Abstract: Multi-layer co-extruded infusion bags do not use raw materials such as plasticizers and adhesives, and the materials are stable and do not react with liquid chemicals such as adsorption and dissolution, thus avoiding harm to the human body caused by the inclusion of fine particles into liquid medicines. However, whether or not the rubber plug used in the mouth of the infusion bag has a problem of desquamation due to the inability to pierce the bag is an issue of great concern for infusion bag manufacturers. This article uses the newly developed MED-01 pharmaceutical packaging performance tester by Jinan Languang Electromechanical Technology Co., Ltd. , and refers to relevant medical packaging standards for puncture force performance monitoring, providing technical and data reference for related industries.

Keywords: multi-layer co-extruded infusion bag, rubber plug desquamation, infusion bag rubber stopper, puncture force, puncture resistance, medical packaging performance tester, drug solution, soft plastic packaging, pharmaceutical packaging

1 , detection significance

At present, infusion bags mainly use composite film formed by co-extrusion process as packaging material, three-layer coextruded composite film mainly composed of polypropylene ( PP ) and elastic material ( SEBS ) and ester copolymer, ethylene methacrylate. The main material structure is a five-layer coextruded composite film consisting mainly of polymer, polyethylene, and modified ethylene - propylene polymer. This type of co-extruded infusion bag does not contain any plasticizers, does not use adhesives, and only generates water and carbon dioxide oxides after incineration; meanwhile, the inner layer is made of PP , PE , which is not easily degraded or peeled off. The stability of the polymer, packaging material and the liquid contact without any reaction, no adsorption phenomenon, no glass bottle Alkali phenomenon, will not cause the packaging material particles dissolved into the liquid, to avoid harm to the human body, is currently the most secure One of the premium infusion packaging materials.

To ensure that the material of the infusion bag itself does not dissolve out particles, it is also required to ensure that the material of the bag mouth plug used during the puncture process has no desquamation phenomenon, such as the use of polyisoprene rubber stopper, which is safe and reliable when in contact with the liquid medicine. In addition, whether the puncture force needed for puncturing the tip of the rubber plug at each position is appropriate or not, determines the number and time of successful puncture during infusion. The smaller the number of punctures and the shorter puncture time, can effectively prevent the rubber insoluble particulate matter from entering the solution. Therefore, the monitoring of the puncture force of the rubber stopper is the key quality performance of the infusion bag product. If the puncture force is too large, the puncture force may be easily punctured, and the number and time of the puncture may be increased. When the puncture force is too small, the rubber plug is easily damaged during transportation and storage.

2 , inspection basis

The detection of the puncture force of multi-layer co-extruded infusion bag can be based on its own material according to YBB00342002 "Multi-layer co-extruded film and bag general" or YBB00102005 "Three-layer co-extrusion infusion film ( I ) , bag" or YBB00112005 "Five layers total The method of " (bag) puncture force " in the " Use Adaptability Test " in the Infusion Film ( I ) and Bags . Three criteria above parameters, the indicator and test process "(bag) piercing" are identical.

3 , test sample

A brand of glucose injection co-extruded infusion bag finished product packaging.

4 , testing equipment

This article uses the MED-01 medical packaging performance tester independently developed by Jinan Languang Electromechanical Technology Co., Ltd. and related test fixtures to test the infusion bag penetration force.

4.1 Test principle

The sample is clamped between the two clamps of the clamp. The two clamps move relative to each other. The force value sensor and the built-in displacement sensor on the movable clamp are used to collect the force value change and displacement during the test. Changes are made to calculate various mechanical properties of the sample.

4.1 Scope of application

(1) Puncture force, heat seal strength, tensile strength, tensile strength and deformation rate, tensile breaking force, tear resistance, 90 degree peeling, 180 degree peeling, and infusion cap puncture force applicable to various packaging materials , Pierce puncture force, Ampoule break force, syringe sliding performance, needle piercing force, needle needle seat and sheath with the ability to detect the performance.

(2) After special customization or fixtures, the equipment can be used for soft rubber stoppers, tearing or pulling force of oral liquid lids, tape unwinding force, protective film separation force, makeup brush, toothbrush bristle pull-out force, sealing film tearing Open force, trouser tear force and other packaging, product performance testing.

