Post-filling Steam/Radiation Sterilization (for diluent or small molecule)

In 2015, SMP completed the process validation of the 6 mL vial. Shelf-life stability studies were conducted with 6 mL vials manufactured from the validated process. The shelf-life stability studies included both an empty container and a filled container shelf-life. The data from the shelf-life studies show that the SMP tri-layer coated 6 mL vials are stable throughout the shelf life. Technical Bulletin Series 2017-010