For a printer-friendly version, click here.

To access our Medical Device catalog of services, click here.

Physical Testing Services for Medical Device Packaging and Products 

Sterile medical devices and packaging systems must perform consistently under variable sterilization procedures, manufacturing conditions, and distribution hazards.  AppTec offers comprehensive testing services to help medical device manufacturers establish the functionality and safety of a package or product.  

PACKAGE VALIDATION SERVICES 

Shelf-Life Studies

     Environmental Conditioning

     Accelerated Aging (ASTM F 1980)

     Expiration Dating 

ISO 11607-01 Testing and Consulting 

Shipping/Distribution Simulation Testing (ASTM D4169) 

Package Strength & Integrity Testing

     Dye Penetration Leak  (ASTM F 1929)

     Seal Strength (ASTM F 88)

     Peel Adhesion (ASTM D 3330)

     Burst Creep (ASTM D 1140)

     Bubble Emission (ASTM F 2096)

     Bubble Emission (FPA-SPMC-005-98) 

Package Process Validations   

PRODUCT TESTING SERVICES 

ISO Product Performance & Safety Testing 

Microbial Barrier Performance Testing

Mechanical Tensile/Compression Strength Testing 

Materials & Assemblies Strength Testing 

Shock & Vibration Testing (Mil Std, ASTM, ISO, IEC, etc.)