Medical Packaging Validation
Tektronix offers a variety of tests to help you prove compliance with FDA regulations and the ISO 11607 standard, which specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
Package evaluation for the life science industry focuses roughly in three categories: distribution testing, package performance testing, and package integrity testing (accelerated aging).
Package Distribution Testing
Packaging for the life sciences industry must survive the many perils of the distribution process all while maintaining sterility.
- ASTM D4169 - Standard Performance Testing of Shipping Containers and Systems
- ASTM D7386 - Standard Performance Testing of Packages for Single-parcel Delivery
- ASTM D642 - Compression Testing of Shipping Containers
- ISTA Series 2 & Series 3 - Package Distribution Testing
- And More!
Package Performance Testing
Packaging for medical devices and supplies must be robust to maintain product reliability after distribution and storage so that they are ready for use on patients when needed.
- ASTM F1929 - Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F2096 - Detecting Leaks in Packaging Through Bubble Testing
- ASTM D3039 - Tensile Testing of Composite Materials
- ASTM F88 - Seal Strength Testing of Flexible Barrier Materials
- And More!
Package Integrity Testing (Accelerated Aging)
Medical device and supply manufacturers can use accelerated aging techniques to accelerate the effects of time on a package so that manufacturers can give products accurate shelf lives and expiration dates.
Accelerated aging uses temperature and humidity to stress packaging and simlate aging based on known reactivity relationships between the environmental conditions and the materials being testing. Accelerated aging speeds up your time-to-market and helps ensure product quality.