Medical packaging validating


16-Nov-2017 09:37

medical packaging validating-47

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These forces will be determined by a range of variables, the size of the syringe/needle aperture, the ‘fit’ of the plunger within the syringe barrel, the materials used and, in service, the density of the tissue substrate and the viscosity of the liquid.The syringe must be developed with the optimum balance of these variables to assure consistency and usability.One specific example uses a computer-controlled test stand to compress a plaster of Paris dome-shaped sample (which has comparable mechanical properties to hard, brittle food items, like nuts) to measure ultimate bite strength.Dental model attachments to the compression plate represent the tooth profile within the jaw and in addition to the force measurement, further evaluation of the fractured sample – size and number of fragments - also influence the scientific appraisal of mechanical performance.Grasping of the corner of the foil in a manner akin to human fingers will require suitably sized pinch grips.In order to focus the test on the bonding around the blister perimeter, the surface needs to be kept flat and in a non-deformed condition, to avoid introducing inaccuracies into the process and ensure repeatability.Typically, a constant rate of plunger depression (and withdrawal) of the order of 100 mm/min is indicated for this test.

However, a successful seal at low torque improves at higher torque. The most common test involves tightening the Luer lock connection between a needle housing and a fluid-filled syringe to a pre-determined torque, and visually inspecting the joint for leakage.Syringes must deliver and extract fluids in a smooth, controlled manner; a plunger that is too easy or hard to actuate, or that stalls or judders on depression will not perform reliably during injection or aspiration.The testing of manually operated sterile single-use hypodermic syringes for aspiration (and expression) force is essential under industry standards.Once failure occurs, the tags must be unusable as part of the traceability requirements.



DDL's engineers are experienced in ISO 11607, the foremost guidance document for validating packaging for terminally sterilized medical devices.… continue reading »


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