About Material Certification & Qualification
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.
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Approaches
The material certification and qualification procedure is tailored to the requirements of the specific application. Some analytical methods that are used include:Fourier Transform Infrared Spectroscopy (FTIR)
Gas Chromatography/Mass Spectrometry (GC/MS)
Melt Flow Index Testing (MFI) -
Sample Considerations
Depending on the method that is required to properly perform the assessment, 1 to 100-g of sample are typically requested.
To figure out the specific sample considerations for your testing needs please contact us.
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Experience
We have experience analyzing a vast array of polymers that are used as critical components of medical devices and products, are used for producing automotive components, or are the raw materials that are used to synthesize drugs.
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