Verification method for the adhesiveness of aseptic surgical films - test of peel strength

Abstract: Sterile surgical membrane is an important part of preventing bacterial infection during surgery. The viscosity of the membrane is an important factor affecting the performance. In this paper, a test of the peel strength of aseptic surgical membrane samples is introduced to characterize its viscosity characteristics. The test method provides a reference for monitoring the peel strength of the aseptic surgical film by describing the test principle, equipment parameters, application range and test method.

Key words: aseptic surgical film, adhesive, peel strength, intelligent electronic tensile testing machine, stainless steel plate, pressure roller

1 , meaning

Aseptic surgical film refers to a medical material made of a film such as polyurethane or polyethylene, which is coated with a medical pressure-sensitive adhesive on its surface, and is used for attaching to a surgical site during surgery to prevent the skin from being carried. The dandruff of the bacteria spreads to the surgical wound, preventing the deep microscopic microorganisms around the surgical incision from migrating to the surface of the skin and spreading to the surgical incision, thereby preventing infection of the surgical incision. The viscosity of a sterile surgical film is an important factor influencing its ability to fully exert its above-mentioned effects. This is because if the viscosity is poor, the sterile surgical film and the skin do not fit well during the operation, and even if separation occurs, it will weaken. Sterile surgical membranes block the dandruff and microbes, even lose this function, and also cause inconvenience to the surgical operation, so viscosity is an important performance of the sterile surgical membrane.

The indicators for characterizing the viscosity of aseptic surgical films are mainly tackiness and peel strength. The peel strength is tested in this paper.

Figure 1 sterile surgical membrane

2 , testing basis

The test procedure is based on the YY 0852-2011 "disposable sterile surgical membrane," part of the relevant provisions of the standard peel strength test B.3.

3 , test samples

The test sample used in this article is a sterile surgical film provided by a company.

4 , test equipment

In this paper, the MED-01 medical packaging performance tester is used as the test equipment to test the sample. The equipment is independently developed and produced by Jinan Languang Electromechanical Technology Co., Ltd.

Figure 2 MED-01 medical packaging performance tester

4.1 Test principle

The peel strength test is the force value required to peel the sterile surgical film from the stainless steel plate. The sample of the sterile surgical film is pasted on the stainless steel plate. During the test, the unfixed end of the sample and the stainless steel plate are respectively clamped in the upper and lower fixtures of the device, the upper clamp can move upward, the lower clamp is fixed, and the upper clamp is fixed. When moving upward according to the set speed, the sample will be peeled off from the surface of the stainless steel plate. The force value generated in the process is monitored and recorded in real time by the force value sensor configured in the upper clamp. After the test, the test value is calculated and displayed. Peel strength.

4.2 Equipment parameters

The test range of the equipment is 250 N , and optional 50 N , 100 N , 500 N , the test accuracy is better than 0.5 , which effectively guarantees the accuracy of the test results; the stroke is 600 mm ; supports stretching and compression The test mode, the progress of the fixture and the return speed are available in 6 steps , which are 10 mm/min , 50 mm/min , 100 mm/min , 150 mm/min , 200 mm/min , 300 mm/min ; Intelligent configuration such as limit protection, overload protection and automatic return to ensure the user's operation safety; a test machine integrates 16 independent test procedures such as medical instruments, foam stripping, compression and stretching, providing users with more A selection of experimental projects; the embedded computer system platform newly developed by Labthink zui , coupled with zui's new operating software, supports the Lystem TM laboratory data sharing system, and unified management of test results and reports.

4.3 Scope of application

(1) This equipment is suitable for testing the performance of 90 degree peeling, 180 degree peeling, tensile properties, tear resistance and heat seal strength of medical packaging bags .

(2) This equipment is suitable for rubber plug penetration force, ampoule breaking force, syringe sliding performance, syringe body tightness, needle penetration force, needle needle tube connection firmness, needle needle seat and sheath combining force , plastic blood bag pressure emptying test and other indicators test.

(3) After special modification or special accessories, the equipment can also be used for testing various performance indexes such as rubber plug pull-out force, tape unwinding force, protective film separation force, combined cover opening force and release paper separation force.

(4) This equipment complies with a number of national and international standards, such as GB 8808 , YY 0852 , GB/T 1040.1 , GB/T 1040.2 , GB/T 1040.3 , GB/T 1040.4 , GB/T 1040.5 , GB/T 4850 , More than 30 items such as GB/T 12914 , GB/T 2790 , GB/T 2791 , GB/T 2792 , ISO 37 , ASTM E4 , ASTM D882 , ASTM D1938 , QB/T 2358 , JIS P8113 , YY 0613 , YBB 00042002 .

5 , the test process

(1) The sample is placed in 22 ℃, 60% RH conditioning environment of 24 h, from the surface of the sample cut out to a width 25.0 mm, sample length 400 mm of five.

(2) Take one sample, peel off the protective layer, and immediately affix the sample to the middle of the stainless steel plate. The length of the bonded sample should be at least 200 mm . The two sides of the sample and the two long sides of the stainless steel plate parallel. After rolling 4 times along the length of the sample by a press roll , it was left for 10 min .

(3) Install the free end of the sample and the stainless steel plate in the upper and lower fixtures of the equipment, set the parameter information such as the sample name, sample width, test speed, etc. Click the test option and the test starts. The device displays the real-time force values ​​during the stripping process and reports the results at the end of the test.

(4) Test the remaining 4 samples according to the procedures in (2) and (3) .

6 , test results

The tested samples of five test results were 5.314 N / 25mm to, 6.076 N / 25mm, 5.904 N / 25mm, 5.731 N / 25mm, 6.008 N / 25mm, the peel strength of the sample test results taken samples of five The average value is 5.807 N/25mm .

7 , conclusion

Viscosity has an important influence on the performance of a sterile surgical film, and peel strength is one of the indicators reflecting the viscosity of a sterile surgical film. In this paper, the peel strength of the sample is tested by the pharmaceutical packaging performance tester. The operation of the device is simple, the degree of intelligence is high, the test accuracy is high, and the test process data is clear. From the test results, the peel strength of the sample is 5.807 N/25mm . That is , if the sample with a peel width of 25 mm requires a force value of 5.807 N , the average force required to peel the width per 1 cm is 2.323 N , which satisfies the requirement of not less than 1.0 N in the standard. Jinan Languang Electromechanical Technology Co., Ltd. is a high-tech enterprise specializing in R&D, production and packaging testing services for packaging testing equipment. The existing equipment can test the oxygen barrier performance, moisture barrier performance, sealing performance, solvent residue and tensile resistance of pharmaceutical packaging. Strength, tear performance, holding viscosity and many other performance indicators . The more you understand, the more you trust! Labthink is looking forward to enhancing technical communication and cooperation with enterprises and institutions in the industry.

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