Ampoule breaking force tester

1. Product Usage
Ampoule breaking force testerMainly used for accurately measuring the breaking force of various ampoules. In drug production and clinical use, breaking force is the core indicator for measuring the quality and safety of ampoules. 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 small, it is easy to cause accidental breakage during transportation or storage, leading to drug contamination and economic losses. By providing objective and accurate quantitative data, this instrument provides a scientific basis for manufacturers to adjust the scoring process and annealing parameters, and is a testing method for achieving closed-loop control of product quality and ensuring medication safety.

2. Industry compliance
The design and testing methods of this instrument strictly follow mandatory standards both domestically and internationally. It not only conforms toGB 2637-2016 AmpoulesNational standards are specifically designed to meet the national standards for pharmaceutical packaging materialsYBB00332002 Designed according to the requirements of the instrument for fracture force testing in China. Its accuracy (0.1N), testing speed (10mm/min), and force range (0-200N) are all strictly benchmarked against standards. At the same time, the instrument design also takes into account international standardsISO 9187-1 The requirements for ampoule fracture strength testing ensure that the test results are widely recognized in domestic drug registration, production licensing (GMP), quality sampling, and some international market access.

3. Core technical features

• Technical advantages and data reliabilityThe core adopts a high stability PLC industrial control system and a high-precision strain gauge force sensor to ensure stable testing process and high data repeatability. The force resolution reaches 0.1N, with an accuracy of ± 0.5%, far exceeding the basic compliance requirements. After the instrument testing is completed, the probe automatically resets to improve the efficiency of batch testing. Equipped with a built-in micro printer, it can instantly output numbered test reports, providing paper original records for the quality management system and meeting data traceability requirements.

• Convenience of operationEquipped with a 7-inch high-definition color touch screen (HMI), the Chinese graphical interface is intuitive and easy to understand. Users can easily set parameters, start tests with one click, and observe changes in force displacement curves in real-time. The instrument operation logic is clear, greatly reducing the training threshold and labor intensity for operators.

4. Scope/Scenario of Application

• Main applicationsSuitable for breaking force testing of color rings and easily breakable glass ampoules (including low borosilicate glass materials) with various specifications ranging from 1ml to 30ml.

• Applicable UnitPharmaceutical manufacturing enterprises (QC laboratories, online testing), manufacturers of pharmaceutical packaging materials such as medicinal glass ampoules, governments at all levels, third-party testing institutions (drug inspection institutes, quality inspection institutes), drug research and development institutions, and related higher education institutions.

• Extended ApplicationBased on its high-precision force measurement platform, customized special fixtures can be used to expand the application of other physical performance tests for pharmaceutical packaging, such as butyl rubber stopper puncture force, pre filled syringe pushing force, bottle cap opening force, etc., achieving multi-purpose use of one machine.

5. Implement standards
The instrument ensures that the testing complies with the following core standard specifications:

• YBB 00332002 "Low Borosilicate Glass Ampoule"

• GB/T 2637-2016 Ampoules

• ISO 9187-1:2010 Medical injection equipment - Part 1: Ampoules for injection

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

• Requirements of Good Manufacturing Practice (GMP) for Inspection Instruments

6. Technical parameters

• Test force: 200N (standard, customizable for higher range)

• Force measurement accuracy: ± 0.5%

• Force resolution: 0.1N

• Displacement resolution: 0.01mm

• Test speed range: 1~500 mm/min (stepless speed regulation, standard recommended speed 10mm/min)

• 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 data management

• Power supply: AC 220V ± 10%, 50Hz

• 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, refer to the standard (such asYBB00332002）Use the instrument ruler to accurately adjust the distance between the upper and lower fixtures in the corresponding table (e.g. set 1ml ampoule to 36mm). Set the standard testing speed on the touch screen (usually 10mm/min).

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,mustMake the notch face downwards and ensure that the force point of the upper pressure head is precisely aligned with the center of the notch.

3. execute testsStart testing. Apply pressure to the bottleneck by uniformly pressing down with the upper pressure head. The system automatically records the peak force value at the moment of fracture and displays the test curve in real time.

4. result processingThe screen directly displays the force value results and qualification judgment. Test reports can be printed in real-time. After testing, it is necessary to observe the cross-section and check its flatness to ensure that there are no sharp protrusions, cracks beyond the shoulders, or other non compliant phenomena.

8. After sales service
Jinan Xio Electromechanical provides comprehensive technical support: the instrument enjoys a one-year free warranty and lifelong maintenance. Provide detailed operational training (online/offline). We have a professional team that provides fast technical response 24/7. We deeply understand the needs of the pharmaceutical industry and can provideCustomization of special testing fixtures, automation of loading and unloading transformation, and integration with laboratory data management systemsWaiting for value-added services to help customers improve compliance and testing efficiency.

9. Frequently Asked Questions (FAQ)
Q1: Why is the instrument testing speed usually set at 10mm/min? Can it be adjusted?
A: 10mm/min is the testing speed specified in relevant domestic (YBB standard) and international (ISO 9187) standards. Following this speed is the foundation for ensuring comparability and compliance of test results. Of course, it can be adjusted. The instrument supports 1-500mm/min stepless speed regulation, which is mainly used for research or the development of special methods.

Q2: How does the data in the test report meet GMP's requirements for data integrity?
A: This instrument provides two methods: one is to output paper original records with a built-in micro printer, which has a number and timestamp; The second is to upload data to computer software through communication interfaces to achieve electronic storage, audit tracking, and tamper resistance. The combination of these two methods can effectively meet GMP's requirements for dataALCOA+The requirements of the principles of traceability, clarity, synchronization, originality, and accuracy.

Q3: We mainly produce export formulations. Can the data tested using this instrument be recognized by overseas customers or auditors?
A: Okay.Ampoule breaking force testerThe testing principle and key parameters (such as accuracy of 0.1N, speed of 10mm/min, and range of 200N) are strictly followedInternational standard ISO 9187-1The requirements. As long as the testing process is strictly carried out according to the standards and the instruments are calibrated regularly, the reports issued will beglobalAll within the scope have technical credibility and can meet the quality audit and international certification needs of overseas customers.