Instron‘s Landon Goldfarb talks through ISO 11040, a testing standard that addresses the design and functional properties of prefilled syringes, which is critical for ensuring that syringes work properly in a clinical setting. ISO 11040 evaluations are performed throughout the manufacturing process to minimise any chance of defective equipment leaving the factory as failure of any subcomponent can have a major impact on either the physician or patient: an improper seal can cause oxidation of the drug and affect the shelf life of the product, while structural damage to the syringe barrel could lead to device failures.
