For medical devices, packaging must act as a microbiological barrier to maintain sterility until the point of use. Manufacturers are required to demonstrate that their packaging integrity remains intact through transportation, accelerated and real-time aging, and up to the product's specified shelf life.
Package integrity testing plays a critical role in validating both the sterility and the shelf life of medical devices. In line with the EN ISO 11607 standards, our laboratory performs essential integrity tests, including visual, tensile, burst, and seal width tests, to verify the durability and performance of packaging under varied conditions.
For a quotation, please fill out the test request form and email it to info@nioreg.com.
Our scope of service is as follows:
- Tensile Strength Test (ASTM F88- EN 868-5)
- Visual Test (ASTM F1886)
- Burst Test (ASTM F1140-ASTM F2054)
- Seal Width Test (EN 868-5)
- Dye Penetration Test (ASTM F1929)
