Testing of disposable sterile insulin syringes encompasses three major areas: physical properties, chemical properties, and biological properties. Physical property testing includes key indicators such as syringe scale accuracy, needle sharpness, syringe rigidity, piston sliding performance, syringe body seal, and residual fluid volume. Chemical property testing primarily focuses on parameters that may affect drug stability and biosafety, such as ethylene oxide residue, UV absorbance, heavy metal content, and pH.
Biological property testing includes biocompatibility evaluation items such as sterility testing, bacterial endotoxin testing, cytotoxicity testing, and skin sensitization testing. The testing scope covers the entire process from raw materials and components to the final assembled product, ensuring that the syringe does not introduce exogenous contamination during use and can accurately and safely deliver the specified dose of insulin.
