Packaging and stability validation
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.
|ASTM F1929||Standard test method to detect seal leaks in porous medical packaging||sterile barrier system with porous material – Tyvek® for ex.|
|ASTM F1886||Test Method to determine integrity of Seals for Flexible Packaging by Visual Inspection||Any type of sterile barrier systems|
|ASTM D 3078||Standard 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 868-5||Sealable 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.