A client came to us with a unique need for a needle penetration test fixture that would meet their requirements for reporting, testing procedures, and custom tooling. CSC Force was able to develop a unique five position rotating test fixture for this purpose. The client is a large manufacturer of needles that are used for surgical sutures. Our team manufactured a fixture that allowed for faster and more streamlined testing of the product on the manufacturing floor.
Testing Standards & Requirements
The client’s needles were tested for sharpness by performing a penetration test in polyurethane film, according to ASTM F3014 standards. These standards are used to assess the penetration force of a surgical needle through a chosen media. The method used requires the needle to be passed through the chosen media at a selected speed and path to apply force on the load cell. This test is created to determine the needle’s resistance to penetration as a function of its shape and coating.
The scope of the test method is used for testing sharp and blunt needles that are designed for the purpose of making surgical sutures. Both straight and curved surgical needles can be tested using this method. This test method assumes that the needles would have already passed all applicable quality standards and that they would have no physical malformations that might impact the test results. The test requires the needle to be passed through the medium and records its ability to do so multiple times, according to the ASTM F3014 standards.
Testing Machines Used
CSC Force used a Lloyd Instruments Testing System (LS1) for this needle penetration test solution. The new LS1 model is designed to measure forces up to 1kN (225 lbF), making it ideal for routine quality control testing or complex multi-stage tests. An extensive library of tests can be performed using this very versatile material tester, including compression, tensile strength, peel, shear, flexural, and kinetic. The LS1 is a new generation single column high precision materials testing machine that is used across many industries.
The Lloyd Instruments Testing System provided FDA 21 CFR Part 11 compliance for data security, automated reporting, and insertion and extraction force/distance data in an easy-to-use NEXYGENPlus material test and data analysis software package. 21 CFR Part 11 sets the ground rules for automated record-keeping systems for organizations that are subject to FDA oversight, which includes the manufacture of needles for surgical sutures. The regulations outlined in Part 11 help companies to automate and streamline the manufacturing and quality processes.
A Successful Solution
CSC Force worked extensively with this particular client from the very beginning of the project. We were able to recognize the unique needs of the client with regard to reporting, testing procedures, and custom tooling, as required by industry regulations. We consider our efforts to find the best solution for our clients to be “standard” services, which are offered at no additional charge. We are proud to provide excellent customer service to our clients.
The use of top quality testing machines and mechanical force gauges to meet the needs of our customers is a big part of what we do here at CSC Force. This is why we only work with the industry’s top brands. We are a stocking distributor for Dillon, Chatillon, CDI, Lloyd Instruments, Mecmesin, and Mark-10 products. Our team can also provide excellent testing machines and other products from well-known manufacturers, including MSI, Rice Lake, Larson Spring Testers, Ohaus, Sturtevant Richmont, and Tohnichi. We carry a wide variety of mechanical force gauges, digital force gauges, torque gauges, spring testers, test stands, and software.
If you are interested in learning more about the Lloyd Instruments Testing System used in this case study for a Needle Penetration Test, contact our team. We can discuss your force measurement needs and help you to find a custom solution. Give us a call at 413-789-3086 or 1-800-866-FORCE.