(3) A tester integrates sixteen independent test procedures for medical devices, foam compression force, stretching, and peeling, providing users with a variety of test item options.

(4) Meet a number of national and international standards: GB 8808 , GB/T 1040.1 , GB/T 1040.2 , GB/T 1040.3 , GB/T 1040.4 , GB/T 1040.5 , GB/T 4850 , GB/T 12914 , GB /T 17200 , GB/T 16578.1 , GB/T 7122 , GB/T 2790 , GB/T 2791 , GB/T 2792 , GB 14232.1 , GB 15811 , GB/T 1962.1 , GB 2637 , GB 15810 , ISO 37 , ASTM E4 , ASTM D882 , ASTM D1938 , ASTM D3330 , ASTM F88 , ASTM F904 , QB/T 2358 , QB/T 1130 , JIS P8113 , YY 0613-2007 , YBB 00042002 , YBB 00112004 .

4.3 Equipment Parameters

(1) 50 N , 100 N , 250 N , 500 N force sensor of four kinds of specifications are available for selection, and the test accuracy is better than 0.5 . This accuracy is far ahead of the industry, which effectively guarantees the accuracy of the test results.

(2) According to the relevant standards, the equipment provides five kinds of progress and return test speeds of 10 mm/min , 50 mm/min , 100 mm/min , 150 mm/min , and 200 mm/min , which can be freely set according to test standards. set.

(3) The 600 mm long stroke can meet the test of large deformation rate materials.

(4) Sixteen independent test procedures, multiple specifications of force sensors, and two-way tensile compression test mode can meet the user's various test needs.

(5) Intelligent configuration such as limit protection, overload protection, and automatic return to ensure user's operation safety.

(6) A tester integrates sixteen independent test procedures for medical devices, foam compression force, stretching, and peeling, providing users with a variety of test item options

(7) Support LystemTM laboratory data sharing system, unified management of test results and test reports.

5 , the test process

(1) Take several infusion bags that are intact and place them in a standard environment of 23 °C and 50% RH .

(2) Set the parameter width and test speed ( 200 ± 20 mm/min for this test ) in the instrument system .

(3) Install a metal trocar that complies with the standard for disposable infusion sets ( GB 8368-2005 ) on the movable chuck of the MED-01 Pharmaceutical Packaging Performance Tester.

(4) Fix the mouth of the infusion bag with a special clamp so that the plastic part of the bag mouth will be aligned with the trocar needle.

(5) Click to start the test button. After the piercer pierces the rubber plug at a fixed speed, the test is completed and the instrument automatically displays the maximum puncture force value.

(6) Repeat (3) ~ (5) test operations until all samples have been tested.

6 , test results

The average puncture force of the multi-layer co-extruded infusion bag tested in this article is 74.1 N , which is in line with the product requirements of the “ multiple co-extruded infusion bag YBB series standards ” where the metal puncture device's puncture force must not exceed 80 N.

7. Conclusion

Whether the multi-layer co-extruded infusion bag pouch plug is easy to pierce and prevent the rubber stopper particles from falling into the liquid is an important indicator of the safety applicability of the infusion bag packaging, Labthink 's MED-01 medicine packaging performance tester can effectively monitor Infusion bag puncture force, and can obtain accurate and stable test data. Labthink has always been committed to providing professional testing equipment and services to customers around the world, including barrier properties, physical and mechanical properties, sanitary performance, and other types of testing equipment and services related to pharmaceutical packaging. You can visit the website of Jinan Languang Corporation for detailed investigation or Call us directly . The more you understand, the more you trust! Labthink expects to enhance technology exchanges and cooperation with enterprises and institutions in the industry!

Copyright Notice: The article is copyrighted by Jinan Languang Electromechanical Technology Co., Ltd.

Experienced and Reliable Mold parts manufacturer of all kinds of   Core pin , Insert Pin ,Round Core Pin, for press die components, Plastic mold parts and different machine parts.We have the capacity to make a wide range of non-standard or customized Mold parts and machine parts to meet the growing demands for various industries who are aiming to develop new molds for new products which requires made-to-order service all over the world. We are able to make parts exactly according to customers` drawings or samples.

Non-standard Core Pin

Core Pin,Non-standard Core Pin,Insert Pin,Round Core Pin

Changsha Borun Mould Co. Ltd. , http://www.borunmouldparts.com