Ampoule Break Force Testing
In pharmaceutical packaging, ampoules for injectables must meet strict mechanical strength and safety standards to prevent contamination and ensure user safety. The एम्पाउल ब्रेक बल परीक्षक is a precision device designed to measure the force required to break the neck of an ampoule, ensuring it performs according to आईएसओ 9187 मानक.
This test is critical to confirm that ampoules break cleanly at their designated point, avoiding glass shards and ensuring safe drug delivery. By using an ampoule break force tester, manufacturers verify whether ampoules conform to mechanical performance requirements, especially the defined breaking force needed for consistent performance.
One excellent example is the BST-01 Ampoule Breaking Tester by सेल उपकरण, which enables reliable, repeatable testing in compliance with international standards.
Ampoules for Injectables: Regulatory Requirements and Quality Assurance
Ampoule Mechanical Strength Test According to ISO 9187
ISO 9187-1:2010 and ISO 9187-2 outline stringent quality requirements for ampoules for injectables, शामिल:
- Hydrolytic resistance of the glass
- Annealing quality to minimize residual stress
- Breaking force at the ampoule neck
- Position and thermal stability of the breaking point
Among these, the ampoule mechanical strength test—which evaluates the breaking force—is a critical parameter. According to ISO 9187, ampoules must exhibit a predetermined breaking point, such as a ceramic ring or scored neck, which enables a clean break under a defined force.
Testing this property is essential to avoid issues like glass shard contamination or incomplete breaking, both of which can compromise sterility or user safety.
Performing the Ampoule Breaking Force Test ISO 9187
उपकरण और सेटअप
The test must be conducted using a tensile testing machine in compliance with आईएसओ 7500-1. The machine should have:
- Test speed: 10 mm/min
- Force range: Up to 200 N
- Test fixture: Two metal bars set to apply force at 90° to the ampoule axis
The बीएसटी-01 एम्पुल ब्रेक फोर्स टेस्टर से सेल उपकरण is purpose-built for this task. It features programmable speed control, accurate force measurement, real-time data capture, and is adaptable to multiple ampoule sizes and shapes.
Sample Preparation and Conditions
- Sampling: Follow ISO 2859-1 (Inspection Level S-4) for random sampling
- Conditioning: Test samples should be at 20°C ± 5°C
- Alignment: Ensure force is applied at the ampoule’s breaking point centerline to avoid deviation in test results
Test Procedure Summary
- Place the ampoule in the test fixture with metal bars spaced as specified.
- Apply force using the machine at a controlled rate until the ampoule breaks.
- Record the breaking force (in Newtons).
- Evaluate whether the break was clean and consistent with आईएसओ 9187 specifications.
Choosing the Right Ampoule Break Force Testing
Manufacturers and laboratories seeking precision, compliance, and ease of use can rely on the BST-01 tester for ampoule mechanical strength evaluation.
Advantages include:
- Full compliance with आईएसओ 9187 testing conditions
- Automated control and programmable test parameters
- Real-time digital force display and logging
- इसके साथ संगतता various ampoule types (1ml–20ml)
- Reduces manual handling errors and operator variability
Whether used in R&D, production, or QA laboratories, the BST-01 supports high-throughput, standardized testing protocols, promoting both regulatory compliance और product quality assurance.
Contact Us Get Ampoule Break Force Testing Solution
A precise and reliable एम्पाउल ब्रेक बल परीक्षक is indispensable for manufacturers aiming to ensure the mechanical safety of ampoules for injectables. By following आईएसओ 9187 procedures and utilizing the advanced capabilities of instruments like the BST-01 from Cell Instruments, businesses can improve product consistency, reduce risks, and comply with global pharmaceutical packaging standards.
Whether you’re developing a new ampoule-based product or enhancing your QC protocols, investing in accurate ampoule mechanical strength testing is a strategic decision with lasting impact.
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