The quality of drug packaging materials is directly related to drug safety and stability. Ampoules, as an important primary packaging for injectable drugs, have breaking force performance, which is one of the key indicators affecting clinical safety. According to the mandatory national standard GB/T2637-2016 "Ampoules", ampoules must have appropriate breaking force, which can ensure the integrity during transportation and storage, and can be easily and safely opened by medical staff or patients during clinical use.

The Importance of Ampoule Breaking Force Testing

The breaking force test is the core test for evaluating the folding performance of ampoules. Excessive force can lead to difficulty in breaking open, which may cause injuries to the hands of medical staff or irregular rupture of ampoules, resulting in glass shards contaminating the medication; If the force value is too small, it may break during transportation or handling due to accidental force, resulting in drug leakage, contamination, and scrap. Therefore, strictly controlling the breaking force within the standard range is an important step in the quality control process of pharmaceutical companies.

National standard GB/T2637-2016 for ampoules of different sizes ranging from 1ml to 30mlThe minimum and maximum values of the breaking forceandTest bracket distanceClear regulations have been made. For example, for small-sized ampoules ranging from 1ml to 5ml, the distance between the supports is set to 36mm (18+18), and the breaking force should be controlled between 30N and 80N; For larger sizes ranging from 10ml to 30ml, the support distance is 60mm (22+38), and the range of breaking force is relaxed to 30N to 100N. These precise parameters are the fundamental basis for laboratory compliance testing.

In depth interpretation of the fracture force test method in GB/T2637-2016 standard

Article 5.4 of the standard provides a detailed explanation of the testing principle, instrument requirements, and testing steps for fracture force, providing a rigorous operational framework for testing work.

Test PrincipleRelatively intuitive: that is, to determine the force required to separate the bottleneck of the ampoule from the bottle body.Instrument requirementsThe specific requirements stipulate that the test speed should be 10mm/min, the measurement range should not be less than 200N, and the minimum resolution should not be less than 0.1N. These requirements ensure the accuracy and comparability of the test data.

Test stepsIt is the key to execution. Firstly, it is necessary to set the distance between two supporting metal brackets according to the specifications and dimensions specified in Table 3 of the standard. The ampoule is placed on a bracket, ensuring that the center axis of the force application device is at a 90 degree angle to the center axis of the ampoule. Then, a uniform force is applied until it breaks, and the instrument automatically records the peak force value as the breaking force.Standard specifically statesFor point scored ampoules, the force applying component must be accurately positioned in the center of the score (with the score facing downwards), otherwise it will result in significantly larger test results and lead to misjudgment.

After completing the force value test, the standard also requires conductingAssessment of cross-sectional flatnessAfter imitating the actual hand bending method to break another set of samples, a measuring tool with an accuracy of 0.01mm needs to be used to check whether there are protrusions or notches on the cross-section, and measure the distance from it to the bottom of the bottle. The difference between the two should not exceed 3mm, and there should be no cracks longer than the shoulder on the cross-section. This step visually evaluates the safety of ampoule breakage and prevents the generation of glass shards.

Choose a professionalAmpoule breaking force testerKey elements of

To meet the strict requirements of GB/T2637-2016, a high-performance and high-precision specialized testing equipment is crucial. idealAmpoule breaking force testerShould possess the following core characteristics:

• High precision sensors and measurement and control systemsThe instrument should be equipped with a high-resolution force sensor (with a resolution of at least 0.1N) and a stable measurement and control system to ensure accurate and repeatable force measurement across the entire range. This is the foundation for obtaining reliable data.

• Test fixtures that meet the standardsThe instrument should provide standard test brackets and be able to accurately and conveniently adjust the bracket distance (such as 36mm and 60mm) to meet the testing needs of different specifications of ampoules. The fixture design should be able to firmly hold the ampoule and prevent slipping or deviation during the testing process.

• Intelligent operation and data analysis softwareModern testers are usually equipped with touch screens and specialized software, which can preset test parameters (such as speed 10mm/min), automatically record and calculate test results, determine whether the force value is within the set upper and lower limits, and generate clear test reports, greatly improving detection efficiency and standardization level.

• Durable and sturdy mechanical structureA stable and reliable mechanical structure is the physical foundation for ensuring a smooth testing process and long-term data stability.

Frequently Asked Questions (Q&A)

Q1：Ampoule breaking force testerDo you need regular calibration? How to proceed?
A1：Yes, to ensure the accuracy and traceability of test results, the instrument must be calibrated regularly. It is recommended to perform calibration by a third-party metrology institution at least once a year based on the frequency of use. Calibration is usually based on relevant metrological verification regulations such as JJG (force value) to verify key indicators such as force value indication error, repeatability, and resolution of the instrument.

Q2: Can the same tester test all specifications of ampoules?
A2：Sure, but the testing fixture needs to be replaced or adjusted according to the requirements of standard GB/T2637-2016. The professional testing instrument will be equipped with rapidly replaceable fixture components that can cover all standard specifications from 1ml to 30ml. Simply set the corresponding bracket distance correctly according to the standard regulations before testing.

Q3: In the test, if the breaking force value of the ampoule is qualified, but the cross-section is uneven and has cracks, is it considered qualified?
A3：According to the GB/T2637-2016 standard, this is not qualified. According to standard 4.4.2, the fracture surface should be flat, with a difference of ≤ 3mm between the protrusion and the notch, and no cracks exceeding the shoulder. The qualified force value only meets the requirements of Article 4.4.1.The flatness of the cross-section is an independent and equally important assessment indicatorBoth must be met simultaneously in order for the fracture performance of this batch of products to meet national standards.

Q4: Can similar testers be used for mechanical testing of other drug packaging besides ampoules?
A4：Okay. The core mechanical testing platform can be widely used for testing other physical properties of pharmaceutical packaging materials by replacing different professional fixtures. For example, the opening force of penicillin bottles, the tearing force of eye drops bottles, the peeling strength of blister packaging, the torque of ointment caps, and the opening force of various bottle caps. This reflects the multifunctionality and scalability value of the device.

Q5: When purchasing a fracture force tester, besides the equipment itself, what other services should be considered from the supplier?
A5：Special attention should be paid to suppliersTechnical support and service capabilitiesIncluding: whether professional installation training, operation and maintenance guidance are provided; Whether it has the ability to develop methods according to enterprise standards; Can you provide long-term stable spare parts supply and technical support; And as mentioned earlier, do you have the capability to meet future non-standard or automation needsCustomized solution capabilityThese 'soft power' are key guarantees for ensuring the long-term stable operation and continuous value of equipment.

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