Ampoule Breakpoint Tester: Ensuring Quality in Ampoule Production

27 Mar.,2025

The Ampoule Breakpoint Tester is an advanced testing device designed for the precise measurement of the breakpoint force of ampoules. Manufactured in compliance with the DIN EN ISO 9187-1/2:2010 standards, it ensures that ampoules meet strict quality requirements during production, particularly before the filling process.

 

The Ampoule Breakpoint Tester is an advanced testing device designed for the precise measurement of the breakpoint force of ampoules. Manufactured in compliance with the DIN EN ISO 9187-1/2:2010 standards, it ensures that ampoules meet strict quality requirements during production, particularly before the filling process. This state-of-the-art instrument helps manufacturers maintain high-quality standards by reliably determining the point at which an ampoule breaks under force.


Operating Principle and Testing Process

The Ampoule Breakpoint Tester uses a stepper motor-driven jaw that applies increasing force to the ampoule in a controlled manner. The test begins when the jaw contacts the neck of the ampoule, and the force is gradually increased at a standard rate of 10 mm/min. The force continues to rise until the ampoule breaks, at which point the tester records and displays the maximum force. This result is then printed automatically on a connected printer, complete with date, time, serial number, and batch information.

The instrument features dual modes for force application: linear speed increase and linear force increase, allowing users to choose the mode that best fits their testing needs. Additionally, the Ampoule Breakpoint Tester comes with a programmable re-start function, enabling the tester to automatically begin a new test after a set time, speeding up testing sequences.


Key Features and Benefits

  • Dual Force Modes: Offers both linear speed increase and linear force increase for flexible testing.
  • Compliance with DIN EN ISO 9187-1/2:2010: Ensures accurate breakpoint testing for ampoules.
  • Automatic Re-start Function: Speeds up testing by automatically starting the next test after a preset time.
  • Programmable Printouts: Detailed force increase curve and testing results are printed, including batch and serial numbers.
  • Data Transfer via RS-232 Interface: For seamless integration with other systems and data handling.
  • Multi-Point Calibration: Ensures the accuracy and reliability of the instrument through rigorous calibration procedures.
  • Robust Build: Constructed from stainless steel, the tester meets GLP (Good Laboratory Practice) standards.

How the Cell Instruments Improves Ampoule Quality Control

The Ampoule Breakpoint Tester is essential for any production line where ampoules are used, especially in pharmaceutical and medical device industries. By testing the breakpoint force of empty ampoules, manufacturers can ensure that the ampoules will withstand the pressures and handling they encounter during filling, packaging, and shipping. This reduces the likelihood of breakage during downstream processes, improving both product safety and customer satisfaction.

In addition, the BST-01's compliance with DIN EN ISO 9187-1/2:2010 ensures that the testing process adheres to internationally recognized standards, helping manufacturers meet regulatory requirements with ease.


Technical Specifications

Test Range 0~200N (Or as required)
Speed 1~500mm/min 
Resolution 0.1N
Accuracy 0.5% F.S.
Power 110~ 220V 50/60Hz

Why Choose the Ampoule Breakpoint Tester?

The BST-01 is a robust, highly accurate instrument that plays a critical role in ensuring the quality of ampoules used in medical, pharmaceutical, and cosmetic products. By precisely measuring the breakpoint force, the BST-01 helps manufacturers detect potential weaknesses in ampoule production, ensuring only the highest quality products reach the market.

Invest in the BST-01 for Reliable, Accurate Testing Every Time.

Frequently Asked Questions (FAQ)

1. What is the primary function of the BST-01 Ampoule Breakpoint Tester?
The BST-01 is designed to measure the breakpoint force of ampoules during production, ensuring they meet the required standards for quality and safety.

2. How does the BST-01 ensure accurate results?
The BST-01 uses precise stepper motor-driven jaws and multiple-point calibration for consistent, accurate breakpoint testing.

3. Can the BST-01 test all sizes of ampoules?
Yes, the instrument is equipped with a standard jaw set that can test ampoules from 1 to 30ml, and additional jaw sets are available for specialized testing.

4. Is the BST-01 easy to operate?
Yes, the BST-01 features a user-friendly interface with numerical and functional keys, an LED display, and a programmable re-start function for efficient testing.

5. How are test results documented?
Test results are displayed on an LED screen and can be printed via a connected printer. The printout includes detailed information such as the force curve, test date, batch number, and more.

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