Packaging Integrity Tests
Packaging designs must have a microbiological barrier to maintain the sterility of a packaged product until use. Medical device manufacturers must prove that the packaging integrity of their products is unaffected by transportation validation, accelerated aging, real-time aging and to the point of specified shelf life.
Testing package integrity is essential for assessing the sterility and shelf life of a medical equipment or product. Package integrity testing includes tests such as visual, tensile, burst, sealing width as specified in the EN ISO 11607 standard series.
First of all, the relevant test request form is requested. According to the request form, tests are carried out and reported by our laboratory experts. The test report is shared with the customer. Our scope of service is as follows:
Packaging integrity tests
- Tensile Strength Test (ASTM F88- EN 868-5)
- Visual Test (ASTM F1886)
- Burst Test (ASTM F1140-ASTM F2054)
- Seal Width Test (EN 868-5)
- Leakage Test (ASTM F1929)
