Break Loose Glide Force
Break loose force is a critical parameter defined in USP <382>, representing the force required to initiate the movement of the plunger in a syringe or cartridge. This measurement is key to assessing the functional suitability of these devices. Discover how your syringes and cartridges measure up against USP <382> standards and ensure the break loose force of your devices meets the mark for optimal functionality with Gateway Analytical. Contact us now for a comprehensive assessment
Force Measured, Quality Assured
Break loose force is defined in USP <382> and details the variables and considerations for assessing their functional suitability. Test samples are nominally filled with product or a product proxy. For syringes and cartridges that do not have a fixed or staked needle, the test is performed by adding connecting devices such as needles, needleless Luer connections, adapters, and transfer units as per the intended product-use directions.
Setting Standards in Syringe Functionality
For comprehensive testing and evaluation of break loose force as per USP 382, Gateway Analytical offers specialized services. Our expertise ensures that your syringe and cartridge products meet the highest standards of functionality and ease of use. Contact Gateway Analytical for detailed break loose force testing and ensure your products comply with regulatory standards.
Accurate Force Testing for Safer Healthcare
The break-loose and glide force tests are performed using a mechanical testing machine. The machine should be capable of attaching to the test sample, depressing the syringe plunger at a constant linear rate, and continuously measuring and recording the force. Elution speed and measurement sampling rate must be factored into the test setup, and when possible, test speeds should mimic product administration flow rates, demonstrating actual usage forces.
The test measures the break-loose and extrusion forces from the start of the plunger movement to contact with the syringe barrel shoulder. Test results are reported in Newtons.
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