EUROLABoffers a comprehensive range of tests for the characterization and screening of raw materials. Material screening helps manufacturers select their suppliers and ensures a consistent product is delivered through routine monitoring of materials. Some screening tests are qualitative, providing only composite identity-related information, while others are qualitative in nature.
Manufacturers should evaluate potential raw materials to determine if the device is of sufficient quality to meet its goals and be put into production. By reviewing the information provided by the supplier in technical documents such as material assessment, certificate of analysis (COA), or where the information provided is not detailed enough, testing may be required to ensure that the material quality meets the required specifications. .
For medical device manufacturers, testing on incoming materials may include biological charge, chemical composition (to ensure that the material does not contain CMR), or the physical-chemical properties of a material to ensure that incoming materials are unlikely to subsequently cause biocompatibility issues or to check consistency. very. Below is a summary of available tests for display materials applicable to medical device manufacturers.
Additional tests for pharmaceutical manufacturers include screening active pharmaceutical ingredients (APIs) for potency, purity and impurities; Chemical analysis of pharmaceutical containers and stoppers using extractables and leaks (E&L) and analysis of raw materials used in pharmaceutical production (e.g. water sources).
Differential Scanning Calorimetry (DSC) determines the intrinsic properties of polymers due to phase changes such as crystallization temperature, glass transition temperatures and melting points. Because the temperatures associated with phase changes are closely related to the chemical formulation and internal structure of a material, this test can be used to compare material from lot to lot by scanning for differences.
The tests recommended in ISO 10993-12 and ISO 10993-18 meet the fourth criteria in USP General Part 32 and National Formular 27, 891.
FTIR spectroscopy measures the molecular vibrations of organic molecular vibrations of organic molecules in a probed substance or material. Since the set of molecular vibrations of a material is directly related to the material formulation, this method is excellent for comparing materials at hand (or previously measured) to determine if they are the same. FTIR, for example, can be used to determine whether a sterilization process will damage a material by comparing the spectra of the material before and after the treatment.
For pure chemicals or materials, FTIR can help identify the substance, for unknown mixtures such as non-volatile residues FTIR has limited use. FTIR is often used to compare material from batch to batch before and after a process step to check equivalence, or to help identify particulate contamination on a product. Materials tested include polymers, finished products, oil lubricants, and other organic materials.
Recommended in ISO 10993-12 and ISO 10993-13, this test is performed according to the criteria set out in USP General Section 32 and National Formular 27, 2009, Section 851.
EUROLAB, with its highly expert team and internationally accredited laboratories, Characterization and Screening Test of Raw Materials It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
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