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Combination Products Testing Lab

Drug Combination Products

Our scientists provide full-service medical device and combination product support through the entire product development cycle and in post-market situations.  From medical devices for surgical, spinal, cardiovascular, urology, neuromodulation, and diabetes, to combination products including biologic delivery devices and implants our scientists are experts at developing protocols and analyzing these products and materials.

  • Liquid and Solid State Characterization
  • Defect analysis
  • Assay & Impurities
  • Trace Contaminant Identification
  • Stability/Shelf Life
  • Base resin, additives, colorant(s) and filler characterization (including regrind)
  • Extractables & Leachables
  • Component Material Identification
  • Deformulation
  • Forced Degradation & Simulated In Vivo Degradation Studies
  • Residual Solvents
  • Plastics Quality
  • Physical Characterization
    • Hardness
    • Tensile Strength
    • Flexibility
    • Energy Absorption
      • Pre/Post Processing Effect on Thermoplastic Properties:
      • extrusion
      • injection/blow molding
      • cast
      • pre/post-cured products

Techniques available include:

  • TGA, DSC, SEM, HPLC with UV-vis, RI, ELSD, and MS detection, GPC, GC with FID, TID, and MS detection. FTIR, DLS, NMR, and others

What Necessitates Device or Drug Device Combination Product Characterization?

  • Routine product development testing such as assay & impurities, raw materials qualification and stability studies
  • Regulatory considerations such as extractables & leachables assessment
  • Performance tests such as degradation or drug elution rate
  • Product failure investigations

Our Scientists have experience with:

  • Coronary Stents
    • Drug-Eluting Coronary Stents
    • Drug-Coated Stents
  • Antimicrobial Catheters
    • Polyurethane Catheter
  • Orthopedic Applications
    • Bone Cement, Including Antibiotic
    • Bone Graft Substitutes
    • Orthopedic Prostheses
  • Dental Materials
  • Ophthalmic
    • Contacts
    • Glasses
  • Wound Care
    • Including Those for Biological Dressings
    • Sutures
  • Drug Delivery & Drug-Combination Products
    • Implants
    • Drug-Eluting Beads
    • Ocular Applications
  • Photodynamic Therapies
  • Membranes & Filters
  • Flexible Tubing, Containers, Packaging, & Protective Products
  • Coatings
  • Other Medical Devices

Let’s work together to achieve your vision

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