Detection method of thermal sealing strength of medical plastic suction box

Abstract: Plastic suction packaging is a common kind of medical pharmaceutical packaging at present, with its strong protection, good sterilization effect, long storage period. It reduces loss and costs, and is easy to use. Based on those advantages, there have been more and more applications for it. In the performance indicators of plastic suction packaging box, thermal sealing strength is one of the most important. Its strength directly affects the quality of packaging. In this paper, C610 (M) Auto Tensile Tester, independently developed by Labthink Instruments Co., Ltd. is used to test the thermal sealing strength of the medical plastic suction box, and briefly describes the principle, parameters and specific test process of the equipment, so as to provide reference for the pharmaceutical packaging industry to monitor the thermal sealing strength of plastic suction packaging.

Key words: thermal sealing strength, sealing strength, heat sealing strength, paper and plastic packaging, plastic suction packaging

1. Significance

Medical suction plastic packaging is generally composed of two sides. One side is a permeable paper permeating and discharging sterilization factors, and the other side is a transparent composite film or hard suction plastic tray. In the process of sterilization, the permeable paper allows steam to permeate, so as to achieve the purpose of sterilizing the internal, the sterilized paper-plastic packaging box can effectively prevent the invasion of bacteria, and the plastic is clearly visible to the packed contents, which is easy to use and manage. Under the standard of ensuring that the barrier conditions between the paper surface and the thermoplastic surface meets the requirements, the thermal sealing strength has become an important factor affecting the packaging quality. Thermal sealing requirements are clearly specified in the 5.7.10 package requirements of 5.7 packaging in WS310.2-2016 Hospital Disinfection Supply Center, Part 2: Technical Operation Specification for Cleaning, Disinfection and Sterilization.

Figure 1 A paper-plastic packaging box

2. Medical Standards

At present, the domestic testing standards for medical thermal sealing strength (also known as thermal sealing strength and sealing strength) are 4008 in 2020 Pharmacopoeia IV, and YBB00122003-2015 “Thermal Intensity Test Method”.

3. Test Sample

The test sample in this paper is a heat-sealed and complete disposable sterile packaging medical plastic suction box.

4. Test Equipment

In this paper, Labthink C610 (M) Auto Tension test machine is used to test the thermal sealing strength of the medical plastic suction packaging box. As shown in Figure 2.

Figure 2  C610 (M) Auto Tensile Tester

4.1 Equipment Principle

The sample is clamped between the two clamps of the tester, and the two clamps do relative movement. Through the force value sensor and the displacement sensor built in the instrument, the force value and displacement changes during the test, so as to calculate the thermal sealing strength, peel, stretch, tear, deformation and other performance indicators of the sample.

4.2 Scope of Applications

Basic application of test items: tensile strength and deformation rate, tension-to-break force, thermal sealing strength performance, tear resistance, 180 degrees stripping, 90 degrees peeling, fixed extension tensile test, lowering test, puncture retention force;

l  Film: tensile strength and deformation rate, tensile force, thermal sealing strength, peeling strength, puncture force, shear performance and other film packaging performance tests.

l  Containers: puncture force and pulling force of infusion bag cover, puncture/pulling force of soft rubber bottle plug, opening force of combined cover, tearing force of oral liquid cover, puncture/pulling force, peeling force of hose cover, opening force of yogurt cup, jelly cup cover film and other container packaging performance tests.

l  Others: the pulling force of toothbrush bristles, contact lenses, tape 90 stripping force, tape unwinding force and other product performance tests.

l  Applicable standards: In addition to the above pharmaceutical packaging standards, the equipment can meet ISO137, GB8808, GB/T1040.1-2006~GB/T1040.4-2006, GB/T1040.5-2008, GB/T4850-2002, GB/T12914-2008, QB/T2358, ASTM E4, ASTM D882, ASTM D1938 and other domestic and foreign standards.

l  C610M has a wealth of applications, equipped with more than 100 different fixtures for users to choose, can meet the test requirements of more than 1,000 different materials. Labthink also provides customized services to meet the specific test needs of different users.

4.3 Equipment Parameters

l  500N standard configuration; 50N, 100N, 250N, 1000N optional; and 5N customizable.

l  (0-500) mm/min can be set freely to achieve variable speed.

l  Pneumatic clamp-holding mode of the test sample.

l  Sample width: 30mm (standard fixture), 50mm (optional fixture).

l  The stroke distance of the equipment is 950mm.

l  It meets the data traceability requirements of China GMP and meets the needs of the pharmaceutical industry (optional).

l  Integrated system design, instrument and software in one, without external computer.

l  Limit protection, overloading protection, automatic return and other intelligent design to ensure operation safety.

5. Test Procedures

5.1 Sample Preparation

Use the sampler to take 10 test strips of 15mm width from the thermal seal test site for thermal joint strength testing.

5.2 Test Process

Both ends of the test spline are clamped in the two clamps of the C610 (M) Auto Tensile Tester, and the sample tightness is moderate, and the axis direction of the sample coincides with the center line of the two fixtures. Set the test speed to 300mm/min, click the Start button to start the test. After the test, the instrument will automatically calculate and record the test results.

Figure 3. Sample Clamping, the hot seal of the sample is completely stripped

6. Test Results

The thermal sealing strength of 10 samples was tested, and the average value was taken as the thermal sealing strength value of the final sample, at 4.365N / 15mm.

7. Conclusion

Labthink C610 (M) Auto Tensile Tester can accurately test the thermal sealing strength of the medical plastic box, the test operation is simple, the data results are good,which can accurately reflect the thermal effect of the medical plastic box. In addition to plastic suction packaging, the equipment can also be used to test the thermal sealing strength of other medical packaging, such as composite film, bag and infusion bag for medical packaging. Labthink has been committed to providing professional testing services and equipment for customers around the world. According to customer needs and special requirements of samples, Labthink has developed a number of tensile testers with different applications, optional ranges and customized fixtures. You can log on www.labthink.com for details. The more you understand, the more you trust! Labthink is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry.