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.
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