Ampoule Break Force Tester
- ISO 9187 Breaking Force Test
The Ampoule Break Force Tester is a crucial instrument used in the pharmaceutical industry to measure the strength required to break the neck of an ampoule. This test ensures the safety and reliability of ampoules, which are commonly used to store pharmaceuticals. By evaluating the break force, manufacturers can verify that the ampoules meet industry standards for safety and durability.
Understanding the Importance of Ampoule Break Force Testing
Needle penetrability test evaluates the ease with which a sharp object, typically a needle or stylus, can penetrate a sample. The force required for penetration is measured, providing data that can help manufacturers determine the material’s texture, hardness, and suitability for specific applications.
This test method is especially vital in industries like pharmaceuticals, where the consistency and quality of products such as rubber stoppers, seals, and soft capsules must meet stringent standards. Similarly, in packaging and food testing, the needle penetrability tester ensures that materials can withstand certain physical conditions without compromising quality.
How the Penetrability Tester Work?
Ampoules are sealed containers used to store pharmaceuticals and are designed to be easily broken for access to the medication inside. However, the break force of an ampoule’s neck is essential for several reasons. If the break force is too low, the ampoule may break too easily, posing a risk of contamination or injury. Conversely, if the break force is too high, it could make the ampoule difficult for users to open, compromising patient safety.
An Ampoule Break Force Tester quantifies the force needed to snap the neck of an ampoule, helping ensure that the product is both safe to use and properly sealed. This test is a key quality control step in the production process, helping to meet various international standards, including ISO 9187.
How the Ampoule Break Force Tester Works
The testing process for ampoule break force is relatively straightforward but highly precise. Here’s how it typically works:
- Sample Preparation: The ampoule is placed on a specially designed fixture that holds it in place during testing. The fixtures are available in various sizes, typically for 1ml, 2ml, 5ml, 10ml, and 20ml ampoules, to accommodate different ampoule types.
- Force Application: A pressing head, powered by a precision stepper motor, applies force to the ampoule neck. The speed of the force application can be adjusted, typically between 1 to 500 mm/min, to simulate different real-world conditions.
- Measurement: The break force is recorded using a high-precision load cell, which detects the exact moment the ampoule neck breaks. The test is performed under controlled conditions to ensure consistency and accuracy.
Data Output: The results are displayed on the integrated HMI touch screen and can be printed using the device’s dot matrix microprinter for documentation. Additionally, some models offer RS 232 connectivity for data analysis with specialized software.
Standards Governing Ampoule Break Force Testing
Ampoule break force testing is governed by several international standards to ensure consistency and reliability. One of the key standards is ISO 9187, which outlines the procedures and requirements for the break force of ampoules used in the pharmaceutical industry. Other relevant standards include GB 2637 and YBB00332002, which offer additional guidelines for ampoule testing.
ISO 9187 Breaking Force Test
The ISO 9187 series outlines critical requirements for testing the break force of ampoules, ensuring both the safety and integrity of pharmaceutical packaging. The test is designed to determine the force needed to cleanly break the ampoule neck at the designated breaking point.
Testing Procedure for Break Force - ISO 9187
ISO 9187 specifies a detailed procedure for testing the breaking force of ampoules:
- Test Principle: The purpose of the test is to determine the force needed to separate the ampoule’s neck from its body and to assess whether the break is clean and smooth. A clean break ensures ease of access to the contents without compromising the sterility or effectiveness of the pharmaceutical inside.
- Apparatus: The tensile testing machine used for this procedure must adhere to ISO 7500-1. The machine should be capable of applying force at a consistent speed of 10 mm/min, and it must have a force measuring range of up to 200 N. Alternative test procedures with a power increase rate of 20 N/s are permissible, provided they yield equivalent results.
- Sampling: Random sampling is recommended in accordance with ISO 2859-1, using inspection level S-4. The samples should be conditioned at a temperature of 20°C ± 5°C to simulate standard testing conditions.
- Procedure: The ampoule is positioned between metal bars so that the force is applied to the middle of the neck, at a 90° angle to its axis. The tensile testing machine then applies force to break the ampoule. The breaking force is recorded at the moment of breakage.
These standards ensure that the break force of ampoules is within an acceptable range, reducing the risk of faulty ampoules reaching the market. Compliance with these standards is vital for manufacturers who want to ensure their products meet regulatory requirements and maintain high-quality control.
The 3-Point Bending Test and Its Relevance to Ampoule Testing
The 3-Point Bending Test is a testing method that is often used to determine the strength and durability of materials, including ampoules. In this test, a sample is placed on two supports while a force is applied at the center to measure its response to bending. Although not directly related to break force testing, the 3-Point Bending Test is useful in evaluating other properties of ampoule materials that may affect their break strength, such as brittleness or flexibility.
ISO 9187 also references the 3-Point Bending Test in certain contexts, emphasizing the comprehensive nature of materials testing in the pharmaceutical packaging industry. By using both break force and bending tests, manufacturers can assess the full range of mechanical properties of ampoules.
Key Features of Ampoule Break Force Tester
Modern Ampoule Break Force Testers, such as the BST-01 model, come equipped with a range of features that enhance their functionality and ease of use:
- Precision: Stepper motors and ball-lead screws ensure precise force application.
- Adjustable Speed: The speed of the test can be adjusted to simulate different conditions.
- Multiple Fixtures: Test fixtures are available for various ampoule sizes and materials.
- Safety Features: The device includes protective covers to prevent injury from broken glass.
- Advanced Control: The PLC control unit allows for seamless operation, and the HMI touch screen simplifies test monitoring and data collection.
Main Parameter of Ampoule Break Force Tester
Test Range | 0~200N (Or as required) |
Speed | 1~500mm/min |
Resolution | 0.1N |
Accuracy | 0.5% F.S. |
Power | 110~ 220V 50/60Hz |
These features make the Ampoule Break Force Tester an invaluable tool for pharmaceutical manufacturers, ensuring that ampoules meet the required safety and performance standards.
FAQs
1. What is the purpose of an Ampoule Break Force Tester?
The primary purpose of an Ampoule Break Force Tester is to measure the amount of force needed to break the neck of an ampoule. This ensures that the ampoule is sealed correctly and can be safely opened by users without compromising the contents.
2. How does the tester measure the break force?
The tester uses a load cell to detect the exact moment the ampoule neck breaks when a pressing head applies force at a controlled speed. The force is then measured and recorded.
3. What is ISO 9187, and why is it important for ampoule testing?
ISO 9187 is an international standard that specifies the test methods for measuring the break force of ampoules. It ensures that ampoules meet specific safety and durability criteria, which is critical for pharmaceutical packaging.
4. Can the Ampoule Break Force Tester be used for different ampoule sizes?
Yes, the tester comes with various fixtures that can accommodate different ampoule sizes, typically ranging from 1ml to 20ml, allowing for versatile testing across a wide range of products.
5. What additional tests can be performed with an Ampoule Break Force Tester?
In addition to break force testing, the Ampoule Break Force Tester can be used for other tests like compression, cap opening force, syringe gliding force, puncture resistance, and stopper penetration testing, making it a versatile tool for pharmaceutical packaging.