How to use the Ampoule Breaking Tester
ISO 9187

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Testing the mechanical integrity of ampoules is critical to ensure safe drug delivery, especially for injectable pharmaceuticals. This article offers a detailed and professional guide on how to use the ampoule breaking tester for ampoules, in accordance with ISO 9187 standards. It also explains the role of ampoule strength testing and introduces the Break Force Tester Machine as an essential tool in pharmaceutical quality control. Whether you’re a QA technician, regulatory staff, or lab manager, this article provides actionable insights that directly support your compliance and product integrity goals.

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Understanding Ampoule Strength and Ampoule Break Force Testing

Ampoule strength refers to the resistance of the ampoule to external mechanical forces until it breaks at its designed breaking point. Accurate determination of this breaking force is essential to maintain product safety and usability. Improper break forces can lead to:

• Ampoule shattering during opening
• Contamination due to uncontrolled break
• Difficulty in opening by healthcare professionals

To evaluate this characteristic, the Break Force Tester Machine plays a vital role. It applies tensile force at a controlled speed and angle, allowing for reliable, reproducible measurements.

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Why Use a Ampoule Break Force Tester Machine?

A Break Force Tester Machine provides precise and standardized measurements of the breaking force required to separate the ampoule stem from its body. According to ISO 9187-1:2010, clause 6, this is the prescribed method to evaluate ampoule mechanical integrity. Key advantages include:

• Compliance with ISO 7500-1 for tensile testing machines
• Force range up to 200 N, with a test speed of 10 mm/min
• Minimal operator influence
• Ability to record clean break vs. fracture failure

Cell Instruments recommends the Тестер за счупване на ампули BST-01 as a reliable, standard-compliant solution for these tests.

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Step-by-Step: How to Use the Ampoule Breaking Tester

To ensure accurate and compliant test results, follow these detailed steps:

1. Prepare the Equipment

Ensure that the breaking tester meets ISO 7500-1 requirements:

• Calibrated for 200 N force range
• Controlled movement at 10 mm/min
• Fixture designed to apply force at 90° to the ampoule axis

Use a tester like the Cell Instruments BST-01, which comes with an ergonomic clamping setup and digital control for precision.

2. Sample Conditioning

According to ISO 9187-1, Section 6.3.2:

• Store ampoules at 20 ± 5 °C for at least 24 hours prior to testing.
• Randomly sample ampoules based on ISO 2859-1, Inspection Level S-4.

3. Setting the Test Parameters

Adjust the tester as follows:

• Set the force application to 10 mm/min
• Align the ampoule so that the predetermined breaking point (e.g., ceramic ring) is centered between the metal bars
• Force must be applied perpendicular to the ampoule axis

4. Perform the Test

• Secure the ampoule with the constriction between two metal jaws
• Start the machine; it will automatically apply tensile force until the ampoule breaks
• Record the breaking force value and observe the break quality (clean break vs. shattered)

5. Post-Test Evaluation

Compare the results against the force values specified in ISO 9187-1 Table 2. Additional validation may include:

• Checking for break location consistency
• Observing the cleanliness of the fracture
• Verifying break force uniformity across batches

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ISO 9187 Test Criteria for Ampoule Breaking Force

To comply with ISO 9187-1 and 9187-2, your breaking force results must meet the following:

• Consistent breaking at the designated point (centered ±1 mm)
• Resistance to sterilization: heating at 120 °C for 30 minutes, followed by immersion in 30 °C water
• Endurance through cleaning processes
• No exceeding optical retardation > 50 nm/mm post-annealing

Failure to meet these criteria may require adjusting the ampoule’s manufacturing process or breaking point design.

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Why Choose Cell Instruments Тестер за счупване на ампули BST-01?

If you’re evaluating how to use the breaking tester to meet ISO 9187 compliance, the Тестер за счупване на ампули BST-01 from Cell Instruments is a robust and user-friendly option. Key features:

• Meets ISO 7500-1 tensile test machine specs
• Optimized for ampoule neck fracture analysis
• Suitable for QA labs, R&D, and batch certification
• Optional data export and graph plotting functions

Using a reliable tester not only supports regulatory compliance but also boosts internal quality control confidence.

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Conclusion

Understanding how to use the breaking tester effectively ensures compliance with ISO 9187, protects product integrity, and safeguards end-user safety. From setting the correct test speed to interpreting break quality, every step matters. Incorporating a certified Ampoule Break Force Tester Machine into your workflow, such as the BST-01 by Cell Instruments, makes ampoule strength testing efficient and accurate.

By mastering these techniques, your lab or manufacturing facility can enhance quality assurance and uphold pharmaceutical packaging standards.

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Frequently Asked Questions

Q1: What is the ideal breaking force for ampoules according to ISO 9187?
A1: ISO 9187 specifies values based on ampoule type and size. Refer to ISO 9187-1 Table 2 for precise requirements.

Q2: Can other test speeds be used instead of 10 mm/min?
A2: Yes, ISO 9187 allows alternatives like 20 N/s if equivalent results are validated.

Q3: How often should the breaking tester be calibrated?
A3: It should be calibrated regularly based on usage frequency, and at least once annually per ISO 7500-1.

Q4: Can the BST-01 be used for plastic ampoules?
A4: It is optimized for glass ampoules, but adaptations for plastic may be available upon request.

Q5: What happens if the ampoule does not break cleanly?
A5: This may indicate manufacturing defects or improper annealing. Such samples should be rejected.