Source: Link Testing Instruments Co.,Ltd.
Heat seal strength is a key indicator for measuring the seal strength between pharmaceutical aluminum foil and rigid sheets such as PVC. Insufficient seal strength can lead to leakage, moisture absorption, or oxidation during transportation and storage, seriously impacting the stability of the drug. Excessive seal strength can negatively impact the user experience when opening the package. Based on "YBB00152002-2015 Pharmaceutical Aluminum Foil" and "YBB00122003-2015 Heat Seal Strength Test Method," Link Testing testing instrument can efficiently test the heat seal strength of pharmaceutical aluminum foil and PVC/PVDC rigid sheets. The following is a detailed description of the YBB00152002-2015 Heat Seal Strength Test Method for Adhesive Layers of Pharmaceutical Aluminum Foil, based on the standard requirements and relevant test methods:
I. Test Purpose
To evaluate the heat seal strength between pharmaceutical aluminum foil and polyvinyl chloride (PVC) or polyvinyl chloride/polyvinylidene chloride (PVC/PVDC) composite rigid sheets to ensure reliable bonding during actual packaging and prevent drug leakage or contamination.
II. Testing Procedures and Instrument
Take two sheets of 100mm x 100mm pharmaceutical aluminum foil and overlay them with a PVC or PVC/PVDC sheet of the same size, ensuring precise alignment between the adhesive layer and the sheet surface.
Link Testing’s LTH-H3 Heat Seal Tester, the set technical parameters:
Temperature: 155°C ± 5°C (temperature control accuracy ± 0.2°C)
Pressure: 0.2 MPa (pressure range 0.05-0.7 MPa)
Time: 1 second (time range 0.01-999.99 seconds)
After heat sealing, cool the sample to room temperature.
Cut the heat-sealed sample into 15mm wide strips and test the three central strips. Use Tensile tester XLW-500N designed & produced by Link Testing to perform a 180° peel test at a speed of 200mm/min ± 20mm/min, recording the force readings.
PVC Rigid Sheet: Heat Seal Strength ≥ 7.0N/15mm
PVDC Composite Rigid Sheet: Heat Seal Strength ≥ 6.0N/15mm
III. Link Testing instrument Advantages
Precise Control: The LTH-H03 Heat Seal Tester utilizes a digital PID temperature control system, ensuring heat seal temperature, pressure, and time errors of ≤±1%, ensuring repeatability.
Efficient Testing: The XLW-500 Intelligent Electronic Tensile Testing Machine is equipped with a high-precision sensor, records peel curves in real time, and supports data export and analysis.
Compliant Design: The instrument strictly adheres to YBB standards and the General Principles of the Chinese Pharmacopoeia, meeting pharmaceutical industry GMP regulations.
IV. Related Standards
YBB00152002-2015: Standard for Pharmaceutical Aluminum Foil.
YBB00122003-2015: Determination of Heat Seal Strength.
YBB00212005-2015: Standard for PVC Solid Pharmaceutical Rigid Sheets.
YBB00222005-2015: Standard for PVC/PVDC Composite Rigid Sheets.
Summary:
Standard YBB00152002-2015 specifies how to quantify the performance of the adhesive layer of pharmaceutical aluminum foil using the "heat seal-peel" mechanical test method. This ensures the sealability and safety of pharmaceutical packaging.
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