Industries

Aerospace & Defense

EAG is your R&D partner, working with aerospace and defense manufacturers and suppliers to create faster, safer and more reliable aircraft and components. We use the most advanced…

EAG is your R&D partner, working with aerospace and defense manufacturers and suppliers to create faster, safer and more reliable aircraft and components. We use the most advanced analytical methodologies to answer complex engineering, materials and manufacturing problems, from evaluating the purity of new materials to confirming the characteristics of ceramic matrix composites. For research, development and production, we work alongside your technical staff to formulate and troubleshoot the next generation of aerospace and defense materials.

Chemicals & Basic Materials

For over 50 years, EAG’s scientists have applied advanced analytical techniques to solve tough problems and support R&D activities for manufacturers and users of a wide variety…

For over 50 years, EAG’s scientists have applied advanced analytical techniques to solve tough problems and support R&D activities for manufacturers and users of a wide variety of chemicals and materials. EAG offers reliable analytical results, development support for novel products, and answers to complex problems for manufacturers of chemicals used in metals, fibers, plastics, coatings, adhesives, construction materials, textiles, lubricants and more.

Consumer Products

Consumer products manufacturers and partners turn to EAG to answer R&D questions, ensure supply chain quality, respond to regulatory requirements and ensure well-supported legal…

Consumer products manufacturers and partners turn to EAG to answer R&D questions, ensure supply chain quality, respond to regulatory requirements and ensure well-supported legal arguments. EAG scientists have helped all types of consumer products companies accelerate innovation, resolve manufacturing concerns and comply with evolving regulations.

Food & Agriculture

Drive R&D productivity and keep pace with evolving environmental regulations. From agrochemical development to evaluating innovative packaging solutions, EAG scientists support…

Drive R&D productivity and keep pace with evolving environmental regulations.

From agrochemical development to evaluating innovative packaging solutions, EAG scientists support the agriculture/food s industry with scientific expertise required to enhance shelf life, ensure product safety and understand environmental impact. Whether in need of food quality investigations or help supporting regulatory filing of new chemicals, ask EAG. WE KNOW HOW.

Law

When a business’s brand and reputation is at stake, clients turn to EAG’s litigation support services for dependable scientific answers. Since 1959, our scientific expertise,…

When a business’s brand and reputation is at stake, clients turn to EAG’s litigation support services for dependable scientific answers. Since 1959, our scientific expertise, testing and testimony have supported legal strategies for intellectual property, product liability and insurance cases. Our scientists offer expertise in technology, life sciences, electronics, industrial and consumer products, having tested a broad array of materials for legal challenges. We understand the unique needs of legal projects – speed, effective communication, reliability and confidentiality.

Medical Device & Diagnostics

From initial concept and prototypes to verification/validation, submission and launch, EAG Laboratories is your partner in medical device development. From implant…

From initial concept and prototypes to verification/validation, submission and launch, EAG Laboratories is your partner in medical device development. From implant biocompatibility studies to surface chemistry for contact lenses, we have the experience and techniques to characterize, test and assure purity of medical devices and their materials, components, products and packaging. By utilizing our unique expertise in materials sciences, chemistry, electronics and regulatory support, EAG empowers device companies to create new ways to heal and improve patient quality of life.

Pharmaceuticals

Overcome R&D roadblocks with technical and regulatory know-how. For over two decades, EAG scientists have helped solve complex issues for the pharmaceutical Industry. Using…

Overcome R&D roadblocks with technical and regulatory know-how. For over two decades, EAG scientists have helped solve complex issues for the pharmaceutical Industry. Using multidisciplinary science and engineering, we help improve product development efficiency, avoid regulatory setbacks and uncover sources of problematic manufacturing issues. From GLP and cGMP studies to contaminant and packaging investigations, the scientists of EAG support every phase of the product lifecycle.

