Packaging Validation and Shelf Life Testing are essential components of your sterility assurance program. These tests ensure that sterility is maintained when a device is sealed in a package until expiration.

NAMSA, a leading packaging validation services CRO, We can assist you with all the testing associated with materials qualification, equipment qualification and process qualification.

Testing includes:

  • Accelerated Aging (ASTM F1980 and AAMI TIR 17)
  • Barrier Properties (ASTM F1608)
  • Biocompatability (ASTM F2475)
  • Bubble Emission (ASTM D3078)
  • Burst Testing (ASTM F1140)
  • Dye Penetration (ASTM F 1929)
  • Gross Leak Test (ASTM F2096)
  • Gurley Porosity
  • Packaging Conditioning
  • Real Time Aging
  • Seal Tensile Strength (ASTM F88)
  • Sampling Plans
  • Shipping Simulation (ASTM D4169, D7386 and ISTA or custom programs)
  • Vacuum Leak (ASTM D3078)
  • Visual Inspection (ASTM F1886)
  • Liquid Microbial Immersion