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Manufacturing and Analytical Characterization - Chemical

Category: Poster Abstract

(T1230-08-50) Strength Evaluation of Pharmaceuticals and PTP Packaging

Tuesday, October 24, 2023
12:30 PM – 1:30 PM ET

    Presenting Author(s)

  • BD

    Brian Domanski

    Strategic Collaborations Scientist - Pharmaceuticals
    Shimadzu Scientific Instruments, Inc.
    Columbia, Maryland, United States

    • Main Author(s)

  • MO

    Mana Oshiro

    Shimadzu Corporation
    Kyoto, Kyoto, Japan



Purpose: In the development and quality control of pharmaceuticals and pharmaceutical packaging, it is necessary to ensure their efficacy and safety. Here the three types of tests used in the strength evaluations are introduced: compressive tests on pharmaceuticals, 3-point bend tests on pharmaceuticals, and push-out tests on PTP sheets to evaluate the strength of PTP packaging.

Methods: Testing Machine: EZ Test Compact Table-Top Tester
Load Cell: 500 N
Jigs: Compression test Upper compression plate (φ25) / Lower compression plate (φ118)
Three-point bending test: Three-point bending test jig (R0.1 mm×W80 mm) / jig platform
Push-out test: Pill push-out jig set / jig platform
Software: LabSolutions AG

Results: For the compressive test, the tablet test specimens were subjected to a maximum force of approximately 100 to 120 N, a crack formed parallel to the force direction, and the test was terminated. For the three-point bend test, the tablet test specimens used in this example each had a maximum force from 90 to approximately 100 N. A crack then formed in the center of the tablet, and the test was terminated. For push-out tests, samples were strained until a tear formed in the aluminum part of the PTP sheet, and the test was terminated when the force dropped below a certain level. The maximum force for the tablet and the capsule used here was different. A judgment can be made whether the tablet can be easily pushed out of the packaging using the maximum force, and this data can be used in product development and quality control.

Conclusion: Strength evaluations of pharmaceuticals and PTP packaging were performed using the EZ Test compact table-top tester. By selecting from the various jigs available, tests can be performed in accordance with the purpose of evaluation, such as compression tests, three-point bending tests, and push-out tests. In addition, by using LabSolutions AG, it is possible to comply with data integrity requirements, prevent test data tampering, and improve the efficiency of the work.