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, 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
• RoHS Testing Services

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

Request more information to see how Intertek can help your organization with Medical Materials Analysis.