Syringe Testing Fixture for Determining Force Required to Eject Fluid and Medication
A pharmaceuticals manufacturer was required to investigate the forces necessary to eject medications from various types of needles and syringes, and asked for our assistance in determining the best testing system configuration to perform the test. The purpose of this testing was to be able to collect force versus time data, as well as to determine the peak load and load values at specified points of plunger displacement. Other types of results often requested: the peak force (or "break-away force") that marks the force required to begin fluid ejection, and the average force (or "sustaining force") that marks the force required to maintain an even flow of fluid out of the syringe.
Our syringe testing fixture can accommodate a wide variety of syringe sizes. It uses an insert that is machined to match the syringe diameter. Several inserts can be used for a variety of syringe designs. A compression platen is mounted at the crosshead and is used to push the plunger and eject fluid. The fixture is compatible with any of our universal testing systems and Bluehill® Software is capable of both test control, and all results and calculations needed.
Records management compliance with FDA 21 CFR § 11 is non-negotiable for many Medical Device and Pharmaceutical companies. ComplianceBuilder™ is a stand-alone, add-on compliance solution that can be integrated with our Bluehill Software, providing features necessary to meet the latest FDA 21 CFR § 11 regulations.
Detailed description of fixture that is designed to evaluate the performance of syringes and syringe/needle combinations. Primary uses are determining breakaway forces at the beginning of injections as well as sustaining forces throughout the injection process.
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5900 Universal Testing Systems are engineered for precision, built for durability, and offer the flexibility for changing requirements. They are designed with standard and optional features that increase testing efficiency and improve the testing experience for the operator. A wide range of models are available for testing capacities from < 100N up to 600kN.
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ComplianceBuilder™ is a stand-alone, add-on compliance solution designed for Medical Device and Pharmaceutical companies to help ensure they meet the latest FDA 21 CFR § 11 regulations.
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Webinar on Bluehill Software presented by Jim Ritchey and Frank Lio on July 15, 2004, October 27, 2004 and December 8, 2004.
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