Pharmacopoeia 5511 General Provisions Guide the Performance Testing Scheme for Lower Half Prefilled Syringes

In 2024, the National Pharmacopoeia Commission officially released the "5511 General Rules for Semi-Assembled Prefilled Syringes," marking another important step in China's pharmaceutical packaging materials sector. The 511 General mainly stipulates the production requirements and product quality requirements for semi-assembled prefilled syringes, applicable to semi-assembled prefilled syringes for pharmaceutical packaging with sterile supply in nest box packaging.

As a professional dedicated to medical device performance testing instruments for many years, based on the guidance in the 511 guidelines, I have summarized an overall inspection plan covering key targets such as Luer tapered joints, needles, and protective caps.

1.1 Inspection of Luer tapered joints

· 1 General Requirements: Jinan Zhongce Electromechanical Equipment Co., Ltd. provides a Luer connector compatibility tester, which strictly follows the Luer Tapered Joint Inspection Method for Pre-filled Syringes (General Rule 4040) to ensure the suitability and clinical safety of the Luer Tapered Connector.

· ‌ 2. Clamping Luer Connector Adapter Ring Pull-Out Force: Using the locking Luer connector pull-out force tester, this device can accurately measure the pull-out force of non-integrated locking Luer connector adapter rings, ensuring the clamping ring connection firmness is not less than 22N.

· ‌ 3. Locking Luer Connector Adapter Clamping Ring Torque Resistance: Using a locking Luer connector torsion resistance tester, this device applies torque to test the twisting resistance of the ring, ensuring compliance with enterprise standards or quality agreements.

1.2 Pinning Detection

· ‌ 1 Connection Firmness: Jinan Zhongce Electromechanical Equipment Co., Ltd. provides a needle connection firmness tester. This device simulates actual usage conditions and performs pull-out tests on the needle to ensure the needle and sleeve do not loosen or separate under a 22N load.

· 2. Puncture Patency: Using a pinhole patency tester, this device ensures unobstructed pinhole passage through pinhole testing or water pressure flow testing methods.

1.3 Helmet Inspection

· ‌ 1 Sealing performance of the cap and sleeve: Use a cap sealing tester, which tests according to the sealing inspection method for pre-filled syringe components (General Rule 4041, Method 1) to ensure good sealing between the cap and sleeve.

· ‌ 2. Pull-out force: Provides a cap pull-out tester, which can accurately measure the pull-out force of non-locking caps and sleeves, ensuring compliance with company standards or quality agreements.

· ‌ 3. Locking Luer semi-rigid tapered cap opening torque: Using the locking Luer cap opening torque tester, this device measures the opening torque to ensure the fit between the locking luer cap and the sleeve meets standards.

As a high-tech enterprise focused on the research, development, and manufacturing of laboratory analytical testing instruments, Zhongce Electromechanical has accumulated extensive experience and technical strength in the fields of medical device and pharmaceutical packaging material testing. In response to the requirements of the 5511 General Rules, Zhongce Electromechanical provides a variety of professional testing instruments and supports customization, striving to serve medical devices and relevant testing agencies to provide comprehensive and precise quality control solutions.