Luer Lock Rigid Tip Cap Unscrewing Torque

In the field of medical device manufacturing, the luer lock rigid tip cap unscrewing torque test plays a vital role in verifying the usability and safety of prefilled syringes. This critical test ensures that the rigid tip cap can be removed with appropriate torque, safeguarding both functionality and patient safety. Accurate testing is essential for compliance with international standards and for maintaining the high-quality production standards expected in the medical industry.

Importance of Luer Lock Rigid Tip Cap Testing

Proper execution of this test ensures:

Patient Safety: Ensuring that caps are neither too tight nor too loose protects patients from contamination or usability issues.
Regulatory Compliance: Meeting ISO 11040-4 standards is critical for market access and product acceptance.
Product Consistency: Testing supports consistent manufacturing processes, reducing defects and ensuring batch reliability.

Syringetest.com’s expertise in material testing and customized solutions ensures that syringe manufacturers can efficiently meet these stringent testing requirements, improving product quality and market competitiveness.

ISO 11040-4 and ISO 11040-4 Annex G5 Requirements

ISO 11040-4 and its Annex G5 outline detailed procedures and apparatus requirements for evaluating the luer lock rigid tip cap unscrewing torque. These guidelines ensure consistent and reliable testing across the industry.

According to ISO 11040-4 Annex G5, the purpose of this test is to assess the torque needed to unscrew the rigid tip cap from sterilized, ready-to-fill syringe subassemblies. The goal is to verify whether the cap removal torque falls within acceptable limits, neither too high (which could hinder usability) nor too low (which could compromise sterility).

The Annex specifies the need for:

A torque tester equipped with a rotation device.
A torque cell with 35 Ncm capacity and a resolution of 0.05 Ncm or better.
A rotation speed of 20 rotations per minute (rpm), adjustable based on agreement between the manufacturer and the customer.
Specialized fixtures like a tip cap gripper and syringe holder.

Test Procedure for Luer Lock Rigid Tip Cap Unscrewing Torque

Performing the luer lock rigid tip cap unscrewing torque test involves several precise steps:

Select sterilized subassembled syringes that match the production process. Proper sample handling ensures that the results accurately represent production quality.

Secure the syringe vertically into the syringe holder of the testing device.
Attach the adapter (tip cap gripper) onto the tip cap securely without applying pre-torque.
Set the torque cell to “zero” to ensure baseline accuracy.
Adjust the rotation device to 20 rpm or the agreed speed.

Initiate rotation either clockwise or counterclockwise, depending on system requirements.
Maintain a consistent rotation until the tip cap starts to unscrew.
Record the peak torque applied at the moment the cap begins to move.

It is essential to ensure a high sampling rate during testing. Annex G5 recommends a 500 Hz sampling rate for tests that require peak torque measurements, enhancing data accuracy.

After completing the test, document the following:

Maximum torque achieved (in Ncm).
Rotation speed used during testing.
Number of samples tested and the number of samples passing or failing according to specifications.
Any deviations, anomalies, or observations noted during testing.

Why Choose Syringetest.com?

The luer lock rigid tip cap unscrewing torque test, as defined by ISO 11040-4 Annex G5, is essential for maintaining syringe quality and ensuring compliance with global standards. With the right equipment and correct test procedures, manufacturers can confidently validate the usability of their syringe products. Trust Syringetest.com to deliver precision testing solutions tailored to your needs, helping you uphold the highest standards of safety and quality.