Nelson Labs offers a comprehensive set of tests for characterization and screening of raw materials.This is essential to ensuring materials, components, and supply chain deliver a consistent product. Some of the tests are qualitative while others are quantitative in nature.
Generally a manufacturer will perform a risk assessment of their raw materials to determine whether these materials are accepted on a vendor’s certificate of analysis (CofA) or if additional testing or qualification of the material is required before the material is released into production.
For medical device manufacturers, this may include testing microbial properties (bioburden) of incoming product or material, chemical or physical properties of a polymer to ensure material type vs prior lots, etc. Below is a summary of tests generally recommended for medical device manufacturers:
- Product Bioburden
- FTIR (Fourier Transfer Infrared)
- Differential Scanning Calorimetry (DSC)
- Particulate Analysis
- Physicochemical USP Plastics Tests
- Residual Manufacturing Materials – Cleaning Validation
- Water System Validations & Monitoring
For pharmaceutical manufacturers, additional tests may include screening active pharmaceutical ingredients (APIs) for potency, purity, and impurities; chemical analyses of pharmaceutical containers and stoppers using extractables and leachables (E&L) tests and analysis of raw materials used in pharmaceutical production (e.g., water sources).