DDL Inc.

DDL's full-service testing laboratory will provide the expertise to validate the efficacy of package systems for sterile medical devices. We are familiar with national and industry-specific standards. Our testing team is equipped with the full range of shock, vibration, product, package and material testing capability to meet packaging regulatory requirements.

Shelf-Life Studies / Accelerated Aging
Transportation / Distribution Simulation (ASTM D-4169, ISTA)
Package Integrity Testing (Dye Penetration, Bubble Leak)
Package Strength Testing (Peel Seal, Burst)
Microbial Barrier Testing (Aerosol, Talc, Immersion)
ISO 11607 Testing and Consulting

Sterile medical devices and packaging systems must perform consistently under variable sterilization, procedures, manufacturing conditions, and distribution hazards. In the device industry, it is generally accepted practice to evaluate the integrity of sterile medical device packages by subjecting a fully processed package to extremes in sterilization processes, performing a simulated distribution and handling stress test, and then evaluating the efficacy of the package for sterility maintenance through physical test methods or microbial barrier challenge. The test methods described offer a comprehensive and justifiable means of establishing package integrity and sterility.

DDL has been a leader and innovator in the package testing industry since 1990. We offer single source solutions to product and packaging engineers who are concerned that their products and packaging systems comply with domestic and international regulatory agency requirements.