In the pharmaceutical and medical packaging industry, finger flange breakage force is a critical performance indicator for ensuring the structural reliability of syringe barrels. This parameter, defined and standardized in ISO 11040-4 Annex C1, helps manufacturers and quality assurance professionals assess whether the syringe flange can withstand mechanical stress during handling and injection.
Understanding this measurement and its standard testing method is vital for professionals involved in syringe testing, especially for sterile subassembled syringes intended for injectable solutions.
The finger flange breakage force refers to the maximum mechanical force the flange of a syringe can withstand before failure. This value indicates the syringe’s robustness, especially when users apply pressure during injection or when automated filling systems grip the syringe.
An insufficient breakage force can result in flange cracks or complete failure, posing a safety hazard. Therefore, maintaining consistent quality across batches is non-negotiable in medical device manufacturing.
The ISO 11040-4 Annex C1 outlines the test method for evaluating flange breakage resistance. The procedure ensures accurate, repeatable results, making it the gold standard in syringe performance testing.
To determine the flange breakage resistance by applying a downward force onto the syringe barrel using specialized equipment. This test evaluates both the glass barrel strength and its compatibility with the rest of the syringe design.
To perform the test as specified in ISO 11040-4 testing, follow these steps:
Avoid shocking or mishandling syringe barrels before testing. Inspect the holder and pin for wear.
The peak force observed before flange failure is recorded as the finger flange breakage force. ISO 11040-4 Annex C1 specifies that this value, along with test speed and sample count, should be reported in the final documentation.
Accurate flange breakage force testing requires high-performance instruments. At Syringetest.com, we offer advanced tensile and compression testers tailored for syringe testing, fully compliant with ISO 11040-4. Our systems are equipped with precision load cells, adjustable speeds, and intuitive software for real-time data visualization and export.
We also offer custom syringe holders and automation integration, helping streamline testing in high-throughput production environments.
