Glass ampoule breaking force tester

1. Product Usage
Glass ampoule breaking force testerSpecially designed for detecting the breaking force of low borosilicate glass ampoules. In the pharmaceutical industry, ampoules are the main packaging form for injectable drugs, and their breaking force directly affects the safety and convenience of clinical use. Excessive force may cause difficulty for medical staff to open, pose a risk of scratching, and affect medication efficiency; If the force value is too low, it may cause accidental breakage during drug production, transportation, or storage, leading to drug contamination and significant economic losses. This instrument provides accurate and reproducible quantitative data to help pharmaceutical companies and packaging factories scientifically adjust production processes (such as scratch depth and annealing process), ensuring that products meet the requirementsChinese PharmacopoeiaWhile meeting the mandatory requirements of drug packaging material standards, it also provides excellent clinical user experience, which is a key bridge connecting product quality control and terminal application safety.

2. Industry compliance
The design and testing methods of this instrument strictly follow the core standards of national drug packaging materials (drug packaging materials). It is not onlyGB 2637-2016 Ampoules A powerful tool for implementing national standards, specifically designed to meetYBB0033202-2015 "Low Borosilicate Glass Ampoule" Optimized according to industry standards. The instrument accuracy (0.1N), testing speed (10mm/min), and force range (0-200N) are strictly in accordance with the instrument requirements in Appendix 2 of the YBB standard "Determination Method for Breaking Force". The test reports obtained using this device are compliant for internal quality control, product registration and declaration in pharmaceutical production enterprises, as well as for supervision and sampling by drug regulatory departments (such as provincial and municipal food and drug inspection and research institutes) and GMP compliance inspections.

3. Core technical features

• Technical advantages and data reliabilityThe core of the instrument adopts a high stability PLC industrial control system, combined with imported high-precision strain type force sensors, to ensure real-time and accurate force value acquisition throughout the entire testing process. The resolution reaches 0.1N and the accuracy is ± 0.5%, far exceeding the standard basic requirements. The system has strong anti-interference ability and high long-term stability, providing unquestionable and reliable data support for process research and quality judgment. Equipped with a built-in micro printer, it can achieve real-time paper-based output and archiving of test results.

• Convenience of operationEquipped with a 7-inch high-definition color touch screen (HMI), the Chinese graphical operation interface is intuitive and friendly. Users can set test parameters, start tests, and observe force displacement curves in real-time with just one click. The instrument has the function of automatic high-speed return of the measuring head after the test is completed, coupled with a specialized ampoule fixture that can be quickly adjusted, greatly improving the efficiency of batch testing and reducing the labor intensity and training costs of operators.

4. Applicable scope/scenario

• Main applicationsSpecially designed for various specifications such as 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 25ml, 30ml, etcLow borosilicate glass ampoule(including color rings and easily breakable dot marks) breaking force test.

• Applicable UnitPharmaceutical manufacturers (QC laboratories, online testing points), manufacturers of low borosilicate glass ampoules and other pharmaceutical packaging materials, governments at all levels, third-party testing institutions (drug inspection institutes, quality inspection institutes), drug research and development institutions, and laboratories of relevant universities.

• Extended ApplicationBased on its high-precision force measurement platform, customized specialized fixtures (such as stretching fixtures, compression fixtures, etc.) can be used to expand the physical performance testing of other pharmaceutical packaging materials, such as butyl rubber stopper puncture force, pre filled syringe pushing force, blister packaging peeling force, etc., achieving diversified equipment functions.

5. Execution standards
The instrument ensures that the testing complies with the following core standards and specifications both domestically and internationally:

• YBB 00332002-2015 "Low Borosilicate Glass Ampoule"

• GB/T 2637-2016 Ampoules

• Guiding Principles of the Pharmacopoeia of the People's Republic of China

• General requirements for inspection instruments in Good Manufacturing Practice (GMP)

6. Technical parameters

• Test force: 0-200N (standard, higher range can be customized)

• Force measurement accuracy: ± 0.5%

• Force resolution: 0.1N

• Displacement resolution: 0.01mm

• Test speed range: 1~500 mm/min (stepless speed regulation)

• Speed accuracy: ± 1%

• Fixture support distance: adjustable, meeting the standard requirements of 36mm (for 1-5ml) and 60mm (for 10-30ml) critical spans

• Data output: Built in thermal micro printer; Standard RS232 communication interface, can be connected to computer software for advanced data management

• Power supply: AC 220V ± 10%, 50Hz, power<200W

• Dimensions: Approximately 450mm (length) x 350mm (width) x 600mm (height)

7. Operation process

1. Preparation and setupAccording to the specifications of the ampoule to be tested (e.g. 5ml or 20ml), refer toYBB00332002Standard Table 2: Accurately adjust the support distance between the upper and lower fixtures. Set the standard test speed (usually 10mm/min) and other parameters on the touch screen.

2. Install samplePlace the ampoule steadily on the V-shaped support seat of the lower fixture, ensuring that the axis of the bottle body is perpendicular to the direction of force application. For point scored ampoules, it is necessary to make the score face downwards and ensure that the force point of the upper pressure head is accurately aligned with the center position of the score.

3. execute testsStart the testing program, apply pressure to the neck of the ampoule bottle by uniformly pressing down with the upper pressure head. The system real-time draws the force value change curve and automatically records the peak breaking force at the moment of ampoule breakage.

4. result processingThe screen directly displays the force value results and the determination of whether they are qualified. Test reports with numbers, data, and time can be printed in real-time. Subsequently, visual or tool inspection can be performed on the cross-section to ensure that it is flat and free from cracks, notches, or sharp protrusions that exceed the standard.

8. After sales service
Jinan Xio Electromechanical promises to provide customers with comprehensive support: the equipment enjoys a one-year free warranty and lifelong maintenance and technical consultation. Provide on-site or remote operation and maintenance training. We have a professional technical team that can quickly respond to various application issues. At the same time, we deeply focus on the needs of the pharmaceutical industry and provide solutions fromCustomized special testing fixtures, automated loading and unloading transformation to a complete laboratory solutionOur value-added services help customers improve their testing efficiency and intelligence level.

9. Frequently Asked Questions (FAQ)
Q1: The instrument testing range is 0-200N. Can it cover the testing of all specifications of low borosilicate ampoules? The standard force requirement is 100N.
A: Can be covered. standardYBB00332002The prescribed breaking force value is 100N (for 20-30ml ampoules).Glass ampoule breaking force testerThe 200N range provides sufficient margin to ensure accuracy throughout the entire measurement range and safety for long-term use of the instrument, meeting the clear requirements of the standard for instruments with a measurement range of 0-200N.

Q2: How to ensure that the data tested by the instrument can be recognized by the drug regulatory inspection?
A: Firstly, the instrument itself needs to be regularly calibrated by a legal metrology institution and obtain a valid calibration certificate. Secondly, standards should be strictly followed throughout the entire testing process（YBB00332002）The prescribed steps include sample preparation, fixture distance setting, speed setting, etc. Finally, save the printed raw data records in a complete and clear manner. Following the above three points, the test data has traceability and compliance, and can be recognized by drug regulatory inspections.

Q3: What are the advantages of this specialized instrument compared to general-purpose material testing machines?
A: Specialization is the core advantage. It optimizes the fixtures for ampoule testing (avoiding sample rolling and precise positioning), pre sets standard testing methods, and simplifies the operation process extremely. Non professional inspectors can also quickly get started, avoiding the trouble of complex fixture adaptation and program editing required for general testing machines. At the same level of accuracy, its testing efficiency is higher, specifically designed for high-frequency testing in pharmaceutical QC laboratories.