Abstract: Medical infusion paste is a kind of medical product commonly used in infusion. Peel strength is an important factor affecting its performance. In this paper, Labthink MED-01 Pharmaceutical Packaging performance tester to test equipment, tested for peel strength of a brand infusion paste and describes the testing process, the test principle, parameters and the scope of equipment, etc., for enterprises to monitor infusion paste The adhesive properties are provided as a reference.

Key words: medical infusion paste, peel strength, adhesive performance, shedding, not easy to tear off, medical packaging performance tester, medical tape

1. significance

Medical infusion paste is an indispensable medical product in the infusion process. It is mainly used to fix the infusion catheter and needle handle during the infusion process, and has a certain protective effect on the puncture site of the infusion. The medical infusion paste is mainly composed of three parts: a medical tape, an absorbent pad and a separator. The medical tape is used for fixing, and the medical non-woven fabric or medical polyvinyl chloride (PVC) or polyethylene (PE ) coated with medical adhesive on the surface. ) or medical polyurethane film (PU) and other materials, the size of the adhesive directly affects whether the infusion paste can fully exert its fixation and protection. If the adhesiveness of the infusion patch is small, the infusion patch will easily fall off during the infusion process, and the fixation effect will be lost; if the adhesiveness of the infusion patch is too large, the infusion patch will not be easily torn off after the infusion is completed, in tearing. In the process, the patient has a strong pain and damages the patient's skin, so the medical infusion bag should have a suitable adhesiveness. There are two main indicators for the viscosity of infusion paste, which are tackiness and peel strength. This paper mainly tests the peel strength to characterize its adhesive properties.

2. Test samples

Medical infusion stickers produced by a company.

3. Detection basis

The test process is based on the pharmaceutical industry standard YY/T 0148-2006 "medical tape Relevant provisions on the peel strength test in the General Requirements.

4. Test equipment

The test equipment used in this paper is the MED-01 medical packaging performance tester for medical packaging testing independently researched and produced by Jinan Languang Electromechanical Technology Co., Ltd.

4.1 Test principle

In this test, the peel strength of the sample is obtained by testing the change in the force value of the infusion applied to the test panel during peeling. The fixture of the device is divided into upper and lower parts. The upper clamp is a dynamic clamp, which can be moved upward according to the set separation speed of the clamp. During the test, the infusion paste and the test plate are respectively clamped in the two clamps, and move with the upper clamp. The peeling is realized; the force value sensor is arranged in the upper clamp, and the displacement sensor is arranged inside the device. During the peeling process of the sample, the force value sensor and the displacement sensor can respectively monitor the force value and the displacement change in real time, thereby calculating the peeling of the sample. strength.

4.2 Equipment parameters

l   The test range of the device is 250 N , and it can be selectively configured with 50 N , 100 N and 500 N. The test accuracy is better than 0.5 , which effectively guarantees the accuracy of the test results.

l   The device has a stroke of 600 mm .

l   The equipment supports two-way test mode of tension and compression. 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 .

l   Intelligent configuration such as limit protection, overload protection and automatic return to ensure the user's operation safety.

l   A test machine integrates sixteen independent test procedures, such as medical instruments, foam stripping, compression, and stretching, to provide users with a variety of test items.

l   Labthink developed using the latest embedded computer system platform, with the latest operating software, support Lystem ^TM Laboratory Data Sharing System, test results and test reports unified management.

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 , GB/T 1040.1-2006 ~ GB/T 1040.4-2006 , GB/T 1040.5-2008 , GB/T 4850-2002 , GB/T 12914- More than 30 items such as 2008 , GB/T 2790 ~ GB/T 2792 , ISO 37 , ASTM E4 , ASTM D882 , ASTM D1938 , QB/T 2358 , JIS P8113 , YY 0613-2007 , YBB 00042002 .

5. Test process

(1) Place the sample to be tested in the laboratory environment at 20 °C and 65% RH for 24 h .

(2) Five specimens of 400 mm in length and 25 mm in width were cut from the surface of the sample .

(3) tear off the release paper, attach the sample to the center of the stainless steel plate ( test plate ) , make the two sides of the sample parallel to the two long sides of the steel plate, and roll it 4 times along the length of the sample with a pressure roller . , placed for 10 min .

(4) Clamp the free end of the sample and the test plate in the upper and lower fixtures of the device so that the long axis direction of the sample is parallel to the center line of the upper and lower clamps.

(5) Set parameter information such as sample name, sample width, test speed (300 mm/min) , click the test option, and the test starts.

(6) During the test, the system displays the force value during the peeling process of the sample in real time, and automatically displays the test result after the test ends.

(7) Repeat (3) ~ (6) operation until all 5 samples have been tested. The test results take the average of the test results of 5 samples.

6. Test results

The average peel strength of the measured infusion patch samples was 0.1541 kN/m , which was 1.541 N/cm .

7. Conclusion

The adhesive properties of medical infusion stickers are important factors related to their usability. This paper verifies the adhesiveness of the infusion test by testing the peel strength of the infusion patch. The equipment is easy to operate, the automation of the test process is high, and the accuracy of the test results. High and repeatable, it can truly reflect the peel strength of the tested samples. The MED-01 Medical Packaging Performance Tester is a test equipment for the performance testing of pharmaceutical packaging. It can test different performance indexes of various types of samples and has a very high cost performance. Labthink is a high-tech enterprise that has always been committed to the R&D and production of packaging testing equipment. The equipment currently developed includes gas permeation tester, water vapor transmission tester, membrane separation tester, intelligent electronic tensile testing machine, and friction. Coefficient meter, thickness gauge, evaporation residue constant weight meter, carton compression tester, torque meter, heat seal tester, seal tester, etc.