Test and analysis of impact resistance of the most

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Test and analysis of impact resistance of drug packaging materials (Part I)

Abstract: the falling ball impact test method is a test method for the impact performance of blister packaging base materials specified in the medical standard, but the supply of relevant equipment is less. This paper introduces the impact performance test method and test process in the medical standard, and briefly describes the special falling ball impact tester for drug packaging materials newly launched by Labthink

key words: Blister packaging, PVC hard tablets, composite hard tablets, impact performance, falling ball

drug blister packaging (PTP packaging) is widely applicable to the mechanized packaging of solid preparations such as tablets, capsules, pills, suppositories, etc. its base material is usually PVC hard tablets, but since the 1990s, A new type of foam forming base material (such as PVDC hard sheet, cold stamping forming material, PP hard sheet, COC material ②. A fixture with a small experimental force) packaged with a new type of drug aluminum-plastic blister to improve the packaging barrier performance and grade is gradually used in the production field of drugs

The impact strength is one of the important mechanical properties of materials. The impact performance test is almost blank in most places where the impact load is made; On the other hand, China's industry has developed rapidly in recent years. The impact strength of materials is used to measure the toughness or fracture resistance of polymer materials under high-speed impact, also known as impact toughness. Different impact test methods can be selected for different materials or different applications. The commonly used methods include pendulum impact test (including simply supported beam impact and cantilever beam impact), dart impact test, ball impact test, etc

dart drop impact test and ball drop impact test are the methods to test the impact performance of samples by dropping the falling body (including dart, weight and locking ring) or steel ball from a known height to impact the samples. The falling height and mass of the falling body or steel ball directly affect the test results, and the shape and size of the falling body punch will also greatly affect the results. The dart impact method is usually used in the flexible packaging industry. The relevant standards include GB, ISO, ASTM D, etc. the dart with hemispherical impact head is used, and a long thin rod is provided at the tail to fix the weight (see the figure and the written promise of quality assurance and maintenance of the external insulation system 1). It can be used to test the impact performance of plastic films and thin sheets with a thickness of less than 1mm. The falling ball impact method has been used in the impact tests of some pharmaceutical sheets and building materials

figure 1 Labthink bmc-b1 dart impact tester

2 testing requirements for blister packaging materials

due to the particularity of drug preservation, the barrier and mechanical properties of blister packaging substrates have received special attention in recent years, because low barrier properties or poor mechanical properties will affect the storage status and shelf life of drugs. At present, the barrier performance of PVC composite hard films is better, among which pvc/pe/pvdc, pvc/pvdc and other composite hard films are commonly used

in order to ensure the safety and effectiveness of drugs and control the quality of packaging materials, in 2002, the State Drug Administration formulated relevant national standards for drug packaging containers (materials) for several substrates mainly used in blister packaging in China, and then made some modifications in 2005, namely product standards YBB (pvc/pe/pvdc), YBB (PVC makes you feel more at ease), YBB (pvc/pvdc) and YBB (pvc/ldpe). In these standards, the specific index requirements and corresponding testing methods for various foamed substrates are described in detail. The manufacturers and users of materials shall test the performance indexes of foamed substrates in accordance with these standards

(to be continued)

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