Generic filters
Exact matches only
Generic filters
Exact matches only
Header Artwork

Find a test


Material Characterization Screens of Raw Materials

Nelson Labs offers comprehensive raw materials testing through advanced material characterization methods. We support medical device, pharmaceutical, and biologics manufacturers in assessing the chemical and toxicological safety of polymers, excipients, and other raw inputs — providing clarity and confidence in your materials strategy.

Raw Materials Testing to Ensure Product Safety and Regulatory Compliance

Raw materials are the foundation of every medical, pharmaceutical, and tissue-based product. Contaminants, unknown impurities, or variable material composition can introduce serious risks — from product failure to patient harm.

That’s why raw materials testing is essential early in the product development and manufacturing lifecycle. Nelson Labs provides advanced material characterization services to assess chemical composition, identify potential toxicological risks, and support biocompatibility strategies — all tailored to the unique regulatory requirements of your industry.

Our testing screens raw materials for:

  • Volatile and semi-volatile organic compounds
  • Elemental impurities
  • Additives, residual monomers, and processing aids
  • Extractables and leachables potential

We align our testing with ISO 10993, ICH Q3D, USP <232>/<233>, and other global standards — delivering both data and expert analysis to guide safe, compliant material use.

A summary list of available tests applicable to medical device manufacturers:

For pharmaceutical manufacturers, additional tests may include screening active pharmaceutical ingredients (APIs) for potency, purity, and impurities; chemical analyses of pharmaceutical containers and stoppers using extractables and leachables (E&L) testing and analysis of raw materials used in pharmaceutical production (e.g., water sources).

Testing Locations

  • Salt Lake City, UT, USA
  • Itasca, IL, USA
  • Leuven, Belgium

Learn more about our locations and their certifications.

Study Outline

Fourier Transfer Infrared (FTIR) Spectroscopy

FTIR spectroscopy measures molecular vibrations of organic molecules in a probed substance or material. Because the set of molecular vibrations of a material relates directly to the material formulation, this method is excellent at comparing materials in hand (or those that have been measured previously) to determine if they are the same. For example, FTIR can be used to determine if a sterilization process harms a material by comparing the spectra of the material before and after the process. For pure chemicals or materials, FTIR can assist in the identification of the substance, for unknown mixtures like non-volatile residuals FTIR is of limited utility. FTIR is most often used to compare material from lot to lot, before and after a processing  step to check for equivalency, or to aid in the identification of particulate contamination on a product. Materials tested include polymers, finished products, oil lubricants, and other organic material.

This testing which is recommended in ISO 10993-12 and ISO 10993-13 is performed according to criteria outlined in USP General Chapter 32 and the National Formulary 27, 2009, Chapter 851.

For additional information, see individual test pages linked above for test specific study outlines.

Footer Artwork