Medical Device Sterile Barrier Package Testing
Medical device packaging must maintain integrity over its claimed shelf-life under the storage conditions specified by the manufacturer. Real time aging programs provide the best data to ensure that packaging performance is maintained over the claimed shelf life, although due to time constraints in the product development process, QRA International also offers accelerated aging.
These 2 tests are run concurrently so as to provide
accelerated aging results validated by real time benchmarks.
Shelf Life Testing
QRA International performs
testing on products at specific intervals over real time storage to provide
accurate shelf life conclusions. However, the drive to get new products to the
market often means that accelerated aging tests are often run in conjunction
with real time aging to validate the product shelf life claims.
Accelerated Aging Testing (ASTM F 1980 and ISO 11607-1)
Our experts will tailor an accelerated aging test
program to your particular requirements. We perform benchmark testing on
products from the same batch before simulated aging to allow comparative
post-aging testing at specified time intervals; a testing process which
includes burst tests, dye penetration assessments, and peel strength testing.
Standards Complied by QRA International’s Labs
QRA International performs accelerated aging
according to ASTM F1980 “Standard Guide for Accelerated Aging of Sterile
Medical Device Packaging” and BS EN 868-8 “Packaging materials and systems for
medical devices which are to be sterilized.”
Additionally, QRA International's labs also test according to ISO 11607 - 1 so we comply with all these international standards, so that your certification is made so much easier.
For more information :
Asia
E : mark@qra.com.sg
Europe
E : reypereira@qra.com.sg
USA
E :tim@qra.com.sg
Australia
E :clifford@qra.com.sg
Website : https//www.qra.com.sg
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