Technology

For the high-tech industry, EAG is the leader in materials characterization, surface analysis, microscopy and electronics testing. Our scientists and engineers troubleshoot and…

For the high-tech industry, EAG is the leader in materials characterization, surface analysis, microscopy and electronics testing. Our scientists and engineers troubleshoot and solve issues with consumer electronics, chip packages, printed circuit boards, displays, sensors, high-speed communications and more. We meet the demanding needs of technology innovation, enabling our clients to have confidence in their research & development, supply chains, and ultimately their manufacturing processes

Services

Materials Testing & Analysis

When it comes to understanding the physical structure, chemical properties and composition of materials, no scientific services company offers the breadth of experience, diversity…

When it comes to understanding the physical structure, chemical properties and composition of materials, no scientific services company offers the breadth of experience, diversity of analytical techniques or technical ingenuity of EAG. From polymers to composites, thin films to superalloys—we know how to leverage materials sciences to gain a competitive edge. At EAG, we don’t just perform testing, we drive commercial success—through thoughtfully designed investigations, technically superior analyses and expert interpretation of data.

Microelectronics Test & Engineering

Whether connecting the internet of things, guiding surgical lasers or powering the latest smart phone, integrated circuits and microelectronics touch nearly every aspect of human…

Whether connecting the internet of things, guiding surgical lasers or powering the latest smart phone, integrated circuits and microelectronics touch nearly every aspect of human life. In the world of technology, innovation and continuous improvement are imperatives—and being able to quickly and reliably test, debug, diagnose failures and take corrective action can make the difference between a doomed product launch and building a successful global brand. EAG offers you the world’s largest and most diverse collection of specialized analytical instrumentation, capacity to perform a variety of microelectronic tests in parallel, and the multi-disciplinary expertise required to draw true insight from data.

Litigation Support & Expert Testimony

When you need solid science and investigative engineering to address product failures, inform legal strategy, protect intellectual property or address product liability disputes,…

When you need solid science and investigative engineering to address product failures, inform legal strategy, protect intellectual property or address product liability disputes, turn to EAG. We’ve provided technical consulting, analysis and expert testimony for hundreds of cases involving the aerospace, transportation, medical device, electronics, industrial and consumer product industries. Our team of experts understands the legal process and your need for responsiveness, effective communication, scientifically defensible opinion and confidentiality. From professional consulting to data review to trial preparation and expert witness testimony, ask EAG.

Pharmaceutical & Biopharmaceutical Development Services

EAG Laboratories’ pharmaceutical development services group is now part of Eurofins Biopharma Product Testing. Eurofins BioPharma Product Testing offers…

EAG Laboratories’ pharmaceutical development services group is now part of Eurofins Biopharma Product Testing.

Eurofins BioPharma Product Testing offers unprecedented, multi-location capacity and unmatched expertise through the largest harmonized network of bio/pharma product testing laboratories worldwide. From performing IND-enabling studies to full CMC analytical and QC support, we join your R&D team as a true partner, providing expert guidance to balance regulatory expectations with expediency and cost, and approach technical challenges with flexibility and resolve.

Environmental Testing & Regulatory Compliance

Having helped develop the test methods that shape current regulatory guidelines, EAG chemists, biologists and toxicologists have evaluated the environmental impact of thousands of…

Having helped develop the test methods that shape current regulatory guidelines, EAG chemists, biologists and toxicologists have evaluated the environmental impact of thousands of active ingredients and formulations—from pesticides and pharmaceuticals to industrial chemicals and consumer products. Whether you are exploring “what if” scenarios, registering a new active ingredient or formulation, responding to a data call-in or seeking to understand the latest guidance, turn to EAG for technical excellence, sound advice, GLP-compliant study execution and expert interpretation.

Crop Biotechnology & Development

EAG combines biotechnology and protein characterization expertise with more than 50 years' experience analyzing chemical compounds in plant and environmental matrices to address…

EAG combines biotechnology and protein characterization expertise with more than 50 years’ experience analyzing chemical compounds in plant and environmental matrices to address the growing needs of the biotechnology crop industry. We offer a wide range of techniques required to fully characterize the event insertion and expressed proteins, as well as the various studies required to confirm the food, feed and environmental safety of products that represent the trait. From early-stage protein confirmation to GLP-compliant EDSP and allergenicity testing, we help you make faster, more informed development decisions and comply with evolving global regulations of genetically engineered crops.

Custom Synthesis & Radiolabeling

No contract service provider has more experience performing custom synthesis and producing isotopically labeled compounds to support product development in life science, chemical…

No contract service provider has more experience performing custom synthesis and producing isotopically labeled compounds to support product development in life science, chemical and related industries than we do. From 14C and 3H radiolabeled clinical trial materials synthesized under cGMP, to stable-labeled active ingredients for metabolism and environmental fate/effects testing, turn to EAG. We have extensive experience with multi-step and other complex synthesis projects, and our comprehensive, in-house analytical services ensure quick turnaround of purity and structural confirmation.

Techniques

Chromatography

Using an array of advanced separation techniques and innovative technology, we conduct highly precise analytical chromatography for various industries. Whether you want a closer…

Using an array of advanced separation techniques and innovative technology, we conduct highly precise analytical chromatography for various industries. Whether you want a closer look at the purity of your pharmaceutical or need to better understand an agrochemical’s components, EAG has the expertise to separate and evaluate any compound.

Mass Spectrometry

Need to evaluate the molecular structure of a compound or identify its origins? EAG knows how. With state-of-the-art tools, we can separate, vaporize and ionize the atoms and…

Need to evaluate the molecular structure of a compound or identify its origins? EAG knows how. With state-of-the-art tools, we can separate, vaporize and ionize the atoms and molecules in almost any pure or complex material to detect and obtain mass spectra of the components. We rely on decades of experience in mass spectrometry to provide our clients with precise analyses and the best detection limits.

Imaging

EAG is a world leader in high-resolution imaging down to the atomic level. We offer unmatched analytical know-how, generating extremely detailed surface and near surface images…

EAG is a world leader in high-resolution imaging down to the atomic level. We offer unmatched analytical know-how, generating extremely detailed surface and near surface images for various industries, from consumer electronics to nanotechnology. Using state-of-the-art equipment and innovative techniques, we conduct expert imaging to aid in failure analysis, dimensional analysis, process characterization, particle identification and more. If you want to investigate a material with angstrom scale resolution, you can count on EAG to get the job done quickly and precisely.

Spectroscopy

EAG offers a vast array of spectroscopic techniques to clients in various industries, from defense contractors to technology pioneers. We combine unparalleled expertise and…

EAG offers a vast array of spectroscopic techniques to clients in various industries, from defense contractors to technology pioneers. We combine unparalleled expertise and methodology with cutting-edge technology to analyze your organic, inorganic, metallic and composite materials for identification, compositional, structural and contaminant information. Whether you need expert spectroscopic analysis to improve your production process or to surmount a technical challenge, EAG is up to the task.

Physical/Chemical Characterization

Need to identify your unique material? Want to analyze the thermal properties of a sample, or measure the success of a process step? If it has to be done quickly and it has to be…

Need to identify your unique material? Want to analyze the thermal properties of a sample, or measure the success of a process step? If it has to be done quickly and it has to be done right, you can count on EAG. We offer a range of adaptable techniques and innovative methods to evaluate the physical and chemical characteristics of any compound. Our highly precise testing and analytical services will improve your production process, expedite R&D and help you conquer any technical challenge.

About

A Global Scientific Services Company

One of the most respected names in contract research and testing, EAG Laboratories is a global scientific services company operating at the intersection of science, technology and…

One of the most respected names in contract research and testing, EAG Laboratories is a global scientific services company operating at the intersection of science, technology and business. The scientists and engineers of EAG apply multi-disciplinary expertise, advanced analytical techniques and “we know how” resolve to answer complex questions that drive commerce around the world.

Our Customers

Science and technology transcend industry boundaries, and so does demand for EAG’s expertise. We partner with companies across a broad spectrum of high-tech, high-impact and…

Science and technology transcend industry boundaries, and so does demand for EAG’s expertise. We partner with companies across a broad spectrum of high-tech, high-impact and highly regulated industries. We help our customers innovate new and improved products, investigate manufacturing problems, perform advanced analyses to determine safety, efficacy and regulatory compliance, and protect their brands.

Our Company Culture

EAG’s corporate culture is firmly rooted in four guiding principles: “foster a growth mindset,” “find a better way,” “earn more loyal customers,” and “win…

EAG’s corporate culture is firmly rooted in four guiding principles: “foster a growth mindset,” “find a better way,” “earn more loyal customers,” and “win together.” Across all of our 20+ locations, you will find a true passion for science and the power of science to improve the world we live in. Hear what some of our ~1200 scientists, engineers and support personnel say about what it means to be part of EAG Laboratories.

