ISO 9187 Breaking Force Test
Ampoule 3 Point Bend Test
The ISO 9187 breaking force test is a vital procedure used in determining the force required to break an ampoule along a predefined breaking point, typically near the constriction of the ampoule. This test ensures the consistency and safety of glass ampoules used in pharmaceuticals, food products, and other industries where ampoules contain valuable or sensitive contents. Understanding the intricacies of this test is essential for manufacturers, quality assurance professionals, and regulatory bodies who rely on standardized testing to ensure product safety and quality.
What is the ISO 9187 Breaking Force Test?
The ISO 9187 ampoule breaking force test is standardized to assess the strength of ampoules, particularly focusing on the force required to separate the ampoule stem from the body without causing a fracture that might jeopardize the contents. This test ensures that ampoules designed for pharmaceutical, food, and chemical applications break cleanly at a predetermined location when subjected to specific forces, maintaining product integrity and preventing hazards during opening.
The breaking force test is also essential for validating that the ampoule’s predesignated breaking point—such as a ceramic ring or color pigment at the constriction—is properly positioned and durable enough to withstand normal handling, cleaning, and sterilization processes.
The Equipment Used in the ISO 9187 Ampoule Breaking Test
ISO 9187 Breaking Tester
A specialized ISO 9187 breaking tester is required for performing the breaking force test. The tester typically includes a tensile testing machine that adheres to ISO 7500-1 standards and is equipped with the following features:
- A testing speed of 10 mm/min
- A force measurement range of up to 200 N
- The ability to adjust the force application to accurately simulate the conditions under which the ampoule will be opened
- Detail about ISO 9187 Breaking Tester
Additionally, the breaking force tester should include components that ensure the ampoule is securely positioned during testing, such as metal bars set at a 90° angle to the ampoule’s axis. This configuration ensures that the force is imparted directly to the middle of the ampoule’s stem, causing it to break cleanly.
Procedure for the ISO 9187 Ampoule Breaking Test
Step 1: Sample Preparation and Conditioning
Before beginning the test, it is crucial to ensure the ampoules are in the right condition:
Sample Selection: A random sample selection based on ISO 2859-1 is recommended to ensure unbiased results.
Conditioning: Samples should be conditioned at a temperature of 20°C ± 5°C to replicate standard handling conditions.
Step 2: Setting up the Ampoule Breaking Test
Positioning the Ampoule: The ampoule is placed between the two metal bars in the ISO 9187 breaking tester. The distance between the bars is set to ensure that force is applied directly to the middle of the ampoule’s stem, perpendicular to its axis.
Step 3: Applying the Force
Using the tensile testing machine, force is applied to the ampoule. The breaking force is measured and recorded. If the force required to break the ampoule matches the specified requirements, the test is considered successful.
Step 4: Interpreting the Results
The results of the ISO 9187 breaking force test are evaluated based on the force required to rupture the ampoule at the predetermined breaking point.
Why is the ISO 9187 Breaking Force Test Important?
Quality Assurance in Pharmaceutical Packaging
In the pharmaceutical industry, ensuring that ampoules break at the right force is essential for protecting the contents of the ampoule, which may include valuable medicines or vaccines. By conducting ISO 9187 breaking force tests, manufacturers ensure that their products will not fail during handling or use.
Compliance with International Standards
The ISO 9187 breaking force test is aligned with international standards, such as those in ISO 9187-1 and ISO 9187-2. This compliance ensures that the products meet the necessary quality and safety requirements for use in various markets worldwide.
Improved Safety and Performance
A proper breaking force test helps to identify ampoules that might not perform as expected under typical conditions, reducing the risk of broken ampoules in transit or during product handling. This enhances overall safety for both manufacturers and end-users.
Ampoule 3 Point Bend Test and ISO 9187 Breaking Tester
The ampoule 3-point bend test is another method used in conjunction with the ISO 9187 breaking force test to evaluate the structural integrity of ampoules. This test is typically conducted to assess the ampoule’s ability to withstand mechanical stresses during storage and transport, providing additional insights into its performance characteristics.
Both tests play complementary roles in ensuring that the ampoule is durable, functional, and compliant with industry standards.
1. What is the primary purpose of the ISO 9187 breaking force test?
The primary purpose is to measure the force required to break an ampoule at a specific breaking point, ensuring the ampoule opens cleanly without damaging its contents.
2. What equipment is required for conducting the ISO 9187 breaking force test?
The test requires a tensile testing machine that meets ISO 7500-1 standards, capable of applying a force of up to 200 N at a testing speed of 10 mm/min.
3. What is the ideal temperature for conditioning ampoule samples before testing?
The ideal temperature is 20°C ± 5°C to simulate real-world storage and handling conditions.
4. How do the ISO 9187-1 and ISO 9187-2 standards differ in terms of breaking force requirements?
ISO 9187-2 specifies the allowable variations in the breaking force and tolerances for special cases, while ISO 9187-1 outlines the basic test procedure and equipment requirements.
5. Can the ISO 9187 breaking force test be modified for different types of ampoules?
Yes, the test can be adjusted for specific ampoule types by modifying factors such as the force application speed and force range, as long as the test results remain consistent.