Seal Testing of Medical Device Packaging: Tyvek Lid Thermal-Sealed to Thermoform Tray Tyvek is a revolutionary protective material which has become standard in the medical device packaging industry. A thermoform tray is typically made of polycarbonate or PET formed to the shape of a medical device to create a protective package. A sterile seal is formed by pressing a flexible Tyvek cover over the thermoform tray. Tyvek provides a high degree of protection for medical devices and supplies due to its tough tear strength and puncture resistance. New and improved rigid medical packaging must always be regulated for seal quality and sterilization. Most often ASTM F88 and ISO 11607 are used as testing guidelines for measuring package quality. For both ASTM F88 and ISO 11607, it is best to conduct a 180 degree peel-back test. These tests involve taking a polycarbonate tray and testing multiple 1 inch wide seal sections between the flexible Tyvek and the lip of the tray using a TestResources Peel Test Machine. Tyvek test machines can be configured by TestResources applications engineers to meet the specific needs of the medical package testing process. Our product line includes a wide variety of equipment for package testing including test machines, test software, grips, test fixtures and sample preparation aids. Call today to speak directly with a TestResources applications engineer.
Applicable Testing Standards
- ISO 11607 Packaging for Sterilized Medical Devices
- ASTM F88 Seal Strength Testing Equipment for Flexible Barrier Materials
Recommended Test Machine
Forces up to 10 kN (2,250 lbf)
Low force tabletop systems
Modular series of five frame options with adjustable test space
Affordable testing option for tension, compression, bend, peel and much more
Forces up to 5 kN (1,125 lbf)
Low force tabletop systems
Tests at speeds up to 2,500 mm/min (100 in/min)
Best for high travel or high elongation test requirements
Recommended Testing Accessories
Rated to 220 N (50 lbf)
Maximum specimen thickness of 8 mm (0.31 in)
Wider model allows for specimens thicknesses up to 46 mm (1.8 in)
Cost effective option for low force testing
Rated to 500 N (112 lbf)
Maximum specimen thickness of 6 mm (0.23 in)
Pneumatic design allows for quick specimen setup
Consistant clamping force between tests
Rated to 100 N (22 lbf)
Maximum specimen thickness of 18 mm (0.71 in)
Pneumatic design allows for quick specimen setup
Consistant clamping force between tests
Rated to 1 kN (225 lbf)
Maximum specimen thicknesses from 10 mm to 50 mm (0.39 in. to 2.0 in.)
Simple design can be used for a multitude of tensile applications
Inexpensive and reliable
Standard sample widths of 0.50 in. and 1.00 in.
Other sample widths available upon request
Effective and simple to use
Blade replacement takes mere seconds
