Medical Device Packaging & Sterile Barrier Testing Laboratories
Medical device packaging must keep the device sterile until use. ISO 11607 sets requirements for sterile barrier systems; laboratories support it with seal strength (ASTM F88), integrity tests such as dye penetration and bubble leak, accelerated aging (ASTM F1980) alongside real-time aging, and distribution simulation (ASTM D4169 or ISTA procedures).
What does it measure?
- Seal strength
- Package integrity (leak detection)
- Performance after accelerated and real-time aging
- Performance after distribution simulation
- Temperature and humidity conditioning effects
When is it used?
- Qualifying a new sterile barrier system
- Supporting a labelled shelf life
- Material, sealer or supplier changes
- Investigating seal or package failures
Sample considerations
- Use packages sealed at validated process limits, including worst-case settings.
- Plan real-time aging in parallel with accelerated aging.
Laboratories with relevant capabilities
- Intertek (Lake Forest, CA) — Materials Testing, Metallurgical Analysis, Chemical Analysis
- Keystone Compliance (New Castle, PA) — Electrical & EMC, Wireless & RF, Environmental Testing
- Bureau Veritas Consumer Products Services (Buffalo, NY) — Chemical Analysis, Mechanical Testing, Microbiology
- Perritt Laboratories (Hightstown, NJ) — Package Testing, Microbiology Testing
- Impact Solutions (Livingston, Scotland) — Plastics Testing, Polymer Testing, Materials Testing
- Tri-Wall UK (Monmouth, Wales) — Package Testing, Transit Testing, Dangerous Goods Packaging Testing