Medical Materials Analysis

Medical device chemical analysis includes method development and validation, extractables and leachables, material characterization, failure analysis, QC testing, supply chain management.

Intertek provides a wide range of chemical analysis for medical device materials and components.

Chemical Analysis for Medical Devices:

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

 

 
Need help or have a question? +1 800 967 5352
 

Need help or have a question?

USA:
+1 800 967 5352
EMEA UK:
+44 161 721 5247
Switzerland:
+41 61 686 4800