Engineering and Procedural Improvements to Avoid Cracks on Syringes During the Packaging Process

Abstract

One cracked syringe was found during the device functionality tests of a lot manufactured by XYZ biopharmaceutical company. A cracked syringe is categorized as a critical defect since it represents a risk to product quality and to patient safety. Strength testing and fracture analysis technology were used to determine the cause of the cracked syringe. It was found that the root cause of this defect was the design of the syringe-labeling equipment, which produced a lateral force on the syringe when passing through the outfeed vibratory rail. Labeler equipment modifications and packaging procedural improvements were implemented to eliminate the root cause and to avoid the breakage of syringes during the packaging process. Key Terms ⎯ AQL inspection, glide force, strength testing and fracture analysis, syringe-labeling.