MEDICA 2011

Meet the Intertek Team

Stand 16G18-2

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Stand Location Map

Intertek QTI

P.O. Box 470
291 Route 22 East
Salem Industrial Park
Whitehouse, NJ 08888
USA

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Intertek ASG

P.O. Box 42
Hexagon Tower
Blackley
Manchester, M9 8ZS
United Kingdom

 

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USA:+1-908-534-4445 x600
EMEA UK:+44 161 721 5247
Switzerland:+41 61 686 4800
 
 

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: 

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

 

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