Raw Materials Testing

It is critical to perform raw material testing on medical device since the quality of raw materials can impact the safety and efficacy of medical device. The impurities of raw materials can delay the development process, even cause a recall of products on the market.

With the state-of-the-art analytical instrumentation and rich experience in isolation, analysis and identification of materials, STEMart offers identification and characterization on raw materials of medical device.

Analysis Method for Raw Material Characterization

• Identification/Quantification of Impurities

Unexpected and/or batch-to-batch dependent impurities may impact manufacturing stages, ultimate stability and shelf life of medical device. Therefore, it is critical to analyze the potential problematic species in a product development process. STEMart helps manufacturers identify and characterize trace material impurities with a variety of analytical techniques including:

• Chromatography– HPLC, LC/MS, GC/MS, TOFMS, GC/FID, GC/TCD, GPC/SEC, TLC
• Spectroscopy – ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
• Microscopy – SEM, TEM, AFM, STM, LSCM
• TGA,
• TOC
• Differential Scanning Calorimetry (DSC)
• BET Surface Area/Pore Size Analyzer
• Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis (SDS-PAGE)
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Western Blot
• Complete Compendial Analysis
• Residual Solvents

During the manufacturing of medical device, multiple organic solvents are employed. However, it is not possible to completely remove these species. It is critical to determine the residual solvent levels in a product.

• Elemental Analysis/Trace Metals
• Thermodynamic Properties
• Mechanical Properties

Mechanical analysis is the bed-rock of any materials testing facility. STEMart routinely conducts a wide range of tests according to ASTM and ISO standards and understands the details of the test setup which are required to ensure successful completion.

• Morphological Properties

STEMart can perform extensive tests to visualize and understand a wide range of materials including metals, polymers, coated materials and fibers. The analysis techniques employed includes:

• Electron microscopy
• Optical microscopy
• Particle size analysis
• Molecular Weight/Crosslinking/Crystallinity

STEMart helps manufacturers characterize the molecular weight in polymers with a variety of analytical techniques including:

• Gel permeation chromatography
• Dilute solution or intrinsic viscometry
• Melt flow index

Necessity of Raw Material Testing

• QC confirmation of incoming raw materials
• Qualification of new suppliers
• Investigation of a questionable batch of material

STEMart provides raw material identification and characterization services to the medical device to help manufacturer select their suppliers, avoid costly production problems and delays, and ensure consistence of their products. If you have additional questions about Raw Materials Purity testing or would like to find out more about our services, please feel free to contact us.