Ampoule Three Point Bend Test
ISO 9187-1
ISO 9187-1 is a critical international standard that defines the requirements for glass ampoules used for injectable medications. Ensuring these ampoules meet the required mechanical and chemical standards is essential for both patient safety and regulatory compliance. This standard outlines specifications for hydrolytic resistance, annealing quality, and most importantly, ampoule break force.
In pharmaceutical packaging and medical device manufacturing, understanding and applying ISO 9187-1 is vital to prevent risks associated with poor ampoule integrity—such as glass shard contamination or unpredictable breakage during drug administration. Proper testing, including the three point bending test and ampoule break force test, guarantees consistent quality and usability.
Key Requirements of ISO 9187-1
ISO 9187-1:2010 specifies three main performance criteria for ampoules:
- Hydrolytic Resistance: The internal surface of ampoules must meet ISO 4802 HC 1 glass classification to ensure chemical stability.
- Annealing Quality: Ampoules should not exhibit optical retardation over 50 nm per mm of glass, preventing internal stress that could affect durability.
- Breaking Force: Ampoules must break cleanly and predictably at a predefined weak point, typically marked by a ceramic ring or scored line.
Failure in any of these categories can result in product recalls, user injury, or compromised sterility—all avoidable with robust testing.
Ampoule Break Force Test: Ensuring Safe Opening
The ampoule break force test is a fundamental part of ISO 9187-1 compliance. This test evaluates the mechanical force required to snap the ampoule at its designated breaking point. The process involves using a tensile testing machine, like Cell Instruments’ BST-01, to measure and record the peak force.
Key parameters for this test include:
- Test Speed: Typically 10 mm/min
- Force Measurement Range: Up to 200 N
- Temperature Conditioning: 20 °C ± 5 °C before testing
- Setup: The ampoule is loaded between two metal bars; the force is applied perpendicular to its axis.
A consistent, predictable break confirms both manufacturing quality and user safety. Excessive or inconsistent break force may indicate poor annealing or structural issues.
Three Point Bending Test: Assessing Flexural Strength
Although not the primary method under ISO 9187-1, the three point bending test is used to analyze the mechanical flexibility and brittleness of ampoule materials, especially during R&D and failure analysis. It helps identify structural weaknesses and optimize material composition.
In this test, the ampoule is supported at two points while force is applied at the midpoint. The resulting data reveals how much stress the ampoule can handle before breaking. This information is useful when designing ampoules with optimal wall thickness and break profiles.
Why Use Cell Instruments' BST-01 for ISO 9187-1 Compliance?
To achieve repeatable and accurate ampoule break force test results, Cell Instruments offers the BST-01 Break Strength Tester. This instrument is purpose-built for ISO 9187-1 and GB 2637 compliance and features:
- High-Precision Load Cell: Captures exact break force values.
- Interchangeable Fixtures: Supports ampoules ranging from 1 to 30 mL.
- PLC Control & Touchscreen Interface: Streamlines operations with user-friendly automation.
- Adjustable Speed Settings: Customize test parameters for various ampoule types.
- Integrated Safety Features: Prevent injury from glass fragments.
- Optional Software & Printing: Enables data export and immediate report generation.
The BST-01 significantly enhances quality control workflows in pharmaceutical packaging, medical device production, and R&D environments by ensuring every ampoule meets stringent mechanical criteria.
Conclusion: ISO 9187-1 Compliance Is Non-Negotiable
Complying with ISO 9187-1 ensures that injectable ampoules are safe, functional, and consistent. By performing standardized tests like the ampoule break force test and the three point bending test, manufacturers can verify the reliability of their products and avoid critical quality failures.
With precision tools like the BST-01 from Cell Instruments, professionals can confidently meet ISO requirements and safeguard product integrity. Whether you’re in pharmaceutical production, regulatory testing, or R&D, accurate ampoule performance testing is essential to achieving compliance and protecting end users.