Ampoule Three Point Bending Tester – ISO 9187

Introduction to Ampoule Break Strength Testing

Pharmaceutical ampoules are widely used for sterile drug delivery, requiring precise design and quality assurance to ensure safe, effective, and compliant usage. The ampoule three point bending tester plays a vital role in this process by evaluating the mechanical strength of the ampoule neck, ensuring that the force required to open it is within a predictable and safe range.

This instrument provides quantitative, repeatable data, helping pharmaceutical manufacturers meet the rigorous demands of ISO 9187, enhance product reliability, and protect both users and patients. As a leading solution provider, Cell Instruments Co., Ltd. offers advanced bending testers that align with industry needs.

Test Ampoule Strength According to ISO 9187

The ampoule three point bending tester is primarily designed to test ampoule breaking strength according to ISO 9187, the internationally recognized standard specifying mechanical tests for ampoules. ISO 9187 ensures that ampoules possess sufficient strength to resist accidental breakage during transportation and handling, while also being easy to open when required.

ISO 9187 specifically addresses:

Ampoule form and dimensions
Breaking force requirements
Fracture zone design
Test methods and conditions

Using ISO-compliant testing not only guarantees regulatory compliance, but also improves batch consistency and end-user safety, essential factors in modern pharmaceutical packaging.

Working Principle of the Ampoule Three Point Bending Tester

The ampoule three point bending tester works by placing an ampoule horizontally on two support points, with a third point (the plunger) applying vertical force at the ampoule’s neck. This setup simulates the mechanical stress experienced during manual breaking. The tester records the peak force at which the neck fractures.

Key steps include:

Fixture Installation: Choose a suitable metal support according to ampoule size (commonly 1 to 30 mL).
Sample Placement: Secure the ampoule on the supports.
Speed Adjustment: Set the test speed (e.g., 10 mm/min as standard, adjustable from 1–500 mm/min).
Fracture Initiation: The plunger descends until the ampoule neck breaks.
Data Capture: A high-precision load cell records maximum, minimum, and average breaking force.

This method allows manufacturers to monitor product quality, adjust materials or processes, and train users to safely handle ampoules in clinical settings.

Advanced Features of Cell Instruments’ Tester

The BST-01 Ampoule Breaking Tester from Cell Instruments delivers enhanced capabilities beyond basic force measurement. Designed to meet both ISO 9187 and GB 2637 standards, it supports R&D and high-throughput QC environments.

Highlighted features:

PLC Control & Touchscreen Interface: Easy operation with intelligent menus and programmable settings.
Interchangeable Fixtures: Test ampoules ranging from 1 to 30 mL.
Stepper Motor + Ball-Lead Screw Drive: Ensures accurate displacement and consistent speed.
Protective Safety Cover & Collection Tube: Prevents operator injury from glass shards.
Microprinter & RS-232 Interface: Supports documentation, reporting, and data export.
Adjustable Test Speeds & Auto Return Function: Improves efficiency and versatility.
Optional IQ/OQ/PQ Validation: Supports GMP compliance in regulated industries.

Benefits of Using an Ampoule Three Point Bending Tester

Incorporating this instrument into quality control protocols provides measurable benefits:

Improved Product Safety: Prevents injuries from unexpected shattering or sharp fragments.
Regulatory Assurance: Ensures full compliance with ISO 9187 and other global requirements.
Process Optimization: Reveals weak points in design, formulation, or manufacturing.
Cost Efficiency: Reduces waste, recalls, and batch rejections.
Enhanced User Experience: Ensures breakability is user-friendly without compromising sterility.

Why Choose Cell Instruments Co., Ltd.

With deep expertise in packaging material testing, pharmaceutical compliance, and custom test solutions, Cell Instruments is trusted by global quality teams. Our ampoule testers combine engineering precision, ease of use, and compliance-readiness, supporting industries such as:

Pharmaceuticals
Medical device packaging
Quality inspection labs
R&D facilities

Whether you’re testing ampoules, vials, or specialty glass containers, our instruments help you deliver safe, high-quality products with confidence.