Page 14 - Assurance of Sterility for Sensitive Combination Products and Materials

4 Assurance of sterility for sensitive combination products and materials

might include both traditional trays and pouches for medical devices, as
well as traditional containers/closures used for biologics or pharmaceuticals.
One of the major challenges for combination products is how to achieve
the sterile label claim. This challenge dictates the choice of the process used
to assure sterility, and the level of manufacturing controls needed for pro-
duction. This challenge also has resulted in the opportunity to not only
reevaluate the traditional SAL but also consider the applicability and risk of
alternate SALs. Navigating this challenge has required that manufacturers
as well as regulators collaborate on how to achieve the sterile label claim.
Combination products and the associated regulatory aspects are dynamic
topics that continue to evolve driven by the new types of products that
will be needed for the future. This book will help equip sterility assurance
professionals to address new opportunities in order to ensure that patients
receive the optimal products with optimal risk-based sterilization solutions.