Compliance work

Overall migration Sensory analysis

specific migration

Material analysis

Mechanical properties

permeation

PPWR/ Recycling

Seal strength, tensile test on strips (temperature range -40 to +120 °C)

Seal strength of machine-made sealings from pouches, sacks, packages, lidding films sealed on trays, cups etc. or sealing samples according DIN 55529 or ASTM F 88 (1 inch or 15 mm wide specimen), DIN EN 868 part 5 appendix D of medical packagings inclusive description of appearance of fracture.

Test Method Group: Mechanical properties

Norms:
  • DIN EN 868-5- D (2019-03) Packaging for terminally sterilized medical devices – Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods
  • DIN 55529 (2012-09) Packaging – Determining the sealed-seam strength of sealings made of flexible packaging material
  • ASTM F 88/ F 88M (2023) Standard Test Method for Seal Strength of Flexible Barrier Materials

Required Sample Amount: min ca. 300 mm sealing/ welded seam resp. 10 packages

Standard Tests

seal strength ASTM F 88 (15 mm specimen width)

Specific Norm: ASTM F 88/ F 88M

Sealed seam testing can be carried out either with 25.4 mm strip width and 300 mm/min test speed or with 15 mm strip width and 200 mm/min test speed. This is the second option.

seal strength DIN EN 868 part 5 appendix D (ASTM F 88) medical packages

Specific Norm: DIN EN 868-5- D

Packaging for terminally sterilized medical devices- Sealable pouches and reels of porous materials and plastic film construction- Requirements and test methods

seal strength DIN 55529 Polyolefin films

Specific Norm: DIN 55529

seal strength DIN 55529 laminated films, peel films

Specific Norm: DIN 55529

seal strength ASTM F 88 (1 inch specimen width)

Specific Norm: ASTM F88

Sealed seam testing can be carried out either with 25.4 mm strip width and 300 mm/min test speed or with 15 mm strip width and 200 mm/min test speed. This is the first option.