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2025 Pharmacopoeia: Aluminum Foil Bursting Strength – Method and Instrument

Nov 30,2025

Source: Link Testing Instruments Co.,Ltd.

As a core material for pharmaceutical packaging, the physical properties of pharmaceutical aluminum foil directly affect the sealing, barrier properties, and long-term stability of the medicine. Bursting strength is a key indicator of aluminum foil's compressive strength. Insufficient bursting strength may lead to packaging breakage due to external forces during transportation, storage, or use, resulting in drug contamination, spoilage, or safety hazards. Therefore, scientifically testing the bursting strength of aluminum foil is a crucial step in ensuring the quality of pharmaceutical packaging.

 

According to the 2025 edition of the Chinese Pharmacopoeia, Part IV, General Chapter 4055, "Determination of Physical Properties of Aluminum Foil," and the YBB00152002-2015 standard, "Pharmaceutical Aluminum Foil," the bursting strength test must simulate an actual pressure environment using a hydraulic system to assess the structural integrity of the aluminum foil. The test results must meet the minimum values ​​specified in the pharmacopoeia (e.g., 98 kPa) to ensure the reliability of the aluminum foil in practical applications.

 

Specific Requirements for Bursting Strength Test in Pharmacopoeia Standards

 

Pharmacopoeia Standard 4055 specifies the operational procedures and technical parameters for the bursting strength test:

 

Sample Preparation: Take three 40mm × 40mm pharmaceutical aluminum foil samples, ensuring they are free of creases, cracks, or other damage;

Test Environment: The test must be conducted at a temperature of 15℃~50℃ and a relative humidity ≤80%;

Test Method: Fix the sample with the adhesive side facing the elastic film between the upper and lower clamps. Apply pressure using a hydraulic system at a rate of 95±5ml/min until the sample bursts, and record the maximum pressure value (in kPa);

Acceptance Criterion: The bursting strength of each sample must not be less than 98kPa.

Furthermore, the standard specifies clear requirements for the film resistance, clamping force, and sealing performance of the instrument. For example, when the film protrusion height is 9mm, the resistance range must be 30±5kPa, and the clamping force should be ≥430kPa (adjustable).

 

Technical Features of the Link Testing NPD-1000S Aluminum Foil Bursting Strength Tester

Full-Automatic Bursting Strength Tester NPD-1000S

The Link Testing NPD-1000S aluminum foil bursting strength tester is designed in strict accordance with Pharmacopoeia 4055 and YBB00152002-2015 standards. It is suitable for testing the bursting strength of packaging materials such as pharmaceutical aluminum foil and metal tubing. Its testing principle is based on hydraulic loading technology:

 

  1. Testing Principle:

 

The sample is clamped between upper and lower clamps, forming a seal with an elastic diaphragm;

Hydraulic fluid is pumped in at a constant rate (95±5ml/min), causing the diaphragm to gradually bulge until the sample bursts;

The maximum pressure value at the point of rupture is recorded by a high-precision sensor, which is the bursting strength of the sample.

 

  1. Core Parameters and Functions:

 

Measurement Range: 40~1600kPa, resolution 0.1kPa, accuracy ≤±0.5%;

Pressure Application Rate: 95±5ml/min, meeting the pharmacopoeia requirements for hydraulic loading rate;

Film Performance: With a protrusion height of 9mm, resistance range 30±5kPa, ensuring repeatability of test results;

Ease of Operation: Equipped with a color touchscreen for real-time data display and supports micro-printer output.

 

Value in Testing Practice

 

In pharmaceutical packaging production, burst strength testing is not only a mandatory requirement for pharmacopoeia compliance but also a crucial tool for companies to optimize processes and control costs. Regular testing can promptly identify weaknesses in aluminum foil materials, allowing for adjustments to coating processes or substrate parameters, thereby improving product quality.

For more details please visit www.linktesting.org

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