Penetrability Tester
Needle Penetration Test Method

The penetrability tester is a critical instrument used in various industries, primarily to assess the penetrability of materials such as rubber, plastics, and pharmaceuticals. This device measures the force required for a needle to penetrate a material, providing vital data that ensures product performance and compliance with international standards. With its ability to accurately simulate real-world conditions, the needle penetration test is essential in quality control processes.

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What is a Needle Penetrability Test?

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?

The needle penetrability tester works by applying a controlled force to a needle or probe, which is then pushed into the material being tested. The tester measures the depth of the penetration or the force required for the needle to reach a specific depth. Various factors like material elasticity, thickness, and density will affect the results.

In many cases, the test method follows international standards, which help ensure consistency and reliability in testing results. Standards such as USP 381, USP 382, ISO 7864, and ISO 8871-5 offer precise guidelines for conducting tests, making it possible to assess the quality and performance of materials in a standardized way.

Needle Penetration Force and Test Method

Needle penetration force refers to the force required for a needle to pierce a material. It is one of the key variables measured during the test. This force refers to the amount of pressure required to penetrate the material, which varies based on the material’s composition and intended use.

The needle penetration test method is designed to simulate real-world conditions, such as the force exerted by a device during insertion or interaction with a product. This parameter is crucial for applications such as syringeable pharmaceutical packaging, IV bags, and elastomeric closures.

A high-precision Penetrability Tester measures this force dynamically, simulating real-world conditions. For example, in pharmaceutical packaging, ensuring consistent penetration force guarantees that medical personnel can administer drugs safely without material failure.

There are two main types of needle penetration tests:

  1. Needle Drag Force Test: This method evaluates the resistance a needle experiences as it is dragged through the material. It’s useful for testing materials with varying thicknesses and densities, providing insights into their texture and resistance.
  2. Needle Penetration Depth Test: This method measures how deeply the needle can penetrate a material under a controlled force, helping manufacturers determine the product’s ability to maintain its integrity under pressure.

Needle Penetration Test Method: Step-by-Step Procedure

The needle penetration test method involves standardized steps to ensure repeatability and accuracy:

  1. Sample Preparation: Secure the material (e.g., rubber stopper, film) in the tester’s fixture.
  2. Needle Selection: Use a needle size specified by standards (e.g., ISO 7864 for infusion equipment).
  3. Test Execution: Drive the needle into the material at a controlled speed while recording force data.
  4. Analysis: Evaluate peak force (penetration force) and residual drag force.

This method aligns with USP 382 for elastomeric closures, ensuring compatibility with parenteral products.

Choosing the Right Needle Penetrability Tester

When selecting a penetrability tester, consider:

Test Range

0~200N (Or as required)

Stroke

200mm (without clamp)

Speed

1~500mm/min(or as required)

Displacement Accuracy

0.01mm

Accuracy

0.5% F.S.

Output

Screen, Microprinter, RS232(optional)

Power

110~ 220V 50/60Hz

Features and Benefits of the Needle Penetrability Tester

  • PLC Control Unit with 7-Inch HMI Touch Screen: The needle penetrability tester is equipped with a sophisticated PLC control unit, paired with an intuitive 7-inch HMI touch screen, offering seamless operation and user-friendly navigation.
  • Precision Ball Screw and Stepper Motor: For precise and consistent testing, the tester utilizes a high-quality ball screw mechanism and stepper motor, ensuring accurate and repeatable penetration measurements.
  • Variable Test Speed Capability: The needle penetrability tester offers flexible testing options with variable test speed capabilities, allowing users to adjust the speed based on specific testing requirements.
  • Multiple Sample Jigs and Needle Types: The instrument comes with a variety of sample jigs and needle types, making it adaptable to different materials and applications, ensuring comprehensive testing options.
  • Enhanced Safety Features: Equipped with position restrictors and overload protection, the tester ensures safe operation, preventing damage to the machine and the material being tested.
  • Automatic Return Function: To save time and increase efficiency, the needle penetrability tester automatically returns to its starting position after each test, streamlining the testing process.
  • Embedded Dot Matrix Microprinter: For long-term data retention and easy record-keeping, the tester includes an embedded dot matrix microprinter, allowing for immediate printouts of test results and ensuring compliance with documentation requirements.

Industry Standards for Needle Penetration Test Method

Several standards ensure that needle penetration testing is consistent and reliable. Some of the key standards include:

  • USP 381: This standard provides guidelines for testing the physical properties of rubber stoppers, ensuring their ability to maintain their integrity when penetrated by a needle.
  • USP 382: Similar to USP 381, this standard focuses on the testing of elastomeric components used in pharmaceutical packaging, ensuring they can withstand penetration without compromising product safety.
  • ISO 7864: This standard specifies requirements for the performance of medical needles, ensuring their ability to penetrate materials with minimal resistance and risk of injury.
  • ISO 8871-5: This is crucial for assessing the quality of rubber components used in injectable drug delivery systems, ensuring the rubber’s suitability for use in medical devices.

These standards help manufacturers ensure their products are compliant with regulatory requirements and meet the expectations of end-users.

Applications of the Penetrability Tester

The needle penetrability tester is widely used in several industries:

  • Pharmaceuticals: Ensures that rubber stoppers and seals can withstand the forces encountered during the manufacturing and use of pharmaceutical products.
  • Medical Devices: Assesses the quality of rubber seals and gaskets used in syringes and vials.
  • Packaging: Tests materials like plastic films and coatings to ensure they can endure forces applied during handling and use.
  • Food & Beverage: Ensures that packaging materials maintain integrity and prevent contamination.

Ready to enhance your material testing with precision and efficiency?

Our Penetrability Tester is designed to meet the highest industry standards, providing accurate results and streamlined operations. With advanced features like variable test speeds, safety protections, and easy data management, it’s the ideal solution for pharmaceutical, medical device, and packaging testing. Contact us today to learn more or schedule a demo and experience firsthand how our tester can optimize your testing processes!
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