Leading to competitiveness through innovation in medical devices, biomaterials, and processes.

Testing

Biomaterials & medical devices analysis
and mechanical testing

Products and Packaging Validation

Packaging and stability validation

Accelerated aging tests (ASTM F1980-07) and requirements for materials, sterile barrier systems and packaging systems (NF EN ISO 11607 -09).

ASTM F1980 is a guide that provides information to develop accelerated aging protocols in order to rapidly determine the effects, if any, of time and environment on the sterile integrity of packaging and the physical properties of their packaging material components.

A mathematical equation gives equivalence between accelerated aging time and natural aging.

After subjecting packaging to aging tests, physical properties and integrity are evaluated according to NF EN ISO 11607 standard.

For the packaging validation, NF EN ISO 11607 standard defines test methods to verify the performance of packaging.

StandardsAppliance
ASTM F1929Standard test method to detect seal leaks in porous medical packagingsterile barrier system with porous material – Tyvek® for ex.
ASTM F1886Test Method to determine integrity of Seals for Flexible Packaging by Visual InspectionAny type of sterile barrier systems
ASTM D 3078Standard test method to detect leaks in flexible packaging by bubble emission.sterile barrier system with PA/PE film or multilayers films with aluminum foil
NF EN 868-5Sealable pouches and reels of porous materials and plastic film – Construction — Requirements and test methods.
Appendix D : tensile strength of sealing.
Appendix E : Manual peeling of sealing.
Any type of sterile barrier systems

These tests are conducted to determine :

Conformity of packaging with medical devices performances of new manufacturing process for medical packaging (QO and QP validation) and expiry dates of packaging for medical devices.