and MDT)

Hi Paul, actually the units for F88 seal strength are pounds per inch (lb/in.), not inch-lbs. - common error.

Tribal knowledge has it that the 1.0 lb/in was generated by the coating supplier as a spec that they could reasonably guarantee. Nothing more than that. The actual source of a manufacturer (MDM, not the supplier or other external entity) spec. is whatever will withstand subsequent processing, e.g. sterilization, distribution simulation and the like. The min spec. can be whatever you wish as long as you have reasoned, defensible rationale that will sustain scrutiny.

If you have a light product (e.g. band-aid), it can be .25 lb/in. For something heavy and bulky, you'll need something stronger. But you have to defend your choice. Show your work, bring receipts.
 
Top Bottom