Pharmaceutical & medical Painless syringe
The humble syringe has always been an extremely important medical device, even before the coronavirus pandemic. Syringe manufacturers must ensure thorough testing has been performed which is appropriate to the specific design—with careful consideration of the test system’s specification to meet accuracy, repeatability and legislative objectives. Robert Egginton, Mecmesin UK sales manager explains how to achieve confident syringe testing that is as painless as possible.
InTRodUcIng ThE SyRIngE The medical syringe itself is actually just the cylinder and plunger mechanism by which liquid medication is delivered to the patient, but by connecting it to other upstream or downstream components, a valuable and versatile system is created. The final connection is often, of course, a needle—creating a needle injection system (NIS)—but not in every case; an oral syringe is used to ‘point and squirt’ directly from the barrel tip into the mouth. The differing designs of these sub- components and connectors mean that often quite complex interactions occur as the syringe is assembled, prepared, used, potentially re-used, and stored. During its lifecycle, the device not only comes into contact with the patient and the administering healthcare professional—sometimes the patient themselves—but also its original packaging, medicine vials and finally, disposal containers.
TESTIng TIMES The medical devices and pharmaceuticals sector is highly regulated, driven by compliance and auditing processes. Syringe manufacturers must ensure thorough testing has been performed which is appropriate to the syringe’s specific design. International standards bodies publish procedures enabling manufacturers to test the functionality and integrity of each subcomponent and sub-assembly that may be part of a complete syringe system. These international test standards are
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important not only in manufacturing quality control but also form the basis of functional performance and new product development optimisation in design and R&D departments. In order to confidently meet standards, a syringe manufacturer must be able to measure the relevant parameters required to push, pull and twist the various mechanisms which may all apply to a single, complete system. They must also ensure that the results are accurate, repeatable and reproducible—and formally documented.
RESolUTIon noT REvolUTIon Mecmesin manufactures systems and instruments to measure force and torque, allowing medical device manufacturers to apply compression, tension and turning effort to their products, calculate the results, and so meet legislative requirements. A Mecmesin force tester, or torque
tester, is able to test a wide variety of products and components by virtue of interchangeable loadcells and gripping fixtures. In this way, a so-called Universal Testing Machine (UTM) can be quickly configured to be a dedicated tester for the range of functions required of a syringe system. In terms of functionality, quite light loads are often applicable—devices must operate easily, assemble reliably and be able to be used by the elderly and infirm. In contrast, the product must be strong enough to perform as expected and
June 2021 Instrumentation Monthly
testing
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