Careers

EAG is growing, and we are always looking for talented, problem-solving oriented individuals to join our company. If you have a “we know how” spirit, we want to hear from you.…

EAG is growing, and we are always looking for talented, problem-solving oriented individuals to join our company. If you have a “we know how” spirit, we want to hear from you. Browse current openings now, and re-visit our careers page often.

Part 18: Chemical Characterization of Materials

EAG Laboratories applies vast experience with the materials that go into medical devices to assist our clients with performing the necessary chemical characterization studies per 10993 Part 18. Our scientists can help you move efficiently through the FDA approval process, providing robust data for toxicological evaluations.

How do I comply with ISO 10993-Part 18?

Standards for evaluating the biocompatibility of medical devices have been in effect for over ten years, yet recent FDA guidance emphasizes the importance of chemical characterization of materials. This includes understanding the chemistry of medical device components, as well as the materials used during the manufacturing process and production.

Also known as Chemical Characterization of Materials, Part 18 activities help assess a device’s overall biological safety, measure leachables, evaluate material equivalency and help screen new materials for suitability.

Part 18: A Step Process

ISO 10993-18 offers a five-step process for evaluating the biological safety of medical devices:

  • Step 1 – Qualitative Information
  • Step 2 – Material Equivalence
  • Step 3 – Quantitative Information
  • Step 4 – Quantitative Risk Assessment
  • Step 5 – Estimated clinical exposure to chemicals present

Device Material Expertise

Materials characterization is needed in steps 1-3 and EAG offers complete suite of services. We have years of experience evaluating polymers, metals, alloys and ceramics for device applications. Our services include:

  • Extractables and leachables
  • Characterizing materials
  • Deformulation (reverse engineering)
  • Process validation
  • Equivalency studies

Extractables and Leachables for Medical Devices

Exposure to low level chemistries in medical devices can pose a safety risk to patients.  The first step to evaluating potential risk is to identify the chemistries extracted under aggressive conditions.  Once the chemistries are identified, a toxicologist can perform a toxicological risk assessment to evaluate safety.  A leachable study can be performed using conditions to mimic real use scenarios to determine the potential for identified chemistries to leach out of the product.  EAG has expertise in extractables and leachables studies for pharmaceuticals, medical devices and consumer products.

Characterizing Materials for Devices

EAG is well-known for our materials characterization expertise, due to our over 40 years of experience analyzing materials and components, plus our vast array of techniques and instrumentation. Medical devices are often composed of a variety of chemistries, materials and components including as examples metals, polymers, electronic components, critical surface chemistries, etc.  We have developed numerous analytical methods to answer difficult technical questions giving our customers insight into low level chemistries, thin surface coatings, and contaminants.

Deformulation (Reverse Engineering)

EAG is the industry leader in the deformulation of products and materials. Also known as reverse engineering, deformulation is the separation, identification and quantitation of ingredients in a formulation. Our experienced chemists have performed deformulations on hundreds of products and have the skills and tools to successfully deformulate the most difficult materials.

Process Validation

As defined by FDA 21 CFR Part 820, where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.  We support the process validation activities for medical device development by providing reliable analytical results to ensure stability in the manufacturing process.  Often this involves developing an appropriate analytical method to test samples taken during process validation and evaluate for reproducibility in critical characteristics.

Equivalency Studies

Changes in manufacturing processes of medical devices are inevitable.  The changes could be due to a manufacturing site change, sterilization process change, process aid change, etc.  The impact on the biocompatibility from these changes must be evaluated as described in ISO 10993 part 1.  An important tool to assess these changes is to evaluate the extractables profile from the device manufactured under the original conditions and compare to the extractables profile of the device manufactured under the new conditions.

Of utmost importance is to determine the critical chemistry components have not changed with modifications to the process.  This can be evaluated through a comprehensive chemical comparative study to investigate the extractable profiles and/or surface chemistries.  Regardless of the change, please contact your EAG experts to help design an analytically sound equivalency study that meets the regulatory requirements.

EAG Laboratories: Material Characterization Experts

When you have questions about your material’s chemistry, EAG Laboratories provides comprehensive data for FDA submissions, innovation and product improvement.  From polymers to alloys to ceramics, we understand how these materials impact safety and effectiveness. With over 25 years of experience evaluating materials for Class II and III medical device materials, combined with a full suite of analytical tools, EAG offers reliable answers to materials characterization challenges.

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