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Source: Link Testing Instruments Co.,Ltd.

I. Significance of testing: Importance of tensile properties of pharmaceutical packaging

As a key barrier to protect drugs, the mechanical properties of pharmaceutical packaging materials are directly related to the safety and stability of drugs during storage, transportation and use. Tensile properties are the core indicators for evaluating the tensile strength and deformation characteristics of plastic films and sheets, and directly affect the sealing, impact resistance and durability of packaging. If the tensile strength of the material is insufficient or the elongation at break is low, it may cause damage and leakage of the packaging, and even affect the efficacy of the drug. Therefore, accurately measuring tensile properties through standardized testing methods is the core link of quality control of pharmaceutical packaging material companies and an important guarantee for the compliance of drugs on the market.

 

1. II. Pharmacopoeia standard requirements: 2025 Pharmacopoeia 4005 and YBB00112003-2015 key points

 

The 2025 edition of the Chinese Pharmacopoeia, Part Four, General Rules 4005 "Determination of tensile properties of plastics" and the industry standard YBB00112003-2015 "Determination of tensile properties" jointly standardize the testing process and technical requirements of pharmaceutical plastic materials.

 

1. Scope of application: Applicable to pharmaceutical plastic films and sheets (such as polyethylene, polypropylene, etc.) with a thickness of ≤1mm, covering the determination of tensile strength and elongation at break.

 

2. Test environment: It needs to be carried out in a constant temperature and humidity environment with a temperature of 23±2℃ and a humidity of 50±5%. The sample needs to be pretreated for ≥4 hours to ensure data stability.

 

3. Sample preparation: Dumbbell-shaped (type I, II, III) or long strip (type IV) samples are used, with no less than 5 samples per group, and the edges must be smooth and undamaged.

 

4. Test parameters:

 

Tensile speed: 1-500mm/min (low speed for hard materials, high speed for soft materials) according to the material type.

 

Key formula: Tensile strength σ=P/(b·d) (P is the maximum load, b is the width of the specimen, and d is the thickness); Elongation at break ξ=(Lv-L)/L×100% (L is the initial gauge length, Lv is the gauge length at break).

 

5. Equipment requirements: A high-precision force measurement system (within ±1%), a displacement measurement system (resolution 0.1mm) and an adapter fixture are required to ensure the accuracy and repeatability of the test data.

 

III. LTS-05 Intelligent Electronic Tensile Testing Machine: Ideal for High-Precision Testing

Automatic Tensile tester LTS-05

 

The LTS-05 intelligent electronic tensile testing machine developed by Link Testing Instruments Co.,Ltd. strictly follows the pharmacopoeia and industry standards, and provides an efficient solution for tensile performance testing of pharmaceutical packaging materials.

 

Core parameters:

 

Force range: 500N (standard), supports 30N-2000N multi-specification sensors.

 

Accuracy level: force accuracy is better than 0.5 level, meeting the pharmacopoeia's requirements for ±1% error.

 

Speed adjustment: 0.001-500mm/min stepless speed regulation, adapting to the testing needs of different materials.

 

Fixture design: standard manual fixture (pneumatic fixture optional), clamping width 30mm/50mm, compatible with dumbbell-shaped and long strip specimens.

 

Multiple test procedures: integration of stretching, peeling, tearing, etc., to meet the multi-dimensional performance evaluation needs of pharmaceutical packaging materials.

IV.Conclusion

The tensile performance testing of pharmaceutical packaging materials is an important part of drug quality assurance. Through the implementation of the 2025 Pharmacopoeia 4005 and YBB00112003-2015 standards, combined with the application of high-precision equipment such as the LTS-05 intelligent electronic tensile testing machine, pharmaceutical packaging material companies can achieve scientific evaluation of material properties, effectively reduce the risk of packaging failure, and promote the industry to develop in the direction of high quality and standardization.

For more details please visit www.linktesting.org