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Mechanical testing on Pharmaceutical Packaging and Medical Devices

Mechanical testing on Pharmaceutical Packaging and Medical Devices
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Mechanical testing on Pharmaceutical Packaging and Medical Devices - 1

LabthinkInstruments Co.,L TD 144 Wuyingshan Road, Jinan, China Tel: +86-531-85811021 85864214 Fax: +86-531-85812140 E-mail: trade@labthink.cn Overall Realization of Comprehensive Mechanical Testing on Pharmaceutical Packaging and Medical Devices Abstract: New materials and new solutions are enjoying increasing applications in the field of pharmaceutical packaging and medical devices; yet, the limitations of existing testers are becoming acute. Thus, how to eliminate deviations caused by changes of standards, materials and external forms, is greatly concerned by manufacturers and testing institutions. Based on the situation, Labthink has proposed a set of solutions, which can not only enhance instrument applications, but also have advantageous features in testing range, costs, maintenance, operation safety, structural optimization and extended applications, etc. Keywords: pharmaceutical packaging, medical devices, syringe, syringe needle, ampoule Pharmaceutical packaging and medical devices are directly linked to life and its safety; a high standard for their safety is set forth with strict and complete testing requirements. However, owing to the variety of pharmaceutical packaging and the complexity of external forms of medical devices, a full set of tests for one specimen needs testing several items with several testers. Moreover, because of the unique external forms of the specimen, the instrumental compatibility is not ideal. Besides, the change of standards, replacement of materials and variation of external forms, have brought about new subjects for manufacturers and testing institutions. 1. Limitations of Specialized Testers At present, new materials, new packaging forms and new external designs have found their applications in the fields of pharmaceutical packaging and medical devices. Such new developments are beneficial to offset the existing defects in traditional packaging forms, which make specialized testers devalued with the changing product design. At the same time, re-development of those testers based on new standards is costly. Take rubber stopper as an example, which is one of the important parts of the glass IV bottle. It’ strictly required s in standards for the parameters of rubber stoppers. However, with the popularization of plastic IV bottle and bags, rubber stoppers and glass IV bottles are gradually disappearing. Correspondingly, the specialized testing instruments for rubber stoppers are less likely to be used, or even abandoned. 2. Labthink Testing Solutions Based on the development of pharmaceutical packaging and medical devices, Labthink introduces MED-01 Medical Packaging Tester, an instrument for testing pharmaceutical packaging and medical devices. The instrument applies to the mechanical property testing of syringe, hypodermic needle, ampoule, rubber stopper and flexible medical pouches, such as PVC blood pouches and platelet bag as well as single or double chamber IV bags, etc. The testing subjects can be further increased. Though varied in external forms and different in materials, they share generality in structure for mechanical testing. Therefore, the development of an instrument with multiple testing components is feasible for the new testing demands.

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Mechanical testing on Pharmaceutical Packaging and Medical Devices - 2

LabthinkInstruments Co.,L TD 144 Wuyingshan Road, Jinan, China Tel: +86-531-85811021 85864214 Fax: +86-531-85812140 E-mail: trade@labthink.cn Labthink MED-01 Medical Packaging Tester can test piercing force of rubber stoppers and syringe needles, breaking force of ampoule, external-pressurized sealability of flexible plastic containers, combination force of syringe barrel and needle hub, unmating force of needle shield, sliding performance of plug stopper and dovetail property, etc. This newly developed instrument is in strict compliance with YBB00042005, Halogenated Butyl Rubber Stopper...

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Mechanical testing on Pharmaceutical Packaging and Medical Devices - 3

LabthinkInstruments Co.,L TD 144 Wuyingshan Road, Jinan, China Tel: +86-531-85811021 85864214 Fax: +86-531-85812140 E-mail: trade@labthink.cn terms so as to strengthen the practicability of each sensor, to eliminate useless configuration and to reduce instrumental costs. Moreover, though multiple testing items are configured, addition or deletion of configuration is available. Thus, quantity of the instruments can be reduced, which can facilitate instrumental management and save spaces in the labs. Meanwhile, owing to the regular calibration requirements for mechanical testers, MED-01...

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