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USP Pharmaceutical Testing (cGMP)

For many industrial applications of polymer materials it is important that the material is independently certified by a third-party laboratory.  

The independent material certification and qualification is a part of the Quality System of the manufacturer and provides assurance that the materials meet the expected requirements.  Medical product manufacturers, medical device manufacturers, pharmaceutical manufacturers, and automotive companies are examples of industrial sectors for which materials certification and qualification is applied.


The material certification and qualification procedure is tailored to the requirements of the specific application.  Some analytical methods that may be used include:

  • Fourier Transform Infrared Spectroscopy (FTIR)
  • Gas Chromatography/Mass Spectrometry (GC/MS)
  • Melt Flow Rate Testing (MFR)
  • Dilute Solution Viscosity
Raw Plastic materials are certified prior to being used to produce medical devices like these

Sample Considerations

Depending on the method that is required to properly perform the assessment, 1 to 100-g of sample are typically requested.  Contact us to figure out the specific sample considerations for your testing needs.


Examples of products we’ve testing for material certification and qualification include:

  • Medical device plastic raw materials
  • Formulated compounds for drug delivery systems
  • Automotive components
  • Raw materials for drug synthesis
  • Plastic for packaging applications