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Source: Link Testing Instruments Co.,Ltd.

I. Why is Tensile Strength Testing Essential for Pharmaceutical-Grade Rigid PVC Sheets?

 

As a core material in pharmaceutical packaging, pharmaceutical-grade rigid PVC sheets directly impact the airtightness, stability, and safety of medicinal products. According to the requirements of the National Standard for Pharmaceutical Packaging Materials (YBB00212003), tensile strength is one of the critical testing parameters for pharmaceutical-grade rigid PVC sheets. Through this test, the material's ductility and fracture resistance under mechanical stress can be verified. This ensures that, in practical applications, the material can withstand the mechanical stresses encountered during manufacturing, transportation, and storage, thereby preventing product spoilage—such as moisture ingress, oxidation, or contamination—caused by material rupture.

II. Specific Requirements for Tensile Strength under the YBB Standard

 

The YBB standard explicitly stipulates that pharmaceutical-grade rigid PVC sheets must possess a tensile strength of ≥ 45 MPa and an elongation at break of ≥ 120%. This requirement is based on the following considerations:

 

1.  **Guaranteeing Packaging Integrity:** Pharmaceutical aluminum-plastic blister packaging is formed through a heat-sealing process. If the tensile strength of the rigid PVC sheet is insufficient, the material is prone to deformation or fracture during processing, leading to blister seal failure.

 

2. **Verifying Environmental Adaptability:** Pharmaceutical products may be subjected to various environmental conditions, such as high-temperature sterilization or low-temperature storage. Consequently, the packaging material must exhibit stable mechanical properties to prevent embrittlement or softening triggered by temperature fluctuations.

 

III. Tensile Strength Testing Methods and Operational Procedures

 

In accordance with YBB standards, the testing process must strictly adhere to the following steps:

Automatic Tensile Tester XLW-500N

1. Sample Preparation

Select PVC rigid sheets from the same production batch and cut them into standard test specimens measuring 15 mm in width and 150 mm in length. The edges of the specimens must be smooth and free of burrs to prevent testing errors.

 

2. Test Equipment Calibration

Utilize an electronic universal testing machine (with an accuracy of ±1%). In accordance with the ISO 527-3 standard, set the initial grip separation to 50 mm and the tensile speed to 500 mm/min.

 

3. Testing Procedure

Secure the test specimen vertically within the grips. Activate the equipment to apply tension at a constant speed until the specimen fractures; the system will automatically record the maximum tensile force and the elongation at break.

 

4. Result Calculation

Tensile Strength = Maximum Tensile Force (N) / Cross-sectional Area of ​​Specimen (mm²); Elongation at Break = [(Gauge Length at Break) – (Original Gauge Length)] / (Original Gauge Length) × 100%.

 

Conclusion

Tensile strength testing is not only a mandatory requirement under YBB standards but also a critical component for pharmaceutical packaging material manufacturers in managing risk. By implementing scientific and standardized testing procedures, manufacturers can effectively ensure the mechanical integrity of pharmaceutical-grade PVC rigid sheets, thereby providing a fundamental safeguard for drug safety.

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