The Ampoule Break Force & Penetrability Tester is a precision-engineered instrument designed to measure the mechanical integrity of pharmaceutical ampoules. It accurately determines the force required to snap open the ampoule neck (Break Force) and evaluates the penetrability of hypodermic needles through the rubber/septum closures (Penetrability Test).
This high-accuracy tester ensures compliance with stringent pharmaceutical packing standards by delivering repeatable, traceable, and objective test results for quality control laboratories.
The instrument operates through a high-precision load cell coupled with a controlled-speed drive mechanism. The ampoule is held in a rugged, adjustable fixture, while a steadily increasing force is applied until the ampoule neck breaks. During penetrability testing, the needle is driven into the ampoule closure at a defined speed, and the instrument records the force required for smooth penetration.
The computerized model offers advanced graphical reporting, real-time data acquisition, and exportable testing records. It seamlessly connects with a PC, enabling trend analysis, batch-wise reporting, and integration with LIMS systems.
This machine is ideal for pharmaceutical manufacturers, QC labs, packaging development teams, and regulatory compliance testing.
Applications:
Tests Performed on One Instrument
• Ampoule Break Force Test
• Needle Penetrability Test
• Mechanical strength analysis of small glass containers
• Material validation for ampoule forming machines
Standards Compliance
• ISO 9187
• ISO 13926
• Pharmacopoeia Requirements (IP/BP/USP for break force & penetrability)
• Microprocessor-based control for precise force measurement
• High-accuracy load cell to detect small force variations
• Smooth motorized drive for uniform force application
• Digital display of break force and penetration force
• Over-travel & overload protection built into the system
• Rugged gripping fixtures designed specifically for slender glass ampoules
• High-strength needle penetration fixture for consistent plunging action
• Rapid screw mechanism synchronized with gear motor
• Peak Force, Tare, and Hold functionality
• Sturdy MS body with corrosion-resistant powder coating
• Low maintenance & long operational life
Optional Accessories
• Computerized Software Package
• Custom Ampoule Grips (small/large/bulbous neck)
• Interchangeable Needle Penetration Fixtures
• Validation & Calibration Kit (traceable to ISO 17025)
Computerized Software
• Real-time test monitoring
• Force vs Time / Force vs Displacement graphs
• Batchwise report generation
• Pass/Fail evaluation based on limit values
• Export reports in PDF/Excel formats
• Secure data storage & retrieval
• Email report facility
• Compatible with RS-232 interface
|
Parameter |
Specification |
|
Load Cell Capacity |
50 Kgf/ 500N |
|
Accuracy |
± 0.5% of full scale |
|
Display |
Digital LED Display with PC Connectivity |
|
Least Count / Resolution |
0.005 Kgf |
|
Test Speed |
variable 10–300 mm/min |
|
Test Modes |
Break Force / Penetration Force |
|
Fixtures |
Adjustable ampoule clamp, needle penetration fixture |
|
Power Supply |
220V AC, Single Phase, 50 Hz |
|
Load Units |
Kgf / N (selectable) |
|
Data Output |
RS-232 / USB (computer compatible) |
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