Medical Materials Analysis
Medical Device chemical analysis includes method development and validation, extractables and leachables, material characterization, failure analysis, quality control testing and supply chain management.
Intertek provides a wide range of chemical analysis for medical device materials and components.
Chemical Analysis for Medical Devices:
- Assay development and validation for API's and impurities
- Bioanalysis
- Identification of impurities and degradants
- QC testing for medical devices
- Residual solvents determination - volatile organic compounds (VOCs) and organic volatile impurities (OVIs)
- Physical chemical properties (pH, viscosity, melting point, osmolality, osmolarity, loss on drying)
- Sampling and analyses of water for controlled pharmaceutical environments
- Material Characterization and Failure Analysis for Medical Devices
- Biomaterial testing and analysis
- Process residuals analysis
Extractables and Leachables Testing
- Leachability and migration studies
- Identification and quantitation of E/L
- Determination of role of additives in polymer formulations
- Evaluation of stabilizers for reducing leachability
- Formulation of polymer test samples to assess potential leachables
- Evaluation of packaging laminates and materials
- Extractables and Leachables Analysis
Interaction Assessments in Combination Devices
- Assay development for API-device interactions and material compatibility
- Impurity identification and degradation pathways
- Evaluation of interaction with packaging materials
Stability and Medical Device Testing
- Comprehensive capabilities to evaluate slow elution, low solubility dissolution and controlled drug release patterns (DRP)
- On-site stability and storage - walk-in chambers for ICH conditions, and reach-in chambers for special conditions
- Stability Testing and Storage
Supply Chain Management for Medical Devices
- Compliance audits for cGMP, GLP and ISO
- Risk assessment analysis
- Vendor qualification
- Training and program development
Related Medical Device Services:
- cGMP Pharmaceutical Microbiology Services
- Chemical Analysis for Medical Device Components
- Antimicrobial Coatings Efficacy
- Medical Device Materials Failure Analysis
- Medical Device Polymer Materials Testing
- Extractables and Leachables
- Wound Care Product Analysis
- Regenerative Medicine Analysis and Certification
- Biomaterials Testing Services
Related Services
Request more information to see how Intertek can help your organization with Medical Materials Analysis.