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 Testing Facility
The mechanical testing facility is equipped with three servo-hydraulic load frames (displacement range: 4 inches; load range: 50 to 3000 lbs). and an electromechanical frame (displacement range: 40 inches; load range: 20 to 6500 lbs). The lab also has a custom small-force, small-displacement load frame for testing applications requiring gram-force and micron-displacement resolution.
In addition to biomaterials characterization, we also have capabilities to evaluate spinal and orthopaedic technologies, perform wear testing (see below), conduct accelerated aging protocols, and utilize cadaveric models for evaluating medical device technologies.
Tribology
The lab contains an MTS spine-wear simulator, which conforms to both the ASTM and ISO total disc replacement wear-test standards. Additionally, we have developed custom protocols on this system to test nucleus pulposus replacement materials, flexion- and extension-limiting devices, and validated wear-test protocols with retrieved components. The lab also has an AMTI Orthopod with a variety of orthopedic bearing material counterfaces (CoCr, Ceramic, and Polymeric).To fully characterize all wear samples, the lab is equipped with a full range of balances to perform gravimetric assessments, and the microscopy facilities (see below) to provide full documentation of components before, during, and after each test. More comprehensive analysis of samples can also be conducted with white light interferometery, microCT, pycnometry and scanning electron microscopy.
Biosafety Level 2 Suite
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.
Microscopy Facility
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.
Polymer Characterization
Our staff has experience with all analyses required for polyethylene regulatory approval (ASTM F648 and ASTM F2759, and the UHMWPE Biomaterials Handbook). In addition, we have experience with applying these methods to stabilized polyethylene, polycarbonate urethanes, PEEK, and other polymers for medical device applications.
Metals Characterization
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.
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.
Electrical Testing Lab
Philadelphia’s electrical testing lab allows for rapid testing of electronic devices and systems. Testing equipment includes a deep memory digital storage oscilloscope, power supplies, function generators, data acquisition modules, and various handheld meters for making measurements in the lab or off site. ESD safe bench and an SMD and through-hole rework station are also available.