In July 2024, the National Pharmacopoeia Commission released the "4040 Pre filled Syringe Ruhr Cone Joint Inspection Method - Third Public Draft". This standard will be reflected in the pharmaceutical packaging materials section of the 2025 edition of the Chinese Pharmacopoeia. In the 2015 version of YBB drug packaging material standard YBB00112004-2015 "Pre filled Syringe Assembly (with Injection Needle)", there is actually no introduction to the Ruhr connector, only the requirements for syringes with needles are included in the standard. As there are more and more syringe products without needles on the market, and the products that match with injection needles require Ruhr cone connectors, in order to meet market development needs, the National Pharmacopoeia Commission has supplemented the Ruhr cone connector inspection method. Also referred to ISO 11040-4:2015 、ISO 11040-6:2019 、ISO 80369-20：2015、YY/T 0916.20-2019 Small aperture connectors for liquids and gases - Part 20: General test methods, ISO 0369-1:2018, YY/T 0916.1-2021 Small aperture connectors for liquids and gases - Part 1: General requirements, YY/T 0916.1-2014 Small aperture connectors for liquids and gases - Part 1: General requirements, ISO 80369-7:2021, GB/T 1962.1-2015 Syringes and injection needles -6% (Ruhr) cone fittings - Part 1: General requirements, GB/T 1962.2-2001 Syringes and injection needles -6% (Ruhr) cone fittings - Part 2: Locking fittings. Because it is a new standard, many of its provisions are newly added. Sanquan Zhongshi has drafted JJF (Jing) 139-2024 "Calibration Specification for Ruhr Cone Joint Performance Tester", which provides a deeper understanding of the requirements and calibration of the instrument.

We have sorted out the standard requirements and explained them here in conjunction with our own instrument research and application:

The "4040 Pre filled Syringe Ruhr Cone Joint Inspection Method" standard specifies five testing items: positive pressure liquid leakage test, stress cracking test, anti axial load separation test, anti twist torque separation test (only applicable to Ruhr locking cone joints), and anti overload (sliding wire) test (only applicable to Ruhr locking cone joints). It should be noted that due to the different methods used for locking and non locking joints during use, there are also differences in testing items. In addition, Sanquan Zhongshi reminds that it is necessary to use matching testing fixtures for professional testing of various performance tests of Ruhr cone joints. Inappropriate fixtures may rotate or move during the testing process. Even situations where alignment cannot be achieved will ultimately have a significant impact on the outcome.

In this context, the RJT-03S Luer Cone Connector Comprehensive Tester is a testing device designed specifically for locking and non locking Luer connectors used in medical devices. It has multiple independent testing modes such as leak testing, leak testing, separation force testing, stress cracking testing, unscrewing torque testing, anti slip wire testing, etc., which can comprehensively evaluate the performance of the Ruhr connector. The Ruhr cone joint comprehensive tester is widely used in medical device manufacturers, testing institutions, and other units, providing strong technical support to ensure the quality and safety of medical devices.

It is worth mentioning that all testing items of the "4040 Pre filled Syringe Ruhr Cone Joint Inspection Method" involve axial force and torque, and some items involve liquid pressure. In fact, pneumatic pressure is also used in ordinary disposable syringes. This comprehensive tester is equipped with weighing (force) sensors, torque sensors, and pressure sensors, which can accurately measure axial force and torque, as well as liquid and gas pressure. It is an integrated instrument that can complete all specified testing items at once, and needs to be calibrated according to the JJF (Jing) 139-2024 "Ruhr Cone Joint Performance Tester Calibration Specification" drafted by Sanquan Zhongshi to ensure the accuracy and reliability of test results. It should be said that it is a relatively complex specialized instrument in packaging instruments.

In summary, the RJT-03S Ruhr Cone Joint Comprehensive Tester is not only a positive response to the "4040 Pre filled Syringe Ruhr Cone Joint Inspection Method" standard, but also an important step taken by the pharmaceutical packaging industry to ensure product quality and safety. The application of this Jinan Sanquan Zhongshi experimental instrument can greatly improve the testing efficiency and accuracy of Ruhr connectors, providing strong guarantees for the safety and reliability of pharmaceutical packaging materials.