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Non-Destructive, Low Cost, High Speed Medical Grade Alloy Verification


The DELTA Line Medical Device Component Inspection

Challenge

There is no more challenging or regulated use of alloy materials than implants for the human body. Implantation alloys are selected based on a combination of characteristics including immunity to corrosion, bio-compatibility, strength, low modulus and density, and the capacity for joining with bone and other tissue. As biomaterial science evolves, new and novel metal alloys are being used for critical applications. Small changes in the concentrations of constituent elements or impurities can be critical as they may alter strength-to-weight ratio and corrosion resistance. As such, thorough quality control testing is necessary. Medical device manufacturers require easy-to-use, accurate and precise analytical techniques to keep up with progress and provide on-the-fly material identification as part of the overall documentation and compliance process.

Delta Handheld XRF Analyzer in docking station

Material compliance technology must be cost-effective while not extending any time-to-market for product. The compliance technique should also be able to acquire required information, such as alloy identification and composition, without destroying or affecting the product in any way. And procedures must be maintained and executed for identifying each unit, lot, or batch of finished devices and components, all documented in the Device History Record (DHR).

Solution

With its precision, accuracy, advanced electronics and data logging capabilities, the DELTA provides a solution for this critical alloy material verification.

The DELTA handheld XRF is ideal for fast verification of metal alloys used in the Medical Device Industry. All analyses are completely non-destructive. The DELTA provides alloy composition chemistry (up to 30 elements simultaneously) and grade identification within seconds. The user interface also provides an instant comparison of analysis results to engineering grade specifications, identifying "out of spec" elements and tramp constituents. Up to 100,000 readings, including sample identification information and spectra, can be stored and preserved for data integrity as part of the DHR (§820.72).

Delta Handheld XRF with metal

The DELTA offers excellent Limits of Detection (LOD's) and light element analysis as a result of its unique 4W, 200µA (max) x-ray tube, state-of-the-art electronics, Silicon Drift Detector, floating point processor, and redesigned analytical geometry. All this in a durable and industrialized, handy analyzer weighing in at just 3.25 lbs.

DELTA Results:

Analysis results from a DELTA analyzer are shown below. Screenshots from the direct analyses of two different proprietary implantation alloys, labeled PGA1 and PGA2, are shown. These samples were analyzed directly, without preparation or modification. (XRF analysis is completely non-destructive.) Analysis times were 20 seconds in duration, for the sake of composition analysis precision. (Quick sorting and alloy identification can be achieved in as little as 1-2 seconds. Longer analysis times can be used for chemistry monitoring. For example, Fe, a strictly regulated constituent in Co alloys, can be closely measured at low concentrations to ensure compositional compliance.) Results can be quickly exported to a database for archiving. The DELTA Reporting Software can instantaneously produce formal analysis reports, or the DELTA analyzer can send results directly to a wireless printer for instant documentation.

X-ray of knee with part
DELTA Screenshot: Analysis result of sample PGA1
DELTA Screenshot: Analysis result of sample PGA2
DELTA Screenshot: Analysis result of sample PGA1
DELTA Screenshot: Analysis result of sample PGA2
Olympus IMS
应用所使用的产品

DELTA合金与金属手持式X射线荧光分析仪可以进行专业性极强的材料化学分析,可快速精确地辨别合金级别和纯金属。这款分析仪在数秒钟之内就可做出合金化学成分的辨别及定级。从简单的分拣到复杂的级别划分,从来料检测到最后产品的核查,都可用到这款分析仪。
DELTA Element是一款性价比极高的手持式X射线荧光(XRF)分析仪,这是一款经过优化的分析仪,可以进行废料金属的分拣、材料成份的辨别(PMI)、合金的质量保证和质量控制,以及贵金属的分析。
DELTA Professional将硅漂移探测器(SDD)和一个4W优化X射线管结合在一起使用,可在检测速度、检出限及可检元素的范围方面提供极为优质的性能。它可以分析合金和矿石中镁(Mg)及原子数更高的元素。DELTA Professional是Olympus所生产的最具问题解决价值的手持式XRF分析仪。
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