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Material Characterization Screens for Raw Materials

Nelson Labs offers a comprehensive set of tests for characterization and screening of raw materials.This is essential to ensuring materials, components, and supply chain deliver a consistent product. Some of the tests are qualitative while others are quantitative in nature.

Generally a manufacturer will perform a risk assessment of their raw materials to determine whether these materials are accepted on a vendor’s certificate of analysis (CofA) or if additional testing or qualification of the material is required before the material is released into production.

For medical device manufacturers, this may include testing microbial properties (bioburden) of incoming product or material, chemical or physical properties of a polymer to ensure material type vs prior lots, etc. Below is a summary of tests generally recommended for 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) tests and analysis of raw materials used in pharmaceutical production (e.g., water sources).

Testing Locations

Study Outline

Differential Scanning Calorimetry (DSC)

The Differential Scanning Calorimetry (DSC) test determines thermodynamic events such as melting point, glass transition temperatures, crystallization temperatures, and other phase changes. This test is performed on polymers and liquids. It is used for material characterization, lot to lot comparisons, and sample purity.

Testing meets the criteria set forth in USP General Chapter 32 and the National Formulary 27, 891. Nelson Labs offers fast, accurate, and dependable DSC testing services.

  • ISO 10993-12
  • ISO 10993-18

FTIR (Fourier Transfer Infrared)

The FTIR test is a tool to characterize and record the spectra of known materials, to provide a basis for comparison to future samples to the known material, and to help identify unknown compounds. This technique is used to compare material from lot to lot, to identify extracted material from a finished product, to identify a contaminant on a product, and to verify cleaning processes. Materials tested include polymers, finished products, oil, lubricants, and other organic material.

Testing is performed according to criteria outlined in the USP General Chapter 32 and the National Formulary 27, 2009, Chapter 851 on Spectrophotometry and Light Scattering and Chapter 198 on Spectrophotometric Identification tests. Nelson Labs offers fast, accurate, and dependable FTIR testing services.

  • ISO 10993-12
  • ISO 10993-18
  • ANSI/AAMI BE 83 2006

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