Testing to characterize raw materials and components of medical devices is available to help assure biocompatibility and reproducibility in manufacturing.
Test Methods:- Analytical Method Development and Transfer
- Physicochemical Tests - Plastics - USP
- FTIR
- Liquid Chromatography - MS, FTIR, VIS, GPC
- Gas Chromatography - FID, MS
- Trace Elements - AA, ICP
- Physical/Mechanical
- Specific Gravity
- Durometer Hardness
- Melting Point Determination
- Surface Characterization - SEM
- Moisture Determination
- Monograph Tests - BP, EP, JP, USP
- Refractive Index
- Rotational and Capillary Viscosity
- Thermal Analysis - DSC, TGA
- Osmolarity
- Polymer Extractables - ASTM, CFR
- Container/Closure Leachables/Extractables
- Particulates for Injectables/Medical Devices
- Protein and Peptide Assays
- Heavy Metals, USP Methods I and II
- Ion Content Analysis
- Purified Water Testing - BP, EP, JP, USP