Syringe Testing to ISO 11040

ISO 11040 is a testing standard that addresses the design and functional properties of prefilled syringes. ISO 11040 is used primarily within the pharmaceutical industry and is critical for ensuring that syringes work properly in a clinical setting. ISO 11040 evaluations are performed throughout the manufacturing process to minimize 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. Note: Labs that manufacture syringes must be in compliance with 21 CFR Part 11. 

Annex G.5 of ISO 11040 specifically assesses the removal torque of rigid tip caps used in conjunction with female luer lock connections. When used in conjunction with a torsion-enabled universal testing system, a cobot can be extremely beneficial for lab productivity - essentially functioning as a pick and place operation to reduce operator influence. The repeatability of automated specimen insertion is also ideal for improving device alignment, a significant contributor to data spread. Since prefilled syringes can come in a range of capacities, the sample racking can be customized to accommodate all potential device geometry, and the seamless integration with Bluehill Universal means test methods for new devices can be created quickly.