Test methods and instruments for pharmaceutical composite ointment tubes
2026-04-06 03:31:32··#1
**I. Ointment Tube Pressure Resistance Test:** 1. Test Purpose: Composite tubing is made by hot-pressing a composite membrane into a tube. If the process is unstable, it can easily lead to a decrease in strength and leakage. Test Method: Take a sample, tighten the cap to a torque of 30 N·cm-90 N·cm, add compressed air from the end of the tube at a pressure of 0.2 MPa, place it in water, and pressurize continuously for 30 seconds. It should not rupture, and there should be no air bubbles at the weld. 2. Testing Instrument: Use the NJY-20 torque meter from Jinan Labthink Electromechanical Technology Co., Ltd. to tighten the cap of the ointment tube. The tightening force should not be less than 30 N·cm. Then, use the clamp of the LSSD-01 Leakage and Sealing Strength Tester to insert into the end of the ointment tube and place it in a special container (filled with water). Then, according to the standard, introduce 200 kPa of air and test the leakage within 30 seconds. II. Peel Strength Test of Inner Layer and Sub-Inner Layer of Ointment Tube 1. Test Purpose: Since the inner layer and aluminum layer are bonded together, the peel strength test of the inner layer and sub-inner layer is an important parameter for determining the composite state, therefore this test is necessary. 2. Test Method: Test the sample according to the requirements of standard YBB00102003. Note that the peel strength in both the longitudinal and transverse directions must not be less than 5N/15mm. (Note that this must be the average value of the peel strength of the inner layer and sub-inner layer, not the maximum value.) 3. Testing Instrument: The XLW series intelligent electronic tensile testing machine (Labthink) can be used for testing. Take a 15mm wide sample, pre-peel it 50mm, clamp it between the upper and lower fixtures of the intelligent electronic tensile testing machine, set the test speed to 300mm/min, start the test, and obtain the test results. **III. Tensile Strength Test of Ointment Tubes:** 1. Test Purpose: This indicator is crucial for assessing the mechanical properties of materials. 2. Test Method: The test shall be conducted according to the YBB0011-2003 standard. Both longitudinal and transverse tensile strengths must be tested separately, and the strength must not be lower than 16 MPa. Since this material is a composite material, only the load at which the first layer of material breaks is recorded. 3. Test Instrument: An XLW series intelligent electronic tensile testing machine is used for inspection. Take tubes from the same batch. After sampling, clamp the sample between the upper and lower clamps of the tensile testing machine. Set the test speed to 100 mm/min and test the load at which the first layer of material breaks. **IV. Heat Sealing Strength of Tube Body and End :** 1. Test Purpose: The welding strength when the tube is made from a membrane. 2. Test Method: The test shall be conducted according to the YBB0012-2003 standard. The heat sealing strength of the tube body must not be less than 70 N/15 mm, and the heat sealing strength of the tube end must not be less than 20 N/15 mm. 3. Test Instruments: Cut a 15mm wide test piece evenly along the width direction of the sample. Place both ends of the sample on the clamps of the XLW Intelligent Electronic Tensile Testing Machine (Labthink), set the test speed to 100mm/min, and record the test results. [b]V. Barrier Performance Test of Ointment Tubes[/b] 1. Test Purpose: Barrier performance is an important performance indicator considering the barrier properties of ointment tube materials. It plays a key role in controlling the permeability, rancidity prevention, discoloration prevention, hardening prevention, and oil-water separation prevention of flexible tubes. 2. Test Methods: Water vapor permeability is tested according to the method specified in YBB00092003. During the test, the heat-sealed surface should face the side with lower humidity, and the water vapor permeability should not exceed 0.5 g/m².24h. Oxygen permeability is tested according to the standard specified in YBB00082003. During the test, the heat-sealed surface should face the side with lower pressure, and the oxygen permeability should not exceed 0.5 cm³/m².24h. 0.1 MPa. 3. Test Instruments: The Labthink TSY-T series moisture permeability tester and VAC-V series differential pressure gas permeation analyzer are used for testing. These instruments are fully automatic and high-precision, greatly improving testing efficiency. The above information was compiled by Jinan Labthink Electromechanical Technology Co., Ltd., hoping to assist manufacturers and users of pharmaceutical composite ointment tubes in quality control. Our company also has a professional laboratory capable of conducting tests for all the above items. We hope to exchange ideas with industry colleagues on more issues. Editor: He Shiping