Biomedical Engineering Laboratories
The Philadelphia Laboratory is proudly recognized as an ISO 17025 accredited laboratory (A2LA Certificate 2561.01). Additionally, the laboratory is fully compliant with CFR 21 Part 58, U.S. FDA Good Laboratory Practices (GLP). The focus areas of our facilities include the following:
- Mechanical Testing: Biomaterials, medical devices, cadaveric and animal models
- Tribology: Spine wear simulator, pin-on-disc, microbalances and pycnometry for sample characterization
- Biosafety Level 2 Suite: Specimen storage, dissection, and procedure suite, including fluoroscopy
- Microscopy: Optical microscopy, surface interferometer, FTIR, microCT, access to ESEM
- Plastics Characterization: Accelerated Aging, FTIR (Transmission and ATR), Mechanical Testing
- Metals Characterization: electrochemistry, hardness, metallography.
Mechanical and Durability Testing Facility
The mechanical testing facility is equipped with five servo-hydraulic load frames (displacement range: 4 inches; load range: 50 to 3000 lbs). and electromechanical frames (displacement range: 40 inches; load range: 20 to 6500 lbs). We also have customized durability test equipment dedicated to the evaluation of coronary and peripheral stents as well as heart valves. Our custom small-force, small-displacement load frames are used for testing applications requiring gram-force and micron-displacement resolution.
In addition to biomaterials characterization, we also have capabilities to functionally evaluate spinal, cardiovascular and orthopaedic technologies, assess the durability and perform wear testing of these devices (see below), conduct accelerated aging protocols, and utilize cadaveric models for evaluating medical device technologies.
Our expertise in conducting and managing wear and durability testing of orthopedic, spine and cardiovascular devices, includes not only the gravimetric and volumetric analyses, but also particle analysis and advanced metrology. More information on Exponent’s biotribology capability can be found on our biotribology page.
Biosafety Level 2 Suites
This facility contains a full-service cadaveric storage, dissection, and procedure suite to prepare tissues for evaluation of medical technologies. The suite is equipped with a fluoroscope, tissue band saw, and all of the necessary universal precautions and disposables needed to carry out cadaver-related activities. The lab is also equipped with freezer and refrigerator storage for both human and animal samples. Exponent conducts all of its cadaveric testing using IRB approved tissue collection and test protocols.
The microscopy facility has digital imaging microscopes with a variety of lighting options, as well as macro- and microscopes with wide ranges of resolution and fields of view. In addition we have a Zygo New View 5000 surface interferometer and a Thermo Nicolet FTIR spectrometer, complete with microscope and ATR attachment. Exponent staff also has access to area academic SEM and ESEM facilities. Access to microCT, MRI, x-ray, CT, and SEM/EDS facilities is also available through local academic labs and remote-view systems in other Exponent labs.
Our staff has experience with all analyses required for polyethylene regulatory approval (ASTM F648 and ASTM F2759, and the UHMWPE Biomaterials Handbook). We have similar experience for PEEK (ASTM F2026) and the PEEK Biomaterials Handbook. In addition, we have experience with applying these methods to stabilized polyethylene, polycarbonate urethanes, PEEK, and other polymers for medical device applications.
Our staff has characterized metals through microscopy, and hardness and micro-hardness. Samples can be cut, mounted, polished and etched as metallographic samples, to characterize the microstructure of materials, identify cracking, and analyze deposits. We also have experience with embedding materials for characterization using both SEM and TEM. We have access to SEM and ESEM facilities that are equipped with EDS detectors for chemical composition measurements. Additional chemical techniques include traditional FTIR techniques and ATR-FTIR techniques. The Philadelphia office is conveniently located near local machine shops that can provide short-turnaround sample alterations or fixtures.
Electrochemistry and Corrosion
The lab also has electrochemistry equipment with various sizes of sample holders, test cells, and a calibrated potentiostat, to measure dynamic currents and voltages for characterizing the corrosion behavior of devices and materials. This system can be integrated with the mechanical test equipment to make electrochemical measurements during fatigue testing. More information on Exponent’s electrochemistry and corrosion capabilities can be found here.