Break Force Tester Machine<\/strong> as an essential tool in pharmaceutical quality control. Whether you\u2019re a QA technician, regulatory staff, or lab manager, this article provides actionable insights that directly support your compliance and product integrity goals.<\/p>\n
\nUnderstanding Ampoule Strength and Ampoule Break Force Testing<\/h2>\n
Ampoule strength<\/strong> 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:<\/p>\n\n- Ampoule shattering during opening<\/li>\n
- Contamination due to uncontrolled break<\/li>\n
- Difficulty in opening by healthcare professionals<\/li>\n<\/ul>\n
To evaluate this characteristic, the Break Force Tester Machine<\/strong> plays a vital role. It applies tensile force at a controlled speed and angle, allowing for reliable, reproducible measurements.<\/p>\n
\nWhy Use a Ampoule Break Force Tester Machine?<\/h2>\n
\u0410 Break Force Tester Machine<\/strong> provides precise and standardized measurements of the breaking force required to separate the ampoule stem from its body. According to ISO 9187-1:2010<\/strong>, clause 6, this is the prescribed method to evaluate ampoule mechanical integrity. Key advantages include:<\/p>\n\n- \u0421\u043e\u0431\u043b\u044e\u0434\u0435\u043d\u0438\u0435 \u0418\u0421\u041e 7500-1<\/strong> for tensile testing machines<\/li>\n
- Force range up to 200 N, with a test speed of 10 mm\/min<\/li>\n
- Minimal operator influence<\/li>\n
- Ability to record clean break vs. fracture failure<\/li>\n<\/ul>\n
Cell Instruments recommends the BST-01 \u041f\u0440\u0438\u0431\u043e\u0440 \u0434\u043b\u044f \u0438\u0441\u043f\u044b\u0442\u0430\u043d\u0438\u044f \u0430\u043c\u043f\u0443\u043b \u043d\u0430 \u0440\u0430\u0437\u0440\u044b\u0432<\/strong> as a reliable, standard-compliant solution for these tests.<\/p>\n
\nStep-by-Step: How to Use the Ampoule Breaking Tester<\/h2>\n
To ensure accurate and compliant test results, follow these detailed steps:<\/p>\n
1. Prepare the Equipment<\/strong><\/h3>\nEnsure that the breaking tester meets ISO 7500-1 requirements:<\/p>\n
\n- Calibrated for 200 N force range<\/li>\n
- Controlled movement at 10 mm\/min<\/strong><\/li>\n
- Fixture designed to apply force at 90\u00b0<\/strong> to the ampoule axis<\/li>\n<\/ul>\n
Use a tester like the Cell Instruments BST-01<\/strong>, which comes with an ergonomic clamping setup and digital control for precision.<\/p>\n2. \u041e\u0431\u0440\u0430\u0437\u0446\u043e\u0432\u043e\u0435 \u043a\u043e\u043d\u0434\u0438\u0446\u0438\u043e\u043d\u0438\u0440\u043e\u0432\u0430\u043d\u0438\u0435<\/strong><\/h3>\n\u0421\u043e\u0433\u043b\u0430\u0441\u043d\u043e ISO 9187-1, Section 6.3.2<\/strong>:<\/p>\n\n- Store ampoules at 20 \u00b1 5 \u00b0C<\/strong> for at least 24 hours prior to testing.<\/li>\n
- Randomly sample ampoules based on ISO 2859-1, Inspection Level S-4<\/strong>.<\/li>\n<\/ul>\n
3. Setting the Test Parameters<\/strong><\/h3>\nAdjust the tester as follows:<\/p>\n
\n- Set the force application to 10 mm\/min<\/strong><\/li>\n
- Align the ampoule so that the predetermined breaking point<\/strong> (e.g., ceramic ring) is centered between the metal bars<\/li>\n
- Force must be applied perpendicular<\/strong> to the ampoule axis<\/li>\n<\/ul>\n
4. Perform the Test<\/strong><\/h3>\n\n- Secure the ampoule with the constriction between two metal jaws<\/li>\n
- Start the machine; it will automatically apply tensile force until the ampoule breaks<\/li>\n
- Record the breaking force value<\/strong> and observe the break quality (clean break vs. shattered)\n