Medical Devices Analytical Testing

  • Overview
  • Extractables and Leachables Testing
  • Benefits of Medical Device Testing
  • Why Work With NSF?
  • Medical Device Testing Process

GLP and GMP Contract Laboratories, FDA Registered and DEA Licensed

NSF Health Sciences is a contract service provider to the pharmaceutical, biotechnology and medical device industries.

Our GLP/GMP laboratories, located in Bristol, CT, are FDA registered and inspected and DEA licensed for Schedules I through V.

Our services include extractables and leachables testing for pharmaceutical packaging and medical devices, clinical and non-clinical bioanalysis, oligonucleotide analysis, biocompatibility testing and toxicological risk assessment.

Our mission: To play an integral role in the development of pharmaceuticals to improve the lives of patients and their families. To develop and educate the next generation of pharmaceutical researchers and to impart to them the importance of why we do what we do.

For more information on analytical testing, please contact hstesting@nsf.org or call: +1 860.940.6550.

Extractables and Leachables Testing

Extractables and leachables analysis can be performed for all types of pharmaceutical packaging, medical devices including combination and implant devices, single-use system components and manufacturing line components.

Volatile, semi-volatile, non-volatile and inorganic extractables and leachables can be released or migrate from drug product container closure systems, devices and manufacturing lines. It is an FDA requirement to identify and to quantify these contaminants in drug products at release and on stability. Examples of these extractables and leachables include:

  • Monomers and plasticizers
  • Antioxidants and other additives
  • Coatings and mold release agents
  • Inks and adhesives

Our experts use the latest GC/MS, LC/MS/MS, LC/CAD and ICP/MS technologies to identify extractables and leachables. We develop and validate accurate and precise methods HPLC, GC and ICP.

We monitor parameters such as potency, pH, discoloration and degradation to determine extractable and leachable-induced changes that may adversely affect the quality of the product.

Key E&L Services:

Our key services in extractables and leachables analysis include:

  • Method development and validation
  • Controlled extractions under GMP and PQRI guidance
  • Identification of major extractables by GC/MS, LC/MS and ICP/MS
  • Determination of analytical evaluation threshold (AET)
  • Monitoring of leachables on drug product stability
  • Biocompatibility testing
  • Toxicological risk assessment

Benefits of Medical Device Testing

Scientific and Technical Expertise

Our scientists and technical experts come from a diverse background of experiences gained in small to large pharma biotech and medical device companies. You can be confident in our abilities to bring the correct technical expert to the discussion table faster than any of our competitors. We offer a full range of GMP and GLP analytical solutions.

A few of our core competencies include:

Method development and validation

  • Extractables and leachables testing for pharmaceutical packaging and medical devices
  • Biocompatibility testing
  • Oligonucleotide analysis
  • Clinical and non-clinical bioanalysis
  • Stability testing
  • Toxicology risk assessments

Working with NSF Health Sciences brings you:

  • A focused business model allowing concentrated analytical efforts to manage complex challenges and provide a complete and compliant data package
  • Recognized in-house industry experts who provide unmatched subject matter expertise to mitigate any complications
  • Extensive laboratory capabilities in the United States
  • Capabilities to offer study design, testing, consulting, training and agency representation
  • Project management focused on keeping all stakeholders informed throughout the entire project lifecycle
  • A single point of contact to coordinate all activities

Why Work With NSF?

The NSF Health Sciences team can serve as a key industry partner to help your company solve some of the more complicated analytical challenges facing the industry today. Our team is dedicated to establishing the trust, integrity and results required to build lasting client relationships.

Leadership Team

Our leadership team is comprised of representatives from the core areas of strategic development, technical and regulatory development, laboratory operations and marketing. Leadership team members are dedicated to providing our clients with expert services at the highest level of quality in the industry. Team members are also committed to providing the employees of NSF Heath Sciences with a rewarding growth environment that is both challenging and fun.

Our leadership team includes:

James R. Scull, Ph.D.
General Manager, NSF Heath Sciences
Email: jscull@nsf.org

Dr. James Scull has more than 27 years of pharmaceutical development experience spanning all areas from discovery support to Phase III clinical trials. His current responsibilities include providing strategic scientific and technical leadership with a global perspective to NSF's Health Sciences Division. Dr. Scull is focused on providing clients with technical expertise and project management designed to accelerate the drug development process. Dr. Scull's primary expertise is in the areas of GLP analytical chemistry, formulation, compliance and separation science. He is also an expert in conducting extractables and leachables studies and oligonucleotide analysis. Prior to joining NSF Health Sciences, Dr. Scull served as Executive Director of Pharmalytica Services, LLC, Principal Research Scientist for the DuPont Pharmaceutical Company and GLP Outsourcing Manager for Purdue Pharma. Dr. Scull holds a Ph.D. in analytical chemistry from Villanova University.

Richard C. Wedlich, M.S.
Director of Quality Assurance, NSF Heath Sciences
Email: rwedlich@nsf.org

Mr. Richard C. Wedlich has more than 30 years of R&D experience in the pharmaceutical, chemical and aerospace industries. Prior to joining NSF Health Sciences, Mr. Wedlich was Principal and Co-Founder of Pharmalytica Services, LLC, where he served as Vice President and Executive Director of Quality Assurance and Regulatory Affairs for over 10 years. He has also held the positions of Senior Engineer at the Schering-Plough Research Institute, Senior Process Safety Specialist at Chilworth Technologies, Senior Research Chemist at Olin Corporation, Scientist at Lockheed Engineering, Management and Sciences Company (NASA WSTF) and Chemist at Organon Pharmaceuticals. Mr. Wedlich has published numerous peer-reviewed, scientific articles. He holds a Bachelor of Science degree in chemistry from Ramapo College of New Jersey and a Master of Science degree in chemistry from Marquette University.

Kurt L. Moyer, Ph.D.
Director of Research, NSF Health Sciences
Email: kmoyer@nsf.org

Dr. Moyer has more than 23 years of pharmaceutical development experience spanning all areas from discovery support to marketed products. His primary expertise is in the areas of bioanalysis, extractables and leachables, method development and validation, identification of impurities and metabolites, and GLP/GMP compliance. He also has extensive experience with drugs for anticoagulant and cardiovascular therapies. In addition, Dr. Moyer provides NSF Health Sciences clients with project management that is designed to accelerate the development process. Prior to joining NSF Health Sciences, Dr. Moyer served as a Senior Research Investigator for Sanofi Aventis and a Research Scientist for the DuPont Pharmaceutical Company. Dr. Moyer received his Ph.D. in biochemistry from Villanova University.

Medical Device Testing Process

NSF Heath Sciences' medical device testing provides accurate, reliable, timely and cost-efficient contract analytical solutions. Our laboratories operate under full GLP and GMP compliance. We are FDA registered and inspected and DEA licensed to handle, store and test controlled substances (Schedule I through V). NSF uses the following analytical technologies and techniques:

  • HPLC/MS
  • GC/MS
  • HS-GC/MS
  • ICP/MS

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