Restricted Substances Impact Everyday Products
As the list of restricted substances grows, testing demands customized methods to identify issues early. This is a complex issue that requires a strategic approach.
Medical Device Testing
For medical device manufacturers, Eurofins EAG Laboratories offers unmatched capabilities and analytical expertise, a unique range of in-house techniques and instruments, and fast, flexible problem solving.
Experience and Scientific Excellence
- EAG has more than 65 years of experience in testing and is a Center of Excellence for ISO 10993-18 Chemical Characterization and ISO 10993-19 Surface Characterization.
- EAG is your single analytical support partner. Our expertise in chemical characterization, surface analysis, and materials chemistry helps clients bring their product to market. We support clients through the submission and approval process and joint meetings with the FDA to explain test methods and results.
- EAG delivers scientific rigor supported by highly educated professionals. Clients have direct access to expertise in project design and technique selection. Through a consultative approach, projects are tailored to utilize the most appropriate techniques, and clients get the right answers the first time.
Reliable Support and Shortest Industry Turnaround
- With a strong focus on communication and responsiveness, EAG provides the shortest industry turnaround. Clients also gain efficiency from equipment redundancy and a consultative approach.
Ensuring Regulatory Compliance
- EAG helps clients maintain strict adherence to the latest regulations from Notified Bodies including the FDA and those designated under the EU MDR.
- Medical device testing is performed at ISO 17025 certified laboratories.
Instrument Diversity and Risk Mitigation
- EAG has the most diverse instrument group with location redundancy to mitigate risk. We have multiple versions of key instruments used for medical device testing and are committed to consistently growing capacity through capital investment.
- By utilizing EAG expertise in the composition of a device, clients confidently assess their product’s safety and performance. For clients managing different supply chains, EAG provides redundancy of equipment and analytical services from multiple global locations.
Extractables and Leachables
EAG Laboratories applies vast experience with the materials that comprise medical devices to assist our clients in performing the necessary chemical characterization studies per ISO 10993-18 and the EU MDR. We are able to identify bioavailable chemicals released from a product through simulated use, exaggerated, or exhaustive extractions.
Use the button above to download our E&L Sample Submission Form and then check your downloads folder for the form in word document format.
- Internally-developed Part 18 testing program
- Validated methods for use across a wide variety of materials/extractables
- Driven by a protocol unique to each device
- Performed using extractions based upon 10993-12 and using the Analytical Evaluation Threshold (AET) as a sensitivity target
- Extracts are analyzed by the following techniques
- NVR with FTIR characterization
- Non-volatiles by LC-MS
- Volatiles and semi-volatiles by HS-GCMS, qToF-GCMS, and GCMS equipped with High Efficiency Sources (HES)
- Elemental impurities and heavy metals by ICP-MS
- Other techniques as required by our clients (IC, GPC, Raman, HPLC-ELSD/CAD, Pyro- GC-MS, Thermal Desorption, etc.)
- Our state-of-the-art Orbitrap LC-MS systems facilitate improved sensitivity and mass accuracy, which support achieving lower AETs and IDs reported as “unknown”
- We use a combination of internal and external mass spectral databases as well as a robust and rigorous science-based review to evaluate fully deconvolved data sets and identify the compounds present. This process ensures that identifications make sense and provide our clients with the best data so they can make informed decisions about their devices.
From R&D design screening to lot release and regulatory submission, manufacturers and suppliers are looking for in vitro testing that provides materials expertise with quick turnaround. As materials experts, we offer a greater understanding of why a certain material failed an assay. High throughput for in vitro testing is important. But when a material fails an assay, understanding why is crucial.
EAG has developed expertise in identifying and characterizing particles of an unknown origin with individual and combined compositional analysis techniques in conjunction with expert data interpretation. We have developed a library of spectra to accelerate particle identification investigations.
- Particulate controlled clean space
- Sample filtration and particle isolation
- Particulate matter testing per AAMI TIR42
- Counting and sizing via Light Obscuration (LO)
- Morphology and sizing via digital microscope
- Characterization via FTIR, RAMAN, and SEM/EDS
- Digital microscope
- Particulate analysis per USP<788> and USP<789>
- Stitched images to capture high resolution in larger field of view
- Particle counting, sizing, and morphology
- FTIR microscope
- Characterization of particles and bulk materials
- Scanning electron microscope (SEM)
- Elemental profiles of particles and bulk materials
- EDS mapping to observe spatial orientation of elements and elemental distributions
- Raman microscope
- Characterization of particles and bulk materials
- Determine approximate size of APIs or excipients within a tablet
- Count thousands of particles and collect Raman spectra for each particle on a filter
Impurity Investigations
- Isolation and characterization of visible contaminants: Optical microscopy, FTIR, SEM-EDS, Raman, TOF-SIMS
- Impurity purification and synthesis
- Organic materials: GC-MS, HPLC, UPLC
- Inorganic materials: ICP-OES, ICP-MS, XRF, XPS, Auger
As ISO 10993-19 continues to evolve, we have pioneered the utilization of analytical techniques to meet industry-expected needs. EAG Laboratories uses over 30 different surface characterization methods to provide answers to our customers throughout the medical device life cycle.
- Change control
- Product comparison
- Surface residue analysis
Nickel Leaching
EAG performs nickel leaching testing per ASTM F3306-19 Standard Test Method for Ion Release Evaluation of Medical Implants.
EAG supports cleaning validations per ISO 19227 utilizing a variety of target specific and non-target specific techniques. Our analysis focuses on the residue remaining on the devices including:
- Chemicals or substances the cleaning step intended to remove
- Residue from the cleaning process (detergents, solvents, etc.)
- Other potential contamination residue
Our engineering services provide comprehensive support of the advanced electronics used in medical devices, including chip-level ATE (automated test equipment) development, reliability and qualification testing (e.g. burn-in, temp cycling, electrostatic discharge (ESD) testing, etc.), circuit edit/debug, and root cause failure analysis using advanced investigative techniques like CT/3D x-ray, Laser Signal Injection Microscopy, and Dual Beam Focused Ion Beam (DB FIB) analysis.
As a leader in the field of semiconductor and electronics testing and failure analysis, our engineering teams have decades of industry experience and expertise with a comprehensive array of cutting-edge equipment to support a wide range of engineering needs.
We also have extensive battery characterization capabilities, including battery cycling, environmental testing, and full teardown services.
EAG Laboratories scientists are experts in medical device surface analysis, including the factors that affect biocompatibility, corrosion-resistance, crack-resistance, adhesion and bonding ability. Our laboratories investigate and understand the issues associated with surface modifications, including how surfaces may change and degrade with use and time, and also the effects of different surface finishes, such as electropolishing.
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Implementing Extractables and Leachables into Quality Control Testing Programs
E&L methods pose challenges as they transition from R&D environment to routine QC testing. Understanding these challenges will help you avoid costly